Clinical Trial Specialist

This Clinical Trial Specialist role offers the opportunity to contribute to cutting-edge oncology research within a National Cancer Institute designated Comprehensive Cancer Center. The position supports advanced, comprehensive cancer care for adults and children by coordinating clinical trials that translate scientific discoveries into clinical practice and support education and outreach in cancer prevention, detection, and treatment.

Responsibilities

+ Coordinate the initiation and activation of new clinical trial protocols, ensuring all required approvals from the Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), data collection plans, and finance/contract teams are in place prior to study activation.

+ Prepare and organize study tools, including study binders, medication diaries, eligibility checklists, calendars, and flow sheets, to support efficient and compliant study conduct.

+ Use clinical trial management systems and software such as Excel and Word to develop and maintain study tools, documentation, and tracking mechanisms.

+ Collaborate with the Research Nurse Clinician (RNC) and physicians to review patients charts and medical histories, confirm protocol eligibility, and obtain necessary source documents and medical record documentation.

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

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

+ Maintain complete and accurate research records for all patients enrolled in clinical trials, including patient consent forms, eligibility documentation, case report forms (CRFs), registration confirmations, and corresponding source documents across multiple centers, community physicians offices, and hospitals.

+ Assist, in collaboration with the RNC and physicians, 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 events in accordance with study sponsor requirements, federal regulations, and institutional guidelines.

+ Provide regular reports to tumor study group members and Principal Investigators on assigned studies using the clinical trials database and other reporting tools.

+ Serve as a liaison with study sponsors, anticipate sponsor needs, schedule monitoring visits and conference calls, and provide accurate, timely, and well-reasoned responses to sponsor queries.

+ Work closely with the RNC and other research personnel to ensure that investigators and staff conduct studies according to protocol treatment plans and Good Clinical Practice (GCP) guidelines.

+ Support recruitment, screening, enrolling, and consenting of patients for oncology clinical research studies, ensuring a positive and informative experience for participants.

+ Communicate effectively and comfortably with patients and multidisciplinary teams regarding informed consent, study procedures, and source documentation requirements.

+ Contribute to continuous improvement of clinical operations by maximizing available resources, maintaining high professional standards, and supporting large-scale enrollment goals across multiple active trials.

Essential Skills

+ Bachelors degree required.

+ 5 years of relevant clinical research experience, with additional consideration for candidates with up to five years of clinical research coordinator experience.

+ 5 years of experience in oncology research across disease-specific groups such as breast, lung, gastrointestinal (GI), and phase I trials.

Job Type & Location

This is a Contract position based out of New Brunswick, NJ.

Pay and Benefits

The pay range for this position is $38.00 - $45.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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…