Clinical Research Coordinator-Full-time-Onsite

About the role

Working under the direction of the Institute for Clinical Research (ICR) and the Principal Investigator (PI), the Clinical Research Coordinator is responsible for the end-to-end coordination and execution of clinical research studies conducted through the ICR. This role serves as the primary operational lead for assigned trials, ensuring studies are conducted in compliance with protocol requirements, Good Clinical Practice (GCP), and institutional and regulatory standards.

Responsibilities

• Human Subjects Protection & Regulatory Compliance: Protect the rights, safety, and welfare of human research participants in accordance with ethical principles, regulatory requirements, and institutional policies. Maintain working knowledge of regulatory, institutional, sponsor, and protocol requirements applicable to assigned studies. Completing IRB required human subjects protection training (in addition to any other sponsor required training).
• Study Feasibility & Start-Up: Evaluate new protocols for feasibility in collaboration with the Principal Investigator, including assessment of patient population, enrollment potential, and operational requirements. Review study protocols and supporting materials (e.g., Investigator’s Brochure, consent forms, data collection tools) to identify safety concerns, workflow challenges, and practical considerations. Assess logistical needs and resource availability, including staffing, space, ancillary services, and departmental support. Prepare and submit regulatory documents to the IRB and manage all start-up-related approvals. Organize and maintain regulatory and study files, ensuring readiness for study initiation and ongoing oversight. Prepare the site for study conduct, including participation in investigator meetings and coordination of sponsor site initiation visits. Create, adapt, or review study-specific source documents as needed.
• Study Operations & Oversight: Train and support all individuals involved in study conduct, including investigators, study staff, and ancillary departments. Collaborate with internal departments (e.g., laboratory, pharmacy, radiology) to ensure protocol-required procedures are executed correctly. Participate in sponsor, institutional, and regulatory audits, including for-cause and routine monitoring activities. Maintain audit-ready study documentation and respond to audit findings as needed.
• Informed Consent Process: Participate in and support the informed consent process in accordance with the IRB-approved protocol. Work with the sponsor and/or IRB on consent language revisions, including coordination of translated consent forms when required. Conduct the informed consent discussion with potential participants or their legally authorized representatives when delegated. Implement amended consent forms promptly and ensure re-consent occurs when required. Ensure informed consent is an ongoing process throughout the duration of the study.

Requirements

• Bachelor's Degree or equivalent clinical research experience required.
• Minimum of 2 years of clinical research experience required. 5+ years of experience preferred.

Qualifications

• Analytical and problem-solving skills – Ability to interpret clinical trial protocols, eligibility criteria, and study data; identify discrepancies, trends, or risks; and escalate issues appropriately.
• Strong organizational and time-management skills – Proven ability to manage multiple studies, competing deadlines, and study visits while maintaining protocol compliance and data integrity.
• Effective collaboration and teamwork – Ability to work productively with investigators, research nurses, sponsors, monitors, IRBs, and ancillary clinical departments to support study execution.
• Professional communication skills (verbal and written) – Clear, accurate, and timely communication with patients, physicians, sponsors, and regulatory bodies, including preparation of study correspondence and documentation.
• Computer and systems proficiency – Experience using clinical research systems and tools (e.g., EDC, CTMS, eRegulatory platforms, Microsoft Office) and ability to learn new systems quickly.
• Judgment and professionalism – Ability to exercise sound judgment, maintain confidentiality, and uphold ethical and regulatory standards in all aspects of research conduct.

Skills

• GRP certification upon hire preferred.
• CCRP - Certified Clinical Research Professional preferred or CCRC - Certified Clinical Research Coordinator preferred.

Benefits

Full-time and part-time employees have access to a comprehensive benefits package designed to support your health, financial security, and quality of life. We offer low-cost medical coverage with generous employer contributions, dental and vision plans, discounted prescriptions, and access to on-site child care. Additional benefits include 401(k) matching, tuition reimbursement, paid time off, flexible spending accounts, legal and voluntary coverage options, life insurance, and free on-site parking.

Pay

$50,032.00 - $67,496.00

Schedule

Full-time and part-time positions available.