Clinical Research Coordinator

Job Title:

Clinical Research Coordinator

Job Description

The Clinical Research Coordinator coordinates and oversees the clinical operations of assigned clinical trials, ensuring compliant study conduct in alignment with all relevant local, federal, and state regulations and institutional policies. Working under the general supervision of the principal investigator, this role serves as a central liaison among investigators, clinical research nurses, regulatory specialists, sponsors, and study participants. The coordinator supports feasibility assessment, protocol implementation, subject enrollment, data integrity, and financial compliance, contributing directly to high-quality patient care and successful research outcomes.

Responsibilities

* Act as liaison between principal investigators, sub-investigators, clinical research nurses, and regulatory specialists on all regulatory issues and protocol changes.

* Collaborate with the principal investigator, clinical team, and research staff to review proposed studies for feasibility and evaluate potential competition with existing protocols before submission.

* Review studies with the principal investigator and/or clinical research nurses to develop a budget outlining standard-of-care versus research-related costs.

* Finalize budget drafts in collaboration with the budget coordinator and clinical research finance to ensure appropriate billing for clinical trial activities.

* Review proposed study protocols to assess sample collection processes, data management plans, and potential subject risks.

* Oversee subject enrollment to ensure informed consent is properly obtained, documented, and maintained according to regulatory and institutional requirements.

* Coordinate research activities including scheduling laboratory tests, radiology procedures, and other medical examinations required by study protocols.

* Work with the study team to draft and create study-specific orders, billing templates, and study calendars as necessary.

* Schedule subjects for appointments, procedures, and inpatient stays in accordance with protocol requirements.

* Monitor all study activities to ensure strict compliance with study protocols and all applicable local, federal, and state regulations, as well as institutional policies and Standard Operating Procedures.

* Register protocol patients with appropriate statistical centers or cooperative groups as required by the study.

* Track enrollment status of subjects and document dropout information, including reasons for withdrawal and subject contact efforts.

* Serve as the principal investigator's representative when appropriate, including communicating with sponsors, institutional review boards (IRBs), and other medical personnel.

* Maintain accurate, complete, and up-to-date records for each protocol and each patient in the clinical trial management system and any other required systems, in collaboration with clinical research nurses.

* Work closely with clinical research finance teams to ensure that study-related clinical trial activities are billed correctly and in accordance with the study budget.

* Schedule, coordinate, and prepare for sponsor monitoring visits, ensuring all supporting documentation and records are adequate and available.

* Meet with sponsor monitors during site visits, address findings, and resolve issues identified during monitoring.

* Maintain ongoing contact with sponsors to schedule and coordinate site visits and respond to questions regarding incomplete or missing data.

* Ensure compliant maintenance of all required records of study activity, including case report forms, drug dispensation records, and regulatory documentation.

* Oversee and direct the requisition, collection, labeling, storage, and shipment of specimens according to protocol and regulatory guidelines.

* Prepare for and participate in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups.

* Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, IRB submissions, and progress reports.

* Identify protocol-related problems, inform investigators of issues, and assist in resolving problems, including contributing to protocol revisions when needed.

* Organize and manage space for study equipment and supplies to ensure efficient and compliant study operations.

* Participate in the development of study protocols, including guidelines for administration procedures and data collection processes.

* Contact outside health care providers and communicate with subjects to obtain follow-up information and ensure accurate long-term data collection.

* Review relevant scientific literature, participate in continuing education, and attend conferences or seminars to maintain current knowledge of clinical research practices and issues.

* Collaborate with investigators to prepare presentations and reports summarizing clinical study procedures, results, and outcomes.

* Support clinical operations and…