Clinical Research Coordinator - Pediatric Specialists of Virginia
Fairfax, VA 22031
About the Job
PSV has an exciting employment opportunity for a Clinical Research Coordinator, supporting PSV’s Gastroenterology Clinic.This role is working in our Fairfax, VA location andis working Full-Time Day Shift 40hrs/week.
PSV offers a comprehensive benefits package: including medical, dental, vision, life, short and long-term disability insurance, 401k plan, holidays, paid time off and a fun work environment. Come join our team! All qualified applicants will receive consideration for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or status as an individual with a disability.
The Pediatric Specialists of Virginia (PSV) Gastroenterology, Hepatology, and Nutrition team are dedicated to the care of infants, children, and adolescents with stomach, digestive, liver, and nutritional disorders. Our specialists are dedicated to caring only for children, which means we are also specialists in addressing the unique needs of children and families living with these disorders.
- Has detailed knowledge of all components of the research procedures and the research study protocol by creation of study packets and checklists, educating staff and other departments as needed.
- Completes and submits all regulatory documents to study sponsor and or IRB, as required, prior to any research activities being initiated until study completion.
- Prepares research applications and follows up on review and approval of same, addressing any concerns.
- Manages multiple trials as established by research manager. Collaborates with PI and/or sponsor to determine eligibility when appropriate. Maintains study enrollment as contracted with sponsor. Ensures no protocol violations by appropriate subject eligibility and enrollment in a research study and completion of all tests/procedures within the timeframe indicated in the protocol.
- Prepares for a sponsor monitoring visit by assuring all CRF’s are completed, source documents are available and regulator documents are up-to-date.
- Assures study and regulatory compliance by performing periodic updates to the regulatory binder and review of study documentation and appropriate reporting.
- Consistently ensures regulatory readiness for external audit visits. Responds to audit report and follow up requests as needed.
- Performs protocol and general research procedures as needed.
- Manages specimen collection and mailing of specimens to study laboratories.
- Minimum of one (1) year of clinical research experience required.
- CRA/CCRP certification.
- Excellent written and verbal communication skills.
- Knowledge of research methodology.
- All employees must pass an employment TB, drug and physical exam.
- Three years of clinical research experience desired.