Job Title: Clinical Trial SpecialistJob DescriptionThe Clinical Trial Specialist coordinates and supports the full lifecycle of oncology clinical trials, from protocol initiation and activation through patient enrollment, data collection, safety reporting, and ongoing sponsor communication. This role ensures that all studies adhere to regulatory requirements, institutional policies, and Good Clinical Practice (GCP) guidelines while providing high-quality support to research nurses, physicians, and patients.
Responsibilities
- Coordinate the initiation and activation of new clinical trial protocols, ensuring completion and verification of Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), data collection plans, and finance/contract approvals prior to study activation.
- Prepare and organize study tools, including study binders, medication diaries, eligibility checklists, calendars, and flow sheets, to support accurate and efficient trial conduct.
- Use clinical trials management systems and software such as Excel and Word to develop and maintain study tools, tracking documents, and patient-related materials.
- Collaborate with Research Nurse Clinicians and physicians to review patients charts and medical histories, confirm protocol eligibility, and obtain necessary source documents and medical record documentation.
- Ensure that IRB-approved informed consent forms are properly obtained, signed, documented in the medical record, and that copies are provided to patients in accordance with regulatory and institutional requirements.
- Register consented research patients with study sponsors, including industry partners and National Cancer Institute (NCI) 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 patient consent forms, eligibility documentation, case report forms (CRFs), registration confirmations, and corresponding source documents, across centers, community physicians offices, and hospitals.
- Assist, in collaboration with the Research Nurse Clinician and physician, in grading adverse events using the most recent 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 as required by study sponsors, 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, understanding and anticipating sponsor needs, scheduling monitoring visits and conference calls, and providing accurate, timely, and well-supported responses to sponsor queries.
- Work with Research Nurse Clinicians to ensure that investigators and other personnel conduct studies according to the treatment plan, protocol requirements, and GCP guidelines.
- Support screening and recruitment of patients for clinical trials, helping to coordinate study visits and ensure smooth patient flow through the research process.
- Communicate comfortably and professionally with patients, answering questions related to study procedures and coordinating their participation in clinical trials.
Essential Skills
- Bachelors degree required.
- One to three years of relevant clinical research experience, preferably as a Clinical Research Coordinator or in a similar role.
- Experience in oncology clinical research, including familiarity with tumor study groups and oncology-specific protocols.
- Demonstrated experience with informed consent processes, including obtaining, documenting, and maintaining consent forms in accordance with IRB requirements.
- Ability to recruit, screen, and enroll patients into clinical trials while maintaining protocol eligibility standards and accurate source documentation.
- Solid knowledge of computer software programs such as Excel, Word, and Access for data tracking, reporting, and development of study tools.
- Comfort and experience communicating directly with patients in a clinical research or healthcare setting.
- Strong attention to detail and ability to maintain accurate, complete research records and case report forms.
- Excellent organizational skills with the ability to manage multiple studies, deadlines, and competing priorities.
- Strong written and verbal communication skills and the ability to interact effectively with physicians, nurses, sponsors, and other research staff.
- Ability to follow GCP guidelines and institutional policies in the conduct of clinical trials.
Additional Skills & Qualifications
- Experience working with oncology disease-specific groups such as breast, lung, gastrointestinal, phase I, or other tumor-focused teams.
- Familiarity with NCI common toxicity criteria and protocol-specific grading scales for adverse event assessment.
- Experience completing Serious/Unexpected Adverse Event (SAE) documentation for industry-sponsored and cooperative group trials.
- Ability to provide clear, timely, and well-organized responses to study sponsors and regulatory monitors.
- Demonstrated ability to be detail-oriented, self-accountable, and committed to high standards of professional excellence.
- Resourceful mindset with the ability to maximize available resources and proactively solve problems.
- Strong interpersonal skills and the ability to build collaborative relationships with multidisciplinary teams, including clinical operations, regulatory affairs, quality assurance, informatics, education, and finance.
- Commitment to ongoing personal and professional responsibility and continuous improvement in clinical research practices.
Work EnvironmentThe role operates within a large, dynamic clinical operations structure that includes disease-specific groups such as breast, lung, phase I, and gastrointestinal, as well as dedicated teams in regulatory affairs, quality assurance, informatics, education, and finance. The organization supports approximately 100 full-time research staff and manages around 300 active trials across all phases for both adult and pediatric populations, with roughly 5,000 subjects enrolled per year and a long-term goal of significantly expanding active subject enrollment. Work spans a main site in Newark and multiple affiliated locations across the state, supporting community physicians offices and hospitals. The environment is fast-paced and highly collaborative, with substantial enrollment needs and exposure to a wide range of oncology studies, offering opportunities to work with complex protocols, sophisticated clinical trial management systems, and multidisciplinary teams dedicated to advancing cancer research. Job Type & LocationThis is a Contract to Hire position based out of New Brunswick, NJ. Pay and BenefitsThe pay range for this position is $35.00 - $38.00/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 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) Job Type & LocationThis is a Contract to Hire position based out of New Brunswick, NJ. Application DeadlineThis position is anticipated to close on Nov 16, 2026. Workplace TypeThis is a fully onsite position in New Brunswick,NJ.About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
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