The West Virginia University Research Corporation is seeking applications for a Research Coordinator with the School of Medicine. This position will provide administrative oversight in the development, coordination, monitoring and implementation of strategies essential to the successful performance of clinical trials within the WVU School of Medicine.
In order to be successful in this position, the ideal candidate wil:
- Prepares IRB submissions and maintains current IRB documentation for each study in compliance with all IRB and other regulatory policies and procedures.
- Creates standard operating procedures manuals for each study.
- Establishes and performs protocol procedures to ensure participant safety and accurate compilation of research data.
- Holds study start-up meeting with all key team members (principal investigator, co-investigator(s), and appropriate regulatory, laboratory, biorepository and research pharmacy staff.
- Initiates study; recruits and obtains written informed consent from all participants; schedules and conducts study-mandated visits; creates, uses and revises data forms to meet study requirements as necessary; ensures accurate data collection and documentation in a timely manner; participates in data quality assurance activities; schedules external monitor visits and prepares all documents for review in advance of the visit; responds to external monitor requests; and follows all award closeout procedures.
- Attends study-sponsored research coordinator meetings to ensure compliance with protocol.
- Collaborates with principal investigator(s) to identify and resolve protocol implementation issues during both the study development and study conduct periods.
- Participates in audits performed by sponsor or sponsor’s designee and regulatory authorities including the WVU IRB and the FDA.
- Participates in patient recruitment efforts and assures that patient visits are scheduled in accordance with protocol guidelines: consents patients/participants, collects demographic information, acts as project liaison among study investigators, staff, and patients/participants
- Educates patients and/or family members, hospital and other WVU research personnel regarding study requirements to ensure that all relevant individuals understand the study intent and procedures.
- Collaborates daily with research nursing staff, data managers and study coordinators.
- Acts as project liaison among study investigators, staff, and patients/participants.
- Manages multiple projects / protocols concurrently in a dynamic environment.
- Contributes to application process for research grants/contracts to support departmental studies.
- Bachelor's degree in an allied health discipline or related field, RN licensure will be considered. Master's degree preferred.
- Three (3) years of experience working in a clinical setting and/or experience working in clinical trials or an equivalent combination of education and experience.
- Excellent time and project management skills.
- Excellent customer service skills, and the ability to effectively communicate with a variety of audiences, including, but not limited to: patients and families, physicians and internal staff members, regulatory and monitoring agency personnel, and study sponsor representatives.
- Must possess analytical and management skills to coordinate a wide range of duties associated with the successful development, implementation, and reporting of research studies.
- Ability to read and interpret study protocols, regulatory and study compliance documents.
- Effective communications skills, both written and verbal.
- Experienced in phlebotomy or willingness to acquire phlebotomy skills.
- Valid driver's license.
- CITI (Collaborative Institutional Training Initiative) training and Good Clinical Practice Training within 15 days of hire.