Clinical Research Coordinator

Associate Clinical Research Coordinator (Contractor)

The Associate Clinical Research Coordinator contractor supports clinical research operations by coordinating non-therapeutic clinical research protocols, assisting with participant-facing activities, and ensuring accurate study documentation in a highly regulated environment. Working under the direction of a principal investigator, supervisor, and other research staff, this role helps facilitate efficient, compliant, and patient-centered execution of clinical studies while interacting with multiple departments, research participants, other research centers, and sponsoring organizations.

Responsibilities

• Coordinate non-therapeutic clinical research protocols (such as minimal risk, survey, and chart review studies) under the direction of the principal investigator and/or supervisor, in full compliance with regulatory requirements and institutional guidelines.
• Assist with complex interventional or therapeutic studies that involve greater than minimal risk, following direction from staff while not holding overall responsibility for these protocols.
• Recruit, screen, and enroll research participants, ensuring they meet eligibility criteria and understand study requirements and expectations.
• Schedule research participants for study visits, procedures, and follow-up appointments, and coordinate related logistics such as blood draw scheduling and use of clinical research facilities.
• Respond to patient and participant communications in a timely, professional manner, addressing questions, concerns, and scheduling needs.
• Coordinate and monitor research activities and participant involvement throughout the study, tracking visit completion and protocol adherence.
• Recognize adverse events, protocol deviations, and other unanticipated problems, and promptly report them according to institutional and regulatory requirements.
• Collect, abstract, and enter research data accurately and consistently, maintaining high standards of data quality and integrity.
• Support kit management and specimen-related processes as needed, including organization and tracking of study materials.
• Perform administrative and regulatory tasks related to assigned studies, which may include maintaining study files, preparing documentation, and assisting with compliance activities.
• Participate in protocol development and maintenance activities, including editing and amending protocol documents, proofing content, and ensuring alignment with institutional and federal standards.
• Coordinate protocol logistics, such as preparing data collection tools (e.g., booklets) and arranging use of clinical research units or other facilities.
• Prepare and submit materials to the Institutional Review Board (IRB) and assist with ongoing IRB communications and status updates.
• Communicate with study sites, internal stakeholders, and external agencies or sponsors regarding protocol status changes and operational updates.
• Collaborate effectively with investigators, research staff, and personnel across departments to resolve study-related issues and promote efficient study conduct.
• Demonstrate strong service excellence while performing repetitive tasks, maintaining accuracy, consistency, and a positive participant experience.
• Maintain clear, organized research documentation and records to support audits, monitoring visits, and regulatory review.
• Travel occasionally as needed for study-related activities, meetings, or training, as assigned.

Essential Skills

• Ability to coordinate clinical research protocols in accordance with regulatory laws and institutional guidelines.
• Experience with research participant screening, recruitment, and enrollment in a clinical or related setting.
• Proficiency in research data collection, abstraction, and data entry with strong attention to detail and data accuracy.
• Comfort working in a regulated environment with adherence to policies, procedures, and compliance standards.
• Strong organizational skills to manage scheduling, documentation, and multiple concurrent tasks or studies.
• Effective written and verbal communication skills in English to interact with research participants, investigators, and internal and external stakeholders.
• Ability to recognize and appropriately report adverse events, protocol deviations, and unanticipated problems.
• Customer service or patient-facing experience in healthcare or a related field, demonstrating professionalism and service excellence.
• High school diploma with at least three (3) years of experience…