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Clinical Research Coordinator I
2 weeks ago
Clinical Research Coordinator I
The Clinical Research Coordinator I, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.
Duties & Responsibilities:
- Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
- Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
- a. Sponsor-provided and IRB-approved Protocol Training
- b. All relevant Protocol Amendments Training
- c. Any study-specific Manuals Training, as applicable
- d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
- Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
- Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
- Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
- Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
- Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.
- Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.
- Submitting required administrative paperwork per company timelines.
- Participating in subject recruitment and retention efforts.
- Engaging with Research Participants and understanding their concerns.
- Any other matters, as assigned by management.
Knowledge & Experience:
Education:
- High School Diploma or equivalent required
- Bachelor's degree a plus
- Foreign Medical Graduates preferred
- At least one years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.
- At least two years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting
- ACRP or equivalent certification is preferred
- Registered Medical Assistant certification or equivalent is preferred
- Knowledge and Skills:
- Be an energetic, go-getter who is detail-oriented and can multi-task.
- Be goals-driven while continuously maintaining quality.
- Bilingual in Spanish is preferred
