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Career opportunities

Consider a rewarding career at Rho

A career at Rho provides an opportunity to make a positive impact on people's lives through innovative clinical trial research. In addition to offering a comprehensive benefits package, we are proud of our family-friendly, collaborative corporate culture that provides opportunities for growth. If you think you possess the drive and talent to succeed at Rho, please browse our career opportunities.

Open positions:

All Positions


Administrative Assistant

Chapel Hill, NC

(Job Code: 00378) - Apply...

Rho is seeking an individual to provide comprehensive administrative support for the Immune Tolerance Network team. Primary responsibilities include, but are not limited to:

  • Organizing and coordinating meetings/calls both on-site and off-site and recording minutes
  • Tracking and ordering supplies
  • Maintaining calendars
  • Developing, maintaining, and supporting the project website, including controlling access and updating web content
  • Making travel arrangements and handling meeting reimbursements
  • Completing other research and administrative tasks as needed

Basic Qualifications:

  • Bachelor’s degree
  • Highly organized, with exceptional attention to detail
  • Strong written and oral communication skills
  • Ability to multi-task
  • Excellent inter-personal skills
  • Thorough knowledge of Windows applications including Word, Excel, Outlook and PowerPoint

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Administrative Assistant

Chapel Hill, NC

(Job Code: 00386) - Apply...

Rho, Inc. is seeking an individual to provide administrative support, interact with internal and external clients with a professional demeanor, complete special projects as assigned, and process correspondence and other documents. Responsibilities include Administrative work as Assistant to the VP of Business Operations. Making travel arrangements and being the liaison between Rho, Inc. and the travel company. Providing administrative support for all departments. Working at the front desk as a backup answering and screening telephone calls on a multi-line system, arranging overnight shipments and mailing and maintaining office supplies. Other responsibilities include interacting with vendors, completing special assigned projects, and processing various correspondence and documents. The candidate must be a team-oriented professional with strong initiative. Candidates must be highly organized with exceptional attention to detail, have strong written and oral communication skills, prioritization skills and be able to work under tight deadlines. The candidate must have the ability to multi-task, have excellent inter-personal skills, maintain confidentiality and use of good judgment and sensitivity.

Basic Qualifications:

Associates Degree in Business or Secretarial Sciences and 3 years of administrative experience or Bachelor's Degree in Business (or related field) and 1 year of administrative experience or 5 years of related administrative experience and no degree. Will consider equivalent amount of education and experience. Candidates must have thorough knowledge of Windows application including Word, Excel, Outlook and PowerPoint.

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Associate Clinical Data Project Manager (2)

Chapel Hill, NC

(Job Code: 00374) - Apply...

The person in this position possesses a strong knowledge of the data management process. Responsible for leading the data management activities on one or more projects, facilitating tasks within the centralized data management team and interfacing with the client and project team. Ensures that data management services are delivered in a consistent, high-quality manner. May serve as a data management representative during the business development process

Essential Duties and Responsibilities include the following (additional duties may be assigned):

Project Management Duties:

  • Responsible for timely and accurate delivery of all data management deliverables

  • Serves as the project and Sponsor liaison for all data management issues, providing appropriate level of communication and customer service, and with supervision, recognizes additional business opportunities

  • Maintains contact with project stakeholders to determine project requirements and level of satisfaction with progress and performance

  • Communicates clearly and effectively with the internal project team members (including but not limited to, project managers, statistical programmers, CRAs, Software Developers and Biostatisticians) and Sponsors

  • Plans, implements, supervises and conducts clinical data activities for multiple Phase I – Phase IV clinical trial projects

  • Participates in the logistical setup of new projects including activities related to project initiation

  • With supervision, ensures budget adherence by internal and external team members related to data management deliverables

  • With supervision, ensures appropriate tracking and follow up for out of scopes activities related to data management deliverables

  • With supervision may assist contracts and business development with RFIs, RFPs and bid defenses

  • Establishes and maintains data management deliverable timelines

  • Participates in project team meetings and ensures effective team operations

  • Tracks data management action items and follows-up with team members as needed

  • Reviews and maintains data management related project documents, files and correspondence

  • Ensures that all data management aspects of projects are performed in compliance with corporate standard operating procedures (SOPs), Sponsor SOPs (if applicable), Federal law, and ICH and Good Clinical Practices (GCP) guidelines, where applicable

Data Management Duties:

  • Reviews study protocols to ensure customer requirements are accurately captured and ensures consistency across client studies

  • Performs study setup, testing and system validation.

