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- Study Coordination:
- Coordinate and oversee the planning and execution of clinical research studies per protocols and regulatory requirements.
- Work closely with principal investigators and other study team members to ensure the successful implementation of research projects.
- Regulatory Compliance:
- Ensure adherence to regulatory standards and guidelines, including but not limited to FDA regulations, ICH/GCP guidelines, and institutional policies.
- Prepare and submit regulatory documents for study approval and maintain accurate and up-to-date regulatory files.
- Participant Recruitment and Informed Consent:
- Recruit and screen eligible participants for clinical trials.
- Obtain informed consent from study participants and maintain proper documentation.
- Data Collection and Management:
- Collect, record, and manage study data accurately and efficiently.
- Implement data quality control procedures and ensure data integrity throughout the study.
- Communication and Collaboration:
- Serve as the primary point of contact for study participants and liaise with interdisciplinary team members, including physicians, nurses, and laboratory personnel.
- Communicate regularly with sponsors, monitors, and regulatory authorities as needed.
- Training and Development:
- Provide training to research staff and ensure ongoing education on study protocols, procedures, and regulatory requirements.
- Must have prior experience as a Clinical Research Coordinator in a healthcare or research setting (3+ years)
- Must be Bilingual; Spanish
- Must be certified in phlebotomy
Clinical Research Coordinator - California, United States - SQRL
Description
This role will be onsite in Covina, CA
Responsibilities:
Qualifications: