Clinical Research Coordinator

Pediatric Specialists Of Virginia - Fairfax, VA

Full-time - Entry Level

Fairfax, VA

Ambulatory Health Care Services

About the position

The Clinical Research Coordinator at Pediatric Specialists of Virginia (PSV) will support the Gastroenterology Clinic by coordinating all aspects of clinical trial implementation. This role involves ensuring compliance with GCP, FDA, and PSV guidelines, managing multiple research trials, and collaborating with the research team to meet study objectives. The position is full-time, located in Fairfax, VA, and focuses on providing high-quality research dedicated to the care of children with gastrointestinal and nutritional disorders.

Responsibilities

• Coordinate all aspects of clinical trial implementation from protocol feasibility through study closure.
• Adhere to GCP, FDA, and PSV guidelines to ensure high-quality research.
• Communicate effectively and collaborate with the research team to meet study and departmental objectives.
• Prepare and submit all regulatory documents to study sponsors and/or IRB prior to initiating research activities.
• Manage multiple trials as established by the research manager.
• Collaborate with the Principal Investigator (PI) and/or sponsor to determine eligibility of subjects.
• Maintain study enrollment as contracted with the sponsor.
• Ensure no protocol violations by verifying subject eligibility and enrollment in research studies.
• Prepare for sponsor monitoring visits by ensuring all case report forms (CRFs) are completed and source documents are available.
• Assure study and regulatory compliance by performing periodic updates to the regulatory binder and reviewing study documentation.
• Respond to audit reports and follow-up requests as needed.
• Manage specimen collection and mailing of specimens to study laboratories.

Requirements

• 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.

Nice-to-haves

• Three years of clinical research experience desired.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short and long-term disability insurance
• 401k plan
• Holidays
• Paid time off
• Fun work environment