  • May oversee the set up of the clinical database, including developing the structural specifications and project set up in the Data Management System

  • Creates and maintains data management plans

  • Oversees the development and testing of study-specific validation plans

  • Oversees the creation of all project files, study-specific guidelines and forms, and status reports

  • Oversees the design, development, and production of case report forms

  • Identifies project resourcing needs and communicates those through the appropriate channels

  • Maintains a knowledge of the pharmaceutical and data management industries and the regulations, guidelines, and guidances that pertain to the conduct of clinical trials

  • Provides study specific training as appropriate

  • Ensures quality control procedures are properly planned and implemented in a timely manner for all studies

  • Performs aggregate data review and reports any trends through the appropriate channels

  • Oversees the query generation and resolution process

  • Oversees all closure and database lock activities

The successful candidate will have Bachelors degree and 4 or more years of related experience or training; experience must include 2 years of direct or indirect data management or project management experience, preferably in the clinical trial industry.

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Biostatistician

Chapel Hill, NC

(Job Code: 00387) - Apply...

As a biostatistician at Rho, you will participate in multiple clinical trial project teams. Under the direction of a lead biostatistician, you will prepare analysis plans and specifications for analysis data sets and data displays (tables & graphs); analyze clinical trial data and interpret the results, either in a statistical report or as part of a clinical trial report; and collaborate with statistical programming on the production of datasets and displays. Communicating statistical issues as they arise both to clients and to Rho team members as well as maintaining a steady, open dialogue with study team members regarding study execution as it relates to timelines, data quality, and interpretation of the results are also key components of this position. Rho's environment is team-oriented. Good communication skills and the ability to work with a team are crucial for success. Rho's high quality standards require careful attention to accuracy and details. Strong SAS programming skills are required. This position requires a master's degree in biostatistics, statistics, or a related field, or a bachelor's degree and at least two to five years of relevant statistical experience.

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Biostatistician (3 positions)

Chapel Hill, NC

(Job Code: 00383) - Apply...

As a biostatistician at Rho, you will participate in multiple clinical trial project teams. Under the direction of a lead biostatistician, you will prepare analysis plans and specifications for analysis data sets and data displays (tables & graphs); analyze clinical trial data and interpret the results, either in a statistical report or as part of a clinical trial report; and collaborate with statistical programming on the production of datasets and displays. Communicating statistical issues as they arise both to clients and to Rho team members as well as maintaining a steady, open dialogue with study team members regarding study execution as it relates to timelines, data quality, and interpretation of the results are also key components of this position. Rho's environment is team-oriented. Good communication skills and the ability to work with a team are crucial for success. Rho's high quality standards require careful attention to accuracy and details. Strong SAS programming skills are required. This position requires a master's degree in biostatistics, statistics, or a related field, or a bachelor's degree and at least two to five years of relevant statistical experience. 3 positions

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Clinical Data Associate

Chapel Hill, NC

(Job Code: 00375) - Apply...

Responsibilities:

Duties include reviewing and cleaning of clinical data, researching and resolving data problems, assisting project leads with study set up, and other data related tasks.

Basic Qualifications:

  • Bachelor’s degree in physical science, computer science, social science (or related area of study) and a minimum of one year of experience in the clinical research industry; or the equivalent combination of education and experience.
  • The qualified candidate will be a detail-oriented self-starter

Preferences:

Familiarity with SAS and Microsoft suite products is preferred.

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Director, Business Development

Chapel Hill, NC

(Job Code: 00380) - Apply...

