Clinical Research Coordinator

Job Title:

Clinical Research Coordinator - Oncology

Job Description

This role leads the initiation and activation of new oncology clinical trial protocols and coordinates day-to-day study operations across multiple sites. The Clinical Research Coordinator ensures all regulatory, ethical, and contractual requirements are met prior to study activation, supports investigators and research nurses in delivering high-quality, compliant research, and serves as a key liaison between patients, study sponsors, and internal research teams.

Responsibilities

+ Lead and coordinate the initiation and activation of new clinical trial protocols, ensuring all pre-activation requirements are complete.

+ Verify approvals from Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), data collection plans, and finance/contract approvals prior to study activation.

+ Coordinate the preparation of study tools, including study binders, medication diaries, eligibility checklists, calendars, and flow sheets, as required.

+ Use clinical trial management systems and Microsoft Excel and Word to develop and maintain study tools and documentation.

+ Collaborate with the Research Nurse Clinician (RNC) and/or physician to review patients' charts and medical histories to confirm protocol eligibility.

+ Obtain and organize source documents, such as medical record documentation, to support eligibility and study data.

+ Under the direction of the RNC and/or physician, ensure that IRB-approved informed consent is obtained, properly signed, filed in the medical record, and that a copy is provided to the patient.

+ Register consented research patients with study sponsors, including industry partners and cooperative groups, and enter data into the clinical trials database.

+ Maintain complete and accurate research records for all patients enrolled on clinical trials, including consent forms, eligibility documentation, case report forms (CRFs), registration confirmations, and corresponding source documents.

+ Support and track clinical trials conducted at centers, community physicians' offices, and hospitals, ensuring consistency and compliance across locations.

+ Collaborate with the RNC and physician to assist with grading adverse events using the most recent National Cancer Institute (NCI) common toxicity criteria or protocol-specific grading scales.

+ Complete Serious/Unexpected Adverse Event (SAE) forms for internal and multicenter serious or unexpected adverse events in accordance with sponsor, federal, and institutional requirements.

+ Ensure ongoing maintenance and organization of research records for all assigned trials and subjects, including updates to consents, eligibility, CRFs, and source documents.

+ Generate and provide regular reports from the clinical trials database to tumor study group members and Principal Investigators on all assigned studies.

+ Understand and anticipate the needs of study sponsors, acting as a primary study liaison and maintaining professional, responsive communication.

+ Schedule and coordinate sponsor monitoring visits and conference calls, ensuring all required documentation and data are available and accurate.

+ Provide accurate, timely, and well-supported responses to sponsor queries and data requests.

+ In collaboration with the RNC, ensure that all personnel, including investigators, conduct studies according to the treatment plan, protocol requirements, and Good Clinical Practice (GCP) guidelines.

+ Recruit and screen patients for clinical trials, coordinating study visits and procedures in alignment with protocol timelines.

+ Communicate clearly and compassionately with patients to explain study procedures, address questions, and support their participation throughout the trial.

Essential Skills

+ Bachelor's degree required.

+ One to three years of relevant clinical research experience, preferably as a Clinical Research Coordinator.

+ Experience in oncology clinical research, including screening and coordination of study participants.

+ Demonstrated experience obtaining or coordinating informed consent in a clinical research setting.

+ Experience recruiting,…