Program Coordinator (PT) - Department of Pediatrics
The Department of Pediatrics at West Virginia University is seeking applications for a part-time (non-benefits) Program Coordinator. This position examines, evaluates, and investigates conformity with the regulatory aspects of industry and government sponsored clinical trials and investigator initialized clinical research. This includes securing Institutional Review Board (IRB) approval and maintaining all records pertaining to IRB approval and oversight. Performs various duties, such as research, analysis and auditing in support of project IRB submissions to assure compliance,
This position provides program, as well as direct internal and external client support services. Responds to inquiries and independently resolves matters of low to moderate complexity. Responsibilities require some judgment, resourcefulness, and originality, but diverse guides and precedents are usually available to apply or adapt to the circumstances. Work effort has considerable impact on client services, program and project image, with potential legal liabilities.
In order to be successful in the position, the ideal candidate will:
- Oversees all regulatory activities within the Pediatric Research Unit (PRU).
- Coordinates, delegates, and evaluates regulatory operations of the WVU proportion of effort initiatives in conjunction with the Principal Investigators.
- Collaborates daily with the research nursing staff, data managers, and study coordinators.
- Leads efforts to develop, maintain, and revise protocol procedures to ensure accurate, concise compilation of research data.
- Attends study sponsored clinical coordinator meetings to ensure proper management of protocols.
- Works closely with all PRU staff to assure that patient visits are scheduled in accordance with protocol guidelines.
- Collaborates with principal investigators to identify and resolve protocol implementation problems during design period; uses and revises/creates data forms to meet study requirements.
- Educates patients and/or family members, hospital and other university research personnel regarding research study requirements to ensure that all relevant individuals adequately understand study intent and procedures.
- Collaborates with PRU Faculty Advisor and Director to establish regulatory policies for the PRU.
- Oversees and conducts organizational audits performed by monitoring and regulatory agencies.
- Oversees the recruitment of potential protocols for activation from industry sponsored and other sponsoring organizations.
- Oversees the patient recruitment efforts to ensure they comply with protocols.
- Bachelor's degree in an allied health discipline or related field; or an equivalent combination of education and experience. Master's degree is preferred.
- Three (3) years of experience working in a clinical setting and/or experience working in clinical trials
- Working knowledge of regulatory aspects of industry and government sponsored clinical trials. Including IRB regulations.
- Skilled at problem solving.
- Excellent teamwork skills.
- Basic work processing skills and understanding and the ability to handle stress and work under pressure.
- Skilled at using logic and reasoning to identify the strengths and weaknesses of alternative solutions. conclusions or approaches to problems.
- Strong time management skills.
- Computer proficiency, including Microsoft Office.
- Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to manage multiple projects and changing priorities is required.
- Demonstrated ability to work effectively in both cross-functional teams and independently is required.
- Valid driver's license
- After a minimum of 2 years of employment, it will be expected that the incumbent obtain certification as a Research Professional through the Society Clinical Research Associates (SoCRA).
At West Virginia University, we pride ourselves on a tireless endeavor for achievement. We are home to some of the most passionate, innovative minds in the country who push their limits for the sake of progress, constantly moving the world forward. Our students, faculty and staff make this institution one of the best out there, and we are proud to stand as one voice, one university, one WVU. Find out more about your opportunities as a Mountaineer at http://hr.wvu.edu/.
West Virginia University is proud to be an Equal Opportunity employer, and is the recipient of an NSF ADVANCE award for gender equity. The University values diversity among its faculty, staff, and students, and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.Job Posting: Jul 15, 2021
Posting Classification: Non-Classified
Exemption Status: Non-Exempt
Benefits Eligible: No