Ensuring studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures. Identifying, selecting, and monitoring performance of investigational sites for clinical studies. Reviewing key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determining appropriate action in conjunction with study team.

• Coordinate clinical trials for various pharmaceutical companies under the supervision of a physician.• Oversee study conduct at assigned sites• Maintain regulatory documents• Perform nursing duties as designated by protocol• Screen potential subjects and determin eligibility• Conduct informed consent process• Obtain medical histories, vital signs, phlebotomy, specimen processing and shipping• Record and report adverse events• Maintain source documents and case report forms• Conduct monitoring, site-initiation, and close-out visits with clinical research monitors

• Provide overall support for project(s) as directed by Project Manager• Provide support, guidance, and act as a resource to CSSs• Identify areas of concern and growth for CSSs and provide training as necessary• Delegate specific duties to the CSS team• Complete and maintain the Site Management Plan as necessary• Working knowledge of protocol(s) and requirements for assigned project(s)• Contact potential investigator sites in accordance with the project specific feasibility process to determine site interest• Assure timely entry of feasibility results in CTMS and/or applicable tracking mechanism (e.g. supporting Excel file(s)• Recruit prospective investigator sites in accordance with the project specific recruitment plan. Resolve any missing or incomplete entries within CTMS• Prepare and forward regulatory document packets and simplified site contracts to investigators• Receive and review/process completed regulatory documents and completed simplified site contracts from investigators/physicians and forward to the Regulatory Document Specialist (RDS) for final review