Required Education:
Required Experience:
- 2 years as CRC is required.
Required Language:
- Bi-lingual English/Spanish preferred.
Job Type: Full-time/Part - time
ESSENTIAL FUNCTIONS:
- Supports enrolling participants on to clinical trials through recruitment, screening, enrollment and follow-up according to protocol requirements.
- Responsible for working with the principal investigator to meet or exceed study enrollment.
- Reviews the study design and inclusion/exclusion criteria with physician and patient.
- Ensures the protection of study participants by verifying informed consent procedures and adheres to protocol requirements/compliance.
- Ensures the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitors data for missing or implausible data.
- Ensures the adequate and accurate records are maintained for inspecting.
- Creates study specific tools for source documentation when not provided by a sponsor.
- Collects and compiles and enters data into study specific CRFs or electronic data capture (EDC) systems.
- Generates and tracks drug or device shipments and supplies as needed.
- Reports and follow-up on serious adverse events as necessary.
- Implements study-specific communications.
- Ensures timely adherence to protocol requirements.
- Responsible for completion of all required training and documentation according to site work guidelines.
- Ensures timely and accurate data collection.
- Maintains accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, drug dispensing logs, device utilization logs, subject logs, and study-related communications.
- Tract and report adverse events, serious adverse events, protocol waivers, deviations, and violations.
- Attends study-specific on-site meetings, Investigator meetings, and conference calls as required or directed by the sponsor.
- Assists sponsor and US FDA audit teams as needed.
- Maintains patient confidentiality according to ethical and legal requirements.
- Assists in providing research coverage for clinics as needed.
- To perform miscellaneous job-related duties as assigned
Job Type: Full-time
Required education:
Required experience:
- Healthcare: 2 year
- Clinical Research: 2 year
- Research: 2 year
Job Type: Part-time
Pay: $20.00 - $30.00 per hour
Education:
Experience:
- Research: 2 years (Preferred)
License/Certification:
- CCRC certified/eligible. (Preferred)
Location:
Work Location: In person
