Clinical Trial Specialist

Job Description

Job Description

Job Title : Clinical Trial Specialist

Job Description

As a Clinical Trial Specialist, you will coordinate the initiation and activation of all new clinical trial protocols. This involves verifying approvals from various boards and committees, preparing study tools, and ensuring compliance with regulatory requirements. You will collaborate with Research Nurse Clinicians and physicians to review patients’ charts and confirm protocol eligibility.

Responsibilities

• Coordinate the initiation and activation of clinical trial protocols, ensuring all necessary approvals and plans are in place before study activation.
• Prepare study tools, including study binders, medication diaries, eligibility checklists, and flow sheets as required.
• Develop study tools using software such as Excel, Word, and others.
• Review patients’ charts and medical history in collaboration with the Research Nurse Clinician and / or physician to confirm protocol eligibility and obtain necessary source documents.
• Ensure IRB-approved informed consent forms are obtained, signed, and placed in medical records.
• Register consented research patients with study sponsors and input data into the clinical trials database.
• Maintain research records for all patients enrolled in clinical trials, including patient consent, eligibility, and case report forms.
• Assist with grading adverse events using the latest NCI common toxicity criteria and complete necessary forms for serious / unexpected adverse events.
• Provide regular reports to tumor study group members and Principal Investigators on assigned studies.
• Serve as a liaison with study sponsors, scheduling monitoring visits and conference calls, and responding to sponsor queries.
• Ensure that personnel, including investigators, conduct the study according to the treatment plan and GCP guidelines.

Essential Skills

Additional Skills & Qualifications

Work Environment

The position is part of a clinical operations team with 40 full-time employees, focusing on various disease-specific groups such as breast, lung, phase 1, and GI. The environment includes departments such as Research Administration, Quality Assurance, Informatics, Education, and Finance. With 100 full-time employees, the team manages 300 active trials and 1,000 active subjects with a long-term goal of 2,500 subjects. The trials cover all phases for both adult and pediatric subjects across multiple sites, including Newark and seven other locations in the state.

Job Type & Location

This is a Contract position based out of Somerville, New Jersey.

Pay and Benefits

The pay range for this position is $30.00 - $36.00 / 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 :

Workplace Type

This is a fully onsite position in Somerville,NJ.

Application Deadline

This position is anticipated to close on Oct 29, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.