Job Description
Job DescriptionJob Title: Clinical Trial Specialist
Job Description
The Clinical Trial Specialist is responsible for coordinating the initiation and activation of all new clinical trial protocols. This includes verifying approvals from the Scientific Review Board, Institutional Review Board, Human Research Oversight Committee, and ensuring data collection plans and finance/contract approvals are in place prior to study activation. The role involves preparing study tools such as study binders, medication diaries, eligibility checklists, and flow sheets, as well as developing these tools using software like Excel and Word. The specialist will work closely with the Research Nurse Clinician and/or physician to confirm protocol eligibility by reviewing patients’ charts and medical history, obtaining necessary source documents, and ensuring informed consent forms are properly managed.
Responsibilities
- Coordinate the