What are the responsibilities and job description for the Clinical Research Coordinator (Community Health) position at VIRTUA?
Job 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 which may include quality improvement data and tracking information submitted to clinical trial sponsors and regulatory agencies.
Coordinates visits for pharmaceutical and cooperative group trials. Provides information to Principal Investigators for patients and families regarding research trials participation and assists physicians & patients with informed consent process. Responsible for submitting all documentation and specimens to sponsoring organizations in compliance with protocol specifications.
Liaise with Regulatory Agencies (IRB, NCI, and FDA) for project compliance.
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:
Required Experience: 2-5 years data management clinical research experience, and strong administrative experience. Strong organizational skills 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 /Certification /Licensure: National Institute of Health Human Subjects Protection Certification; CCRP or CCRC certification preferred. Willingness to be trained to perform phlebotomy if needed.