Clinical Research Coordinator I (3932)

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: 1. Sponsor-provided and IRB-approved Protocol Training 2. All relevant Protocol Amendments Training 3. Any study-specific Manuals Training, as applicable 4. 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.