Site Manager

Job Description

Job Description

Summary: The Site Manager oversees the daily operations of the clinical research site, maintaining compliance with regulatory requirements, company policies, and Good Clinical Practice (GCP). This position manages site activities, non-dialysis research staff and site operational needs in support of successful trial conduct; included but not limited to monitoring study equipment, environmental controls such as temperature logs and coordinating administrative tasks. The Site Manager serves as the on-site point of contact for staff and visitors, promoting organized workflow and consistent communication across all site functions.

Duties and Responsibilities: TheSite Manager:

• Manages daily site operations in accordance with company policies and regulatory standards.
• Reviews and documents temperature logs, equipment calibration, and facility maintenance related to study requirements.
• Coordinates daily and weekly schedules for site staff to maintain appropriate coverage.
• Assists with study start-up activities, including site initiation, regulatory file preparation, and supply organization.
• Supports Clinical Research Coordinators (CRCs) and Research Assistants (RAs) with study documentation, data entry, and follow-up tasks.
• Reviews source documents and regulatory binders for accuracy and completeness.
• Orders and tracks study supplies, laboratory kits, and investigational products as directed.
• Maintains filing systems for regulatory correspondence, logs, and essential study documents.
• Prepares for audits and inspections, participates in responses, and maintains ongoing readiness for sponsor or regulatory visits.
• Works closely with the non-dialysis research team to maintain protocol compliance, participant safety, and study timelines.
• Communicates regularly with central departments (Regulatory, QA, HR, Finance) to coordinate activities and address operational needs.
• Tracks site performance metrics such as recruitment numbers, retention data, and data entry timelines.
• Conducts temperature checks and documentation for freezers, refrigerators, and other drug storage areas.
• Participates in site meetings, sponsor visits, and internal training sessions.
• Identifies and reports operational issues or process gaps to the VP, Site Operations.
• Occasional travel to company sites, investigator meetings, and/or company meetings.
• Performs other duties as assigned.

This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.

Requirements:

• Bachelor’s degree in a health-related field preferred.
• Minimum 5 years of Management experience
• Minimum 5 years of Site Manager or similar role.
• Prior experience as a lead CRC, regulatory coordinator, or in a site management support role preferred.
• Ability to collect and manage research data accurately.
• Strong organizational, multitasking, and written communication skills.
• Familiarity with documentation review processes in clinical research.
• Proficiency in Microsoft Office, Electronic Data Capture (EDC), and clinical databases.
• Collaborative approach with staff and leadership across departments.

Continuing Education:

• GCP (Good Clinical Practice) – Must renew every 3 years
• IATA (dangerous goods handling) – Must renew every 2 years
• Maintain evidence of completion of all continuing education.

Competency Requirements:

• Leadership & Team Management
• Project Management
• Excellent Communication skills.
• Problem Solving skills.
• Planning /Organizational Skills
• Customer Service Skills
• Computer Competency in Electronic Data Capture

Physical Requirements and/or environmental factors:

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift 20 pounds plus.
• Occasional exposure to human bodily fluids and laboratory materials.
• Travel to sponsor required meetings as needed.