The successful candidate for Director, Business Development will be a goal oriented sales professional who will proactively manage all sales activities for assigned clients in accordance with the strategic goals of the company. Responsibilities include creating and implementing a sales plan, identifying new clients, facilitating client meetings with Rho operational staff, and attending local and national trade shows and conferences. The Director, Business Development will identify and develop potential new clients and cultivate existing client relationships.

The Director, Business Development must be passionate about selling, self-motivated, and have the ability to meet or exceed company sales targets. Focus will be on successfully matching Rho’s operational expertise to client needs in order to ensure customer loyalty, build brand awareness, and create market recognition. Must be able to establish and maintain effective relationships with clients and Rho colleagues, including operational staff and other sales team members. Strong negotiation and presentation skills are required.

Must have a minimum of five (5) years sales experience with a proven track record of achieving results. Sales experience in the CRO or pharmaceutical environment preferred. Must have excellent oral and written communication skills. At a minimum, a Bachelor’s degree in related area required.

This position requires a minimum of 50% travel.

This position will be based out of Rho’s headquarters in Chapel Hill, NC.

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Executive Director, Business Development

Chapel Hill, NC

(Job Code: 00381) - Apply...

The successful candidate for Executive Director, Business Development for Rho, Inc., will be a goal oriented sales professional who will proactively manage all sales activities in accordance with the strategic goals of the company. Responsibilities include creating an overall sales strategy, training and mentoring other sales team members, developing a personal sales plan, identifying new clients, facilitating client meetings with Rho operational staff, and attending local and national trade shows and conferences.

The Executive Director, Business Development will create sales messages, identify and develop potential new clients, and cultivate existing client relationships by developing outstanding rapport. The chosen candidate will rely on extensive experience and personal judgment to develop a sales strategy for all sales team members.

The Executive Director, Business Development must be passionate about selling, self-motivated, and have the ability to meet or exceed company sales targets. Focus will be on developing tactics to match Rho’s operational expertise to client needs in order to ensure customer loyalty, build brand awareness, and create market recognition. Must be able to establish and maintain effective relationships with clients and Rho colleagues, including operational staff and other sales team members. The Executive Director, Business Development will be expected to have and maintain relationships with mid- and high-level decision makers at client companies. Strong planning, negotiation, and presentation skills are required.

Must have a minimum of eight (8) years direct sales experience in the CRO industry with a proven track record of achieving results. Operational CRO or pharma experience preferred. Demonstrated leadership and management experience required. Must have strong work ethic and excellent oral and written communication skills. At a minimum, a Bachelor’s degree in related area required.

This position requires a minimum of 50% travel. This position will be based out of Rho’s headquarters in Chapel Hill, NC.

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Post Doctoral Integrated Product Development Associate (2)

Chapel Hill, NC

(Job Code: 00369) - Apply...

Rho is seeking recent post-Doctoral candidates as Integrated Product Development Associates. The Integrated Product Development Associate position is intended for individuals aspiring to lead full product development programs within the pharmaceutical industry. To this end, the candidates will first be exposed to all documents prepared as part of the product development process (including integrated product development plans, clinical trial applications, sections of Investigational New Drug applications, preclinical and clinical study protocols, investigator brochures, supporting statistical documents, integrated clinical/statistical final study reports, and sections of marketing applications.) This on the job training will be supplemented with classroom lectures and workshops to impart an overall understanding of the entire product development process. Duties of the Integrated Product Development Associate include but are not limited to:

  • Researches current literature to assist in the design of clinical studies.
  • With some supervision interacts with sponsor to determine the format, design, and direction of clinical/statistical reports.
  • With some supervision reviews and edits statistical analysis plans and statistical reports written by biostatisticians for clarity and accuracy.
  • Contributes to investigational drug brochures; summarizes animal and clinical studies, and draws conclusions as to the potential safety of the drug under study.
  • Assists in writing documents to support regulatory submissions including, but not limited to, clinical trial authorizations (INDs, CTAs), marketing authorization applications (NDAs, BLAs, NDSs, MAAs), device authorizations (IDEs, 510Ks, PMAs).
  • Interacts with the product sponsor and designated authors to determine the content and direction of scientific publications. Interacts with meeting organizers and journal editors, as appropriate.
  • Coordinates poster and manuscript development with input from physicians, biostatisticians, pharmacologists, and regulatory personnel. Edits manuscripts according to the journal or meeting style guidelines. Obtains author, sponsor, and internal approval of the final versions of abstracts, posters, and manuscripts. Ensures compliance with the SOPs for publication development.

