Clinical Research Coordinator

About the role

This role supports complex oncology clinical trials from study start-up through close-out, serving as a primary contact for research participants, sponsors, and regulatory agencies. You will coordinate patient-facing activities, manage study data and documentation, and ensure strict compliance with protocols and regulatory requirements in a fast-paced academic research environment.

Responsibilities

• Serve as the primary contact for research participants, sponsors, and regulatory agencies throughout the life cycle of oncology clinical trials.
• Coordinate clinical research studies from start-up through close-out, ensuring all operational, regulatory, and data-related activities run smoothly.
• Determine participant eligibility according to study protocols and obtain informed consent in alignment with ethical and regulatory standards.
• Affiliate with developing and implementing effective participant recruitment strategies for oncology clinical trials.
• Capture and manage patient and laboratory data for clinical research projects, maintaining accurate and timely records.
• Manage research project databases, including building and maintaining electronic data capture systems, developing flow sheets, and creating study-related documents.
• Complete study documents and case report forms accurately and on time, including entry into electronic data capture (EDC) systems.
• Ensure compliance with research protocols by reviewing and auditing case report forms for completeness and accuracy against source documents.
• Prepare and submit regulatory documents, including initial submissions and amendments, and ensure Institutional Review Board (IRB) renewals are completed on schedule.
• Assemble study kits for study visits, ensuring all required materials and documents are prepared in advance.
• Monitor scheduling of study procedures and related charges, coordinating with clinical teams to align visits and tests with protocol requirements.
• Cook up and organize study documents and files, maintaining regulatory binders and essential documents in accordance with institutional and regulatory standards.
• Attend monitoring meetings with sponsors and contract research organizations, acting as the primary study contact and addressing questions related to study conduct and documentation.
• Monitor study expenditures and adherence to study budgets, collaborating with finance and management staff to resolve billing issues.
• Interact regularly with the principal investigator to review study progress, ensure patient safety, and confirm adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files and systems, in line with institutional and regulatory requirements.
• Participate in monitoring visits and regulatory audits, providing requested documentation and supporting responses to findings.
• Perform chart reviews and pre-screen patients for eligibility, documenting findings and communicating with the study team.
• Work directly with patients in a hands-on capacity as part of gastrointestinal (GI) and oncology research activities, providing clear explanations of procedures and supporting a positive study experience.
• Adapt quickly to changing priorities and study needs in a fast-paced environment, shifting focus as required to meet timelines and sponsor expectations.
• Collaborate closely with multidisciplinary team members, contributing to a supportive and cooperative research environment.

Requirements

• Minimum of 2 years of experience as a Clinical Research Coordinator (CRC), preferably with complex clinical trials.
• Strong background in clinical research, with demonstrated experience coordinating oncology treatment trials.
• Hands-on experience working directly with patients in a clinical research setting, including GI and oncology populations.
• Experience with complex clinical trials, including multi-step protocols and intensive monitoring requirements.
• Proficiency with electronic data capture (EDC) systems for entering and managing study data.
• Experience performing chart reviews and pre-screening patients for clinical trial eligibility.
• Demonstrated ability to ensure compliance with research protocols and regulatory requirements, including IRB processes.
• Proven ability to manage research databases, case report forms, and study documentation accurately and efficiently.
• Comfort working in a fast-paced environment and ability to change gears quickly based on evolving study needs.
• Strong organizational skills with the ability to manage multiple studies and tasks simultaneously.
• Collaborative working style, with the ability to build positive relationships with investigators, coordinators, and other team members.
• Excellent attention to detail and accuracy in data entry, documentation, and audit preparation.
• Strong written and verbal communication skills for interacting with participants, sponsors, and regulatory personnel.

Additional Skills & Qualifications

• Experience coordinating gastrointestinal (GI) research studies or related subspecialty trials.
• Prior experience working within a large academic or teaching hospital research environment.
• Familiarity with budgeting processes for clinical trials and basic financial tracking related to study expenditures.
• Experience preparing for and participating in sponsor monitoring visits and regulatory audits.
• Comfort assembling study kits and coordinating logistics for complex study visits.
• Ability to work independently while maintaining regular communication with principal investigators and study teams.
• Interest in contributing to cutting-edge oncology research conducted at a renowned academic institution.