Clinical Research Coordinator I (4171)

The Clinical Research Coordinator I will work at site to help 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:

Sponsor-provided and IRB-approved Protocol Training

- All relevant Protocol Amendments Training

- Any study-specific Manuals Training, as applicable

- 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.

- Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives

- Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent

- Facilitate effective communication between patients, healthcare providers, and research staff

- 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

Experience:

- 1+ years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.

- 2+ years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting

Credentials:

- 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.

- Proficient communication and comprehension skills both verbal and written in the English language are required.

- Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.