A PhD, PharmD, or MD degree and excellent reasoning capabilities, scientific acumen, and writing capabilities are required. In addition, candidates should have a minimum of two years’ work experience (e.g., student internships, postdoctoral fellowships, laboratory positions, or project management). Working knowledge of medical terminology and basic statistical concepts is strongly preferred. Must have experience with medical, pharmaceutical, and/or research concepts . Qualified candidates will possess basic editorial and proofreading skills and will understand and perform well the process of writing (outlining, drafting, revising, and reviewing.) Must be detail-oriented, thorough, and methodical. Must be able to reduce voluminous complex scientific data to it essence in tabular or summary form. In addition, must be adaptable to changes in work duties, responsibilities, and requirements. Qualified candidates will be team-oriented individuals who keeps others informed of the progress and status of writing projects. Must be able to perform numerous tasks simultaneously without losing sight of overall objectives. Proficient with software packages including, but not limited to: Microsoft Word, Excel, Powerpoint, Project and Visio.

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Research Associate

Chapel Hill, NC

(Job Code: 00372) - Apply...

Opportunity for entry-level position with growing contract research organization providing research support for clinical trials. Duties include using Excel, Word, and SAS under the direction of a biostatistician to create deliverables for Sponsors in the pharmaceutical industry. ****

Specific job duties would include (but are not limited to):

  • Assist with the coordination of development of deliverables to Sponsors.
  • Assist with quality review of deliverables to Sponsors.
  • Use Microsoft Office tools to document team decisions, timelines, and coordination of tasks.
  • Assist with creating specifications for programmers to analyze data under the direction of a biostatistician.

Requirements:

Bachelor degree with some exposure to research methods and analysis of data is required. This individual must also be able to work independently in a team-oriented environment, have a desire to learn new skills, have strong analytical skills, pay close attention to details, and possess good written and verbal communication skills.

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Research Associate

Chapel Hill, NC

(Job Code: 00384) - Apply...

The Research Associate will assist project managers in day-to-day operations of federally-funded multi-site research studies.

Responsibilities may include:

  • Writing external correspondence, such as emails, memos, minutes and reports
  • Formatting documents and creating document templates
  • Creating and formatting Case Report Forms, manual of operations documents, and other study-related documentation
  • Maintaining project website
  • Creating slide presentations
  • Communicating with internal and external project staff
  • Filing, copying and faxing

This is an entry-level position. This is not a laboratory research position.

  • Bachelor’s degree in a scientific field or a related area of study with research emphasis
  • Past experience working with data or on research studies is desired
  • Must have effective oral and written communication skills, strong internet research skills, proficiency in MS Office Suite (Word, Excel, PowerPoint and Word)
  • Must have strong organizational skills, be able to multi-task, meet deadlines, and proof own work.
  • The ability to balance team and individual responsibilities is essential

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Research Associate (2 positions)

Chapel Hill, NC

(Job Code: 00389) - Apply...

This position provides provides research support for clinical trials. Duties include using Excel, Word, and SAS under the direction of a biostatistician to create deliverables for Sponsors in the pharmaceutical industry. ****

Specific job duties would include (but are not limited to):

  • Assist with the coordination of development of deliverables to Sponsors.
  • Assist with quality review of deliverables to Sponsors.
  • Use Microsoft Office tools to document team decisions, timelines, and coordination of tasks.
  • Assist with creating specifications for programmers to analyze data under the direction of a biostatistician.

Requirements:

Bachelor degree with some exposure to research methods and analysis of data is required. This individual must also be able to work independently in a team-oriented environment, have a desire to learn new skills, have strong analytical skills, pay close attention to details, and possess good written and verbal communication skills.

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Sr. Clinical Data Associate

Chapel Hill, NC

(Job Code: 00377) - Apply...

