Job Summary:
Coordinate and manage clinical trials to ensure compliance with protocols, regulations, and institutional policies, supporting participant safety and study integrity.
Key Responsibilities:
- Facilitate site initiation and sponsor-required training for clinical protocols.
- Dispense study medications and coordinate with pharmacy staff as needed.
- Process and ship lab specimens in compliance with federal regulations.
- Conduct informed consent processes, ensuring proper documentation and compliance.
- Schedule and oversee study visits, tests, and procedures per protocol requirements.
- Accurately collect and report data, maintaining research subject charts and source documents.
- Perform or coordinate clinical procedures (e.g., blood draws, ECGs) with appropriate training.
- Report adverse events, protocol deviations, and violations to study sponsors and IRBs.
- Prepare and submit regulatory documents, including IRB applications and consent forms.
- Support participant recruitment, screening, enrollment, and retention.
- Serve as a liaison between participants, investigators, sponsors, and regulatory bodies.
- Assist in sponsor monitoring visits and audits, resolving findings promptly.
Qualifications:
- 4+ years as a Clinical Research Coordinator
- Oncology/ Cardiology experience preferred
- Phlebotomy Certification preferred
- Knowledge of clinical research protocols, GCP, and FDA regulations.
- Strong organizational, communication, and multitasking skills.
- Experience with clinical procedures and data management preferred.
This role supports advancing research by ensuring high standards of protocol adherence and participant care.
