Job Description
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:
- 2+ years as a Clinical Research Coordinator/Nurse
- Oncology experience required
- BLS Certification required
- Phlebotomy Certification preferred
- Knowledge of clinical research protocols, GCP, and FDA regulations.
Details:
Location: Santa Maria, CA
Pay: $35/hr-$45/hr (Dependent on background and years of experience)
Hours: Monday - Friday; Normal Business Hours; Onsite 5 Days a Week
Job Tags
Monday to Friday,