Responsibilities The Senior Clinical Data Associate will independently perform advanced tasks related to processing and cleaning clinical trials data, following all applicable standard and study-specific procedures. He/she will assist the project lead with study set-up. He/she may be responsible for specific portions of the data management process for individual projects. Primary responsibilities include reviewing and cleaning data, researching and resolving data issues and performing study set-up tasks which may include database set-up and testing and data validation plan testing.

  • Bachelor’s degree in physical science, computer science, social science (or related area of study)

  • Two or more years of experience in the clinical research industry; or the equivalent combination of education and experience.

  • Electronic Data Capture Setup experience is preferred. HTML form creation experience is preferred

  • Strong communication skills
  • Solid problem-solving and organizational skills

Preferences:

  • Background in clinical data management
  • Skilled in Microsoft Office products

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Sr. Clinical Research Associate

Chapel Hill, NC

(Job Code: 00373) - Apply...

The Senior CRA role is integral to ensuring project success as part of multi-disciplinary teams that are providing scientific, statistical, operations and management support for a large portfolio of NIH-sponsored clinical trials and observational studies in the therapeutic areas of solid organ transplant and autoimmune research . This position will require independent monitoring of clinical trial sites and collaboration with the study teams for site management. The Sr. CRA will be responsible for ensuring that sites operate in compliance with study protocols, Rho SOPs, ICH/GCP guidelines, and Federal Regulations. As a senior member of the operations team the Sr. CRA will be responsible for supporting study team and operations management, providing input into monitoring tool and process development as well as training for newly assigned project CRAs. The Sr. CRA will also;

  • Proactively drive project success, including working closely with Project Coordinators, Managers and Directors
  • Support the management and development of other CRAs
  • Attend and present at meetings and conferences, including Investigator Meetings
  • Provide skilled review of study protocols
  • Work effectively with site staff
  • Contribute to Clinical Operations community initiatives

This position will be based out of the Chapel Hill/RTP office,

The qualified individual will have:

  • Approximately 4 years of on-site monitoring experience
  • BA/BS, preferably in a life science, nursing, pharmacy or related field (RN or MD preferred but not required)
  • Broad range of therapeutic experience
  • Proficient technical/scientific knowledge required for comprehension and execution of clinical protocols.
  • High organizational and logistics skills to ensure effective management of multiple sites and protocols within timeframes and on budget
  • Superior written and verbal communication skills
  • Ability to work in a matrix environment.
  • Demonstrated ability to train, mentor, and lead clinical research staff
  • The ability to constructively interact directly with sponsor personnel
  • Computer literacy, including proficiency in MS Office
  • Expected travel is 65-75%

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Sr. Research Scientist / PI

Chapel Hill, NC

(Job Code: 00370) - Apply...

Plans, organizes, and conducts research in scientific field for use in own work or in project of sponsoring company or institution by performing the following duties.

Essential Duties and Responsibilities include the following. Other duties may be assigned:

  • Participates in decision-making regarding research priorities of company or department, and provides information on feasibility of prospective projects.

  • Develops research plan, designs experiments, outlines research procedures to be followed, and identifies and/or provides training to subordinate personnel to carry out research.

  • Serves as a co-principal investigator and/or statistical investigator on NIH grants and contracts; responsibilities include overall management of the study, designing trials, performing planned and exploratory analyses, writing manuscripts and reports, and consulting with investigators

  • Plans schedule of research according to company’s or contracting organization’s timetable, and establishes daily or weekly routines necessary to meet project timetable.

  • Assists in securing extramural funding as necessary through governmental grants, foundations, institutes, and/or corporate sponsors.

  • Provides expertise in field of research to other department members or faculty.

  • Trains research assistants and graduate students.

  • Prepares reports and papers of completed projects for publication in scientific journals, presentation to regulatory agencies or at conferences, or use in further research activities.

Supervisory Responsibilities: Coordinates supervisory tasks with supervisors within the Biostatistics/Epidemiology Department or in other departments. Education and/or Experience: Ph.D. plus at least 6 years of relevant experience. Degrees must be from fully accredited universities. Training and experience must be in areas related to medical research.

