Site Manager The Site Manager's job is to ensure that quality research is conducted at 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. Also To ensure study enrollment meets or exceeds Sponsors' expectations and 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. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). Responsible for immediate supervision and performance of the assigned site staff under the supervision of the Site Director or Director of Site Operations. 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. It is the responsibility of the Site Manager to make sure all the relevant training is completed prior to performing any applicable tasks on the assigned study. Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow-up on the action items, at their respective sites. Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s). Ensuring clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs, and guidance documents. Ensuring data quality, subject retention, and compliance, timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s). Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations Coaching, counseling, and disciplining the employees as applicable. To develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards. Communicating and effective implementation of strategic goals from senior management to the site team. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Strive to ensure weekly, monthly, and quarterly assigned goals are met for their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings. 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: Bachelor's degree preferred Advanced degree preferred Experience: At least 4 years of clinical research coordinator experience, including 2 years of management experience at a clinical research organization. Credentials: Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred. Knowledge and Skills: Solid teamwork, organizational, interpersonal, and problem-solving skills and attention to detail. Critical Thinking Active Listening Reading Comprehension — Understanding written sentences and paragraphs in work-related documents. Speaking and Writing to communicate effectively as appropriate for the needs of the audience. Ability to multitask, adhere to deadlines, and work both independently and cooperatively with interdisciplinary teams. Strong computer skills in relevant software and related clinical systems are required. Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. 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.
