Clinical Trial Specialist

Job Description

Job Description

Job Title: Clinical Trial Specialist Job Description

This role offers the opportunity to contribute to advanced, comprehensive cancer care for adults and children while supporting cutting-edge oncology clinical research. As a Clinical Trial Specialist, you help transform scientific discoveries into clinical practice by coordinating and managing cancer clinical trials, ensuring that studies are conducted in accordance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. You work closely with research nurses, physicians, sponsors, and patients to support the full lifecycle of oncology and hematology clinical trials, including pharmaceutical drug studies.

Responsibilities

• Coordinate the initiation and activation of new clinical trial protocols, ensuring all required approvals and plans are in place before study activation, including Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), data collection plans, and finance/contract approvals.
• Prepare and organize study tools and documentation, including study binders, medication diaries, eligibility checklists, calendars, and flow sheets, to support accurate and efficient study conduct.
• Use clinical trial databases and standard office software such as Excel and Word to develop and maintain study tools and trackers, ensuring information is current, accurate, and easily accessible.
• 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, documented in the medical record, and provided to patients in accordance with regulatory and institutional requirements.
• Register consented research participants with study sponsors, including industry sponsors and National Cancer Institute (NCI) cooperative groups, and accurately enter data into the clinical trials database.
• Maintain complete and organized research records for all patients enrolled in clinical trials, including patient consent, eligibility documentation, case report forms (CRFs), registration confirmations, and corresponding source documents, across multiple centers, community physician offices, and hospitals.
• Assist the RNC and physicians in grading adverse events using the most recent NCI common toxicity criteria or protocol-specific grading scales, ensuring consistency and accuracy in safety reporting.
• Complete Serious/Unexpected Adverse Event (SAE) forms for internal and multicenter studies in accordance with study sponsor requirements, federal regulations, and institutional guidelines.
• Provide regular, data-driven reports to tumor study group members and Principal Investigators on assigned studies using the clinical trials database, highlighting enrollment, status, and key metrics.
• Serve as a primary liaison with study sponsors by scheduling monitoring visits and conference calls, anticipating sponsor needs, and delivering accurate, timely, and thoughtful responses to sponsor queries.
• Work in collaboration with the RNC and investigators to ensure that all study personnel conduct the trial according to the approved treatment plan, protocol specifications, and GCP guidelines.
• Support recruitment, screening, enrolling, and consenting of patients for oncology clinical research studies, ensuring that eligibility criteria are met and that patients are fully informed.
• Contribute to high-volume enrollment efforts across multiple disease-specific groups and sites, helping to meet ambitious subject enrollment and active trial goals.

Essential Skills

• Bachelor’s degree required.
• One to four years of relevant clinical research experience, preferably as a Clinical Research Coordinator or in a similar role.
• Demonstrated experience in recruitment, screening, enrolling, and consenting of patients for clinical research studies.
• Experience with oncology clinical research studies, including familiarity with cancer protocols and patient populations.
• Experience with pharmaceutical drug trials and associated regulatory and sponsor requirements.
• Hematology clinical research experience or exposure to hematologic oncology studies.
• Solid knowledge and practical use of computer software programs such as Microsoft Excel, Word, and Access.
• Experience working with source documents and informed consent processes, including documentation and data integrity.
• Comfort and professionalism in communicating with patients, clinicians, and multidisciplinary research teams.
• Epic electronic health record experience and familiarity with clinical trial management systems.
• Strong attention to detail with the ability to maintain accurate and complete study records and documentation.
• Excellent organizational skills, including the ability to manage multiple studies, deadlines, and priorities.
• Effective verbal and written communication skills, enabling clear interaction with sponsors, investigators, and staff.
• Interpersonal skills that support collaboration across clinical operations, research administration, and support departments.
• Ability to hold oneself accountable to high standards of professional excellence and regulatory compliance.
• Resourcefulness in maximizing available resources and proactively resolving operational challenges.
• Commitment to ongoing personal and professional responsibility in a complex clinical research environment.

Additional Skills & Qualifications

• Experience as a Clinical Research Coordinator in oncology settings is highly beneficial.
• Familiarity with National Cancer Institute (NCI) common toxicity criteria and protocol-specific grading scales for adverse events.
• Understanding of Good Clinical Practice (GCP) guidelines and regulatory requirements governing clinical trials.
• Experience working within NCI-designated cancer centers or large academic research environments.
• Ability to produce regular reports and metrics from clinical trial databases for investigators and study teams.
• Demonstrated ability to anticipate sponsor and stakeholder needs and respond promptly and intelligently to queries.
• Track record of successfully supporting large volumes of subjects and multiple concurrent clinical trials.
• Ability to thrive in a fast-paced, high-enrollment environment with ambitious growth targets.
• Strong sense of ownership, initiative, and continuous improvement mindset in clinical operations.

Work Environment

The role sits within a robust clinical operations and research infrastructure that includes disease-specific groups such as breast, lung, phase I, and gastrointestinal oncology, as well as supporting functions in research administration, quality assurance, informatics, education, and finance. The organization maintains approximately 100 full-time research staff and enrolls around 5,000 subjects per year across Newark and multiple satellite sites throughout the state. You will contribute to a program with roughly 300 active trials and 1,000 active subjects, with a long-term goal of expanding to 2,500 active subjects, covering all phases of clinical trials for both adult and pediatric populations. The environment is professional, collaborative, and mission-driven, with significant enrollment needs and opportunities to impact patient care and research outcomes. Standard office technologies, electronic health records such as Epic, and dedicated clinical trial databases support daily work. The site is commutable via public transportation, and you will work alongside multidisciplinary teams committed to advancing cancer research and delivering high-quality care.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $32.00 - $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 fully onsite position in New Brunswick,NJ.

Application Deadline

This position is anticipated to close on Aug 25, 2026.

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.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on us.fitly.work for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.