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Statistical Programmer/Analyst (3 positions)

Chapel Hill, NC

(Job Code: 00382) - Apply...

Responsibilities:

Converts data from specifications and statements of problems to computer code. Consults with project team members, systems analysts, other programmers, and end users to gather information about program intent, functions, features, data requirements, input requirements, output requirements, internal and external checks and controls, hardware and operating system environment, and interfaces with other systems. May also serve as a point-person for client interaction.

Basic Qualifications:

  • Must have 5+ years professional experience programming in the SAS language with at least 3 years experience in the pharmaceutical/bio-statistical arena.
  • Strong SAS/Base knowledge with an emphasis on data step programming is a must in addition to an above average understanding of the SAS macro language.
  • Strong data analysis skills are required.
  • Must be competent and comfortable at understanding and modifying pre-existing SAS code, as well as writing SAS code from specs.
  • Must be able to work with minimal oversight as well as to work as a member of a project team.
  • BA/BS in computer science, statistics, or related field

Preferences:

A working knowledge of SAS/STAT and SAS/GRAPH is desired. 2+ years of experience working on statistical programming tasks associated with federal clinical trials.

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Statistical Research Associate

Chapel Hill, NC

(Job Code: 00371) - Apply...

Opportunity for entry-level position with growing contract research organization providing statistical analysis reporting for clinical research. Duties would include generating and validating SAS programs for the production of tables, listings, and figures to be included in clinical study reports.

Specific job duties would include (but are not limited to):

  • Plans and specifies the structure of analysis data sets under the direction of a statistician. This activity can include coordinating the integration of data from various sources and specifying a form compatible with the planned analysis. The process can also include investigating data anomalies and other “data cleaning”.
  • Generate and validate analysis datasets using SAS programs.
  • Draft summary table, figure, and listing specifications for proposed research protocols, under the direction of a statistician.
  • Generate and validate SAS programs for the production of tables, listings, and figures.
  • Modifies and maintains software programs written by others.
  • Writes and maintains documentation of changes to computer code, programs, and specifications.
  • Reviews user and technical documentation written by others to confirm consistency with program operations.
  • Coordinates with other team members about program revisions.

Requirements:

Bachelors degree in Biostatistics or Statistics is ideal. Bachelors degree in a social science with exposure to research methods and statistical analysis is also acceptable. Familiarity with SAS data step programming or SPSS is a must. This individual must also be able to work independently in a team-oriented environment, have a desire to learn new skills, have strong analytical skills, and good written and verbal communication skills.

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Statistical Research Associate (2 positions)

Chapel Hill, NC

(Job Code: 00390) - Apply...

Opportunity for entry-level position with growing contract research organization providing statistical analysis reporting for clinical research. Duties would include generating and validating SAS programs for the production of tables, listings, and figures to be included in clinical study reports.

Specific job duties would include (but are not limited to):

  • Plans and specifies the structure of analysis data sets under the direction of a statistician. This activity can include coordinating the integration of data from various sources and specifying a form compatible with the planned analysis. The process can also include investigating data anomalies and other “data cleaning”.
  • Generate and validate analysis datasets using SAS programs.
  • Draft summary table, figure, and listing specifications for proposed research protocols, under the direction of a statistician.
  • Generate and validate SAS programs for the production of tables, listings, and figures.
  • Modifies and maintains software programs written by others.
  • Writes and maintains documentation of changes to computer code, programs, and specifications.
  • Reviews user and technical documentation written by others to confirm consistency with program operations.
  • Coordinates with other team members about program revisions.

Requirements:

Bachelors degree in Biostatistics or Statistics is ideal. Bachelors degree in a social science with exposure to research methods and statistical analysis is also acceptable. Familiarity with SAS data step programming or SPSS is a must. This individual must also be able to work independently in a team-oriented environment, have a desire to learn new skills, have strong analytical skills, and good written and verbal communication skills.

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Study Coordinator

Chapel Hill, NC

(Job Code: 00379) - Apply...

