Site Development & Integration Coordinator

Site Development & Integration Coordinator The Site Development & Integration Coordinator 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. DUTIES & RESPONSIBILITIES Completing all the relevant training prior to study-start and on a continued basis in a timely manner Complete and implement Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training or study-specific manual trainings 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 Complete data reviews to ensure the highest standards of data integrity Conduct training for site and SDI personnel Sample processing, including PBMC samples 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: 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 Credentials: ACRP or equivalent certification is preferred Registered Medical Assistant certification or equivalent is preferred DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification 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 Flexibility with scheduling, including travel (50%) when required