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.