Summary:

The Study Coordinator provides overall management of a number of clinical studies and is the liaison to the internal study team, clinical centers participating in the trial, third party contractors, industry sponsors and the NIH contact for study-specific issues. Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Coordinates a cross-functional team and communicates with site and sponsor personnel.
  • Oversees development of study materials and assists with the development of protocols, CRFs, informed consent forms, manuals of operations and monitoring plans.
  • Participates in development of project-specific SOPs and study-specific guidelines.
  • Develops and updates study timelines and project plans.
  • Develops and submits materials to IRB for study approval and annual reporting.
  • Oversees the distribution, collection, review and tracking of regulatory documents.
  • Assesses ability of prospective sites to meet protocol guidelines.
  • Prepares routine progress reports for quarterly reports and website display. Summarizes study progress for quarterly and annual reports.
  • Ensures information entered into tracking systems and website displays is accurate and updated on a regular basis.
  • Provides and/or arranges for training of site personnel and clinical monitors.
  • Participates in site monitoring by providing study materials and training to CRAs, reviewing monitoring reports, assisting with resolution of site issues and subsequent corrective action, and attending site visits as needed.
  • Works with the Rho Principal Investigator and Project Director to ensure study is conducted according to contract specifications and budget.
  • Ensures that studies are progressing according to quality standards and regulations.
  • Ensures study documents are properly archived.

Bachelor’s degree (BA or BS) and two or more years related experience required. Knowledge of drug development process and of Federal Regulations governing drug development and reporting requirements, including ICH and GCP requirements preferred.

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Study Coordinator

Chapel Hill, NC

(Job Code: 00385) - Apply...

Summary:

The Study Coordinator provides overall management of a number of clinical studies and is the liaison to the internal study team, clinical centers participating in the trial, third party contractors, industry sponsors and the NIH contact for study-specific issues. Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Coordinates a cross-functional team and communicates with site and sponsor personnel.
  • Oversees development of study materials and assists with the development of protocols, CRFs, informed consent forms, manuals of operations and monitoring plans.
  • Participates in development of project-specific SOPs and study-specific guidelines.
  • Develops and updates study timelines and project plans.
  • Develops and submits materials to IRB for study approval and annual reporting.
  • Oversees the distribution, collection, review and tracking of regulatory documents.
  • Assesses ability of prospective sites to meet protocol guidelines.
  • Prepares routine progress reports for quarterly reports and website display. Summarizes study progress for quarterly and annual reports.
  • Ensures information entered into tracking systems and website displays is accurate and updated on a regular basis.
  • Provides and/or arranges for training of site personnel and clinical monitors.
  • Participates in site monitoring by providing study materials and training to CRAs, reviewing monitoring reports, assisting with resolution of site issues and subsequent corrective action, and attending site visits as needed.
  • Works with the Rho Principal Investigator and Project Director to ensure study is conducted according to contract specifications and budget.
  • Ensures that studies are progressing according to quality standards and regulations.
  • Ensures study documents are properly archived.

Bachelor’s degree (BA or BS) and two or more years related experience required. Knowledge of drug development process and of Federal Regulations governing drug development and reporting requirements, including ICH and GCP requirements preferred.

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Affirmative Action Information

Rho, Inc. is an Equal Opportunity Employer. At Rho, we consider applicants for all positions without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, veteran status or any other legally protected class. Rho is also a Federal contractor. Federal law requires certain Federal contractors and subcontractors to take affirmative action to employ and advance in employment minorities and females and to maintain race, ethnicity and gender information on all persons seeking employment with Rho.

Providing the demographic information requested on the Rho Careers page, is strictly voluntary. All information provided will be kept confidential and declining to provide this information will not subject you to any adverse treatment in the either the application or the hiring process. The information you submit will be used for Federal record-keeping and reporting purposes and only in ways that are not inconsistent with applicable law.

E-VERIFY Statement

Rho participates in E-Verify. We will provide the Social Security Administration, and if necessary, the Department of Homeland Security, with information from each new employee's Form I-9 to confirm work authorization. Please note that we do not use this information to pre-screen job applicants.


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