Clinical Trial Coordinator

Job Title:

Clinical Trial Specialist

Job Description

The Clinical Trial Specialist coordinates and supports all aspects of clinical research studies from initiation through activation and ongoing conduct. This role focuses on oncology clinical trials and involves preparing study tools, managing regulatory and sponsor requirements, maintaining accurate research records, and supporting patient screening, enrollment, and follow-up in close collaboration with research nurses, physicians, and other clinical research professionals.

Responsibilities

+ Coordinate the initiation and activation of new clinical trial protocols, ensuring all required approvals are in place before study activation, including Scientific Review Board, Institutional Review Board, Human Research Oversight Committee, data collection plans, and finance/contract approvals.

+ Prepare and organize study tools such as study binders, medication diaries, eligibility checklists, calendars, and flow sheets as required for each protocol.

+ Use Oncore, Excel, and Word to develop and maintain study tools, including eligibility checklists, medication diaries, calendars, and flow sheets tailored to specific trials.

+ In collaboration with the Research Nurse Clinician and/or physician, review patients' charts and medical histories to confirm protocol eligibility and obtain necessary source documents from the medical record.

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

+ Register consented research patients with the appropriate study sponsors, including industry partners and cooperative groups, and enter all required information into the Oncore clinical trials database.

+ Maintain complete and accurate research records for all enrolled patients, including consent forms, eligibility documentation, case report forms, registration confirmations, and corresponding source documents across multiple clinical locations.

+ Support and coordinate patient screening, recruitment, and enrollment activities for assigned clinical trials, ensuring adherence to protocol-specific inclusion and exclusion criteria.

+ Assist, in collaboration with the Research Nurse Clinician and physician, with grading adverse events using the most recent National Cancer Institute common toxicity criteria or protocol-specific grading scales.

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

+ Ensure that all research records remain up to date and audit-ready for all patients enrolled on clinical trials, including those at main centers, community physician offices, and affiliated hospitals.

+ Generate and provide regular reports from Oncore to tumor study group members and Principal Investigators on the status of assigned studies and enrolled subjects.

+ Serve as a primary liaison with study sponsors, schedule monitoring visits and conference calls, and provide accurate and timely responses to sponsor queries.

+ Understand and anticipate the needs of study sponsors to facilitate efficient study conduct and strong collaborative relationships.

+ In collaboration with the Research Nurse Clinician, help ensure that all personnel involved in the study, including investigators, conduct the trial in accordance with the protocol, Good Clinical Practice guidelines, and institutional policies.

+ Communicate clearly and professionally with patients, clinical teams, and study stakeholders to support patient understanding, adherence, and a positive trial experience.

Essential Skills

+ One to three years of relevant clinical research experience, preferably in a clinical research coordinator or similar role.

+ Hands-on experience with clinical research coordination, including patient screening, recruitment, and enrollment.

+ Experience working in oncology clinical research or strong interest in oncology trials.

+ Proficiency with computer software programs such as Excel and Word, with the ability to create and manage study tools and reports.

+ Ability to work with clinical research databases, including entering and maintaining accurate data (experience with Oncore is highly valuable).

+ Strong understanding of informed consent processes and comfort communicating study procedures and requirements to patients.

+ Ability to review medical charts and source documents to confirm eligibility and support accurate data collection.

+ Solid organizational skills with the ability to manage multiple studies, timelines, and priorities simultaneously.

+ Excellent written and verbal communication skills to interact effectively with patients, clinical staff, and study sponsors.

+ Strong attention to detail and accuracy in documentation, data entry, and record maintenance.

+ Commitment to high standards of…