Summary:
Coordinates and participates in clinical research studies conducted by principal investigators. Acts as a liaison for clinical investigators and IRB coordinators to ensure compliance of general and study specific regulatory processes for reporting to various regulatory agencies.
Position Responsibilities:
• Conducts complete, timely data management activities as required by protocol to ensure the submission of accurate information to clinical trial sponsors and regulatory agencies.
• Responsible for submitting all documentation and specimens to sponsoring organizations in compliance with protocol specifications.
•Assist physicians to document and submit patient adverse events to appropriate authorities.
• Coordinates audits, monitoring visits, initiation visits and other site visits as needed.
• Coordinate patient study visits including scheduling, procedures, administering the informed consent process when appropriate, and data collection.

• Participates in meetings to facilitate research projects (IRB meetings, Research Review Committee meetings, etc). Ensures appropriate studies are available at Virtua and educate staff of regulatory changes or updates.

Position Qualifications Required / Experience Required:
Excellent communication and interpersonal skills required to communicate with patients, families, physicians and nurses.
Required Education:
HS graduate; Associate/bachelor’s degree preferred. 
Training/Certifications/Licensure:
National Institute of Health Human Subjects Protection Certification required upon hire; CCRP or CCRC certification preferred; CCRP or CCRC required within 18 months of hire or within 6 months of eligibility.

Strongly prefer Phlebotomy certification or willing to get cert while employed.