Clinical Research Coordinator

Key Performance Areas

• KPA 1 – Study Start-Up, Regulatory & Site Initiation: Supports study feasibility, regulatory submissions, and study initiation activities to ensure compliance with protocols, regulatory requirements, and institutional policies.
• KPA 2 – Patient Recruitment, Screening & Enrollment: Recruits, screens, and enrolls patients in accordance with study protocols, reviews eligibility criteria, and conducts interviews to assess subject ability and willingness to complete study procedures.
• KPA 3 – Clinical Trial Coordination & Patient Care Activities: Coordinates study visits, performs clinical procedures, ensures protocol compliance, processes specimens, and prepares and ships study-required specimens per protocol.
• KPA 4 – Data Management, Documentation & Monitoring Support: Maintains accurate study documentation, abstracts data, resolves data queries, schedules sponsor monitoring visits, and prepares case report forms and source documents for sponsor and audit review.
• KPA 5 – Research Program Support, Education & Administrative Support: Supports research department operations, educates and trains, assists in budgeting support, and maintains professional communication with internal and external customers.

Position Qualifications

• Education: Degree in the life sciences or health sciences such as Registered Nurse (R.N.), Doctor in Philosophy (Ph.D.), Medical Doctorate (M.D.), or other related degree.
• Minimum Relevant Experience: 2 or more years of clinical research experience.
• Certifications/Licenses: Continuing education participation is expected, and research certification through a recognized national organization (SOCRA, ACRP) is encouraged. NIH protection of Human subjects online course will be required annually. IATA training will be required every 2 years.
• Travel: 0 - 25%