Clinical Trial Specialist
2 days ago
New Brunswick
Job Description Job Title: Clinical Trial Specialist The Clinical Trial Specialist coordinates and supports the full lifecycle of oncology clinical trials, from protocol initiation and activation through ongoing conduct and documentation. This role ensures that all regulatory, ethical, and operational requirements are met, while working closely with research nurses, physicians, and study sponsors to deliver high-quality, compliant research that advances cancer care. 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 to support efficient and accurate trial conduct., • Use clinical trial management systems and software such as Excel and Word to develop and maintain study tools, tracking documents, and trial-related materials., • Collaborate with the Research Nurse Clinician and/or physician to review patients’ charts and medical histories to confirm protocol eligibility and obtain required source documents and medical record documentation., • Under the direction of the Research Nurse Clinician and/or physician, verify that the IRB-approved informed consent form has been properly obtained, signed, filed in the medical record, and that a copy has been provided to the patient., • Register consented research patients with study sponsors, including industry sponsors and cooperative groups, and enter patient and study 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, registration confirmations, and corresponding source documents., • Support trial activity across multiple locations, including main centers, investigator-initiated trial sites, community physicians’ offices, and hospitals, ensuring Essential Skills • Two to three years of relevant clinical research experience, preferably in a Clinical Research Coordinator or similar role., • Bachelor’s degree required., • Experience in clinical research, with strong familiarity with clinical trial operations, patient screening, enrollment, and coordination., • Demonstrated experience working with oncology clinical trials or cancer patients in a research setting., • Hands-on experience with informed consent processes, including supporting patients through consent and ensuring proper documentation., • Ability to manage and maintain source documents, case report forms, and other essential clinical trial documentation in compliance with regulatory standards., • Proficiency with computer software programs such as Excel, Word, and, where applicable, database tools such as Access., • Comfort and skill in communicating directly with patients, including discussing study participation and addressing questions or concerns., • Strong attention to detail and accuracy in data entry, documentation, and record maintenance., • Excellent organizational skills, with the ability to manage multiple studies, tasks, and deadlines simultaneously., • Effective written and verbal communication skills to interact with investigators, nurses, sponsors, and other stakeholders., • Ability to work within Good Clinical Practice guidelines and adhere to institutional and regulatory requirements for clinical research. Job Type & Location This is a Contract to Hire position based out of New Brunswick, NJ. Pay and Benefits The pay range for this position is $35.00 - $38.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in New Brunswick,NJ. Application Deadline This position is anticipated to close on May 29, 2026. 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