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Clinical Research Coordinator II
3 months ago
Clinic Research Coordinator II
The Clinical Research Coordinator II, 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
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