About the job

Essential Responsibilities and Duties:

• Coordinates patient-related activities for complex and/or multiple studies under supervision, from study startup through close-out.
• Maintains and organizes clinical trial research documentation.
• Monitors study subjects and supports data analysis and reporting.
• Coordinates the timing and collection of study data.
• Identifies, documents, and reports adverse events, protocol deviations, and other unanticipated problems through the appropriate channels.
• Tracks and reports research data to uphold quality and regulatory compliance.
• Completes study-related administrative and regulatory tasks as needed.
• Contributes to protocol development activities.
• Confirms the site receives accurate information and materials from sponsors (e.g., source documents, protocol, scales, supplies, approvals, contacts).
• Explains protocol-specific requirements and expectations to prospective participants and their caregivers.
• Conducts protocol-required safety and efficacy assessments (vital signs, EKGs, blood draws, and other assigned procedures).
• Supports the Clinical Trial Manager (CTM) in overseeing vendors, accounting, regulatory matters, client satisfaction, recruitment, quality, and trial outcomes.
• Assists the CTM with planning, process development, staff training, and team development.
• Takes on additional duties as assigned. The responsibilities above describe the general level and nature of work for this role and are not intended to be all-inclusive.

Education / Experience / Skills:

• Proven experience and demonstrated proficiency as a Clinical Research Coordinator.
• High school diploma or equivalent required; Bachelor's degree preferred.
• CCRC certification preferred.
• 2–3 years of experience in the medical field preferred.
• Working knowledge of federal regulations governing the protection of human research subjects and the conduct of clinical trials.
• Strong leadership and mentorship abilities.
• Skilled at building and maintaining effective working relationships across all levels of the organization, as well as with sponsors and vendors.
• Sound crisis management and problem-solving skills, with the ability to stay calm and effective under pressure.
• Works well both independently and as part of a team.
• Strong verbal and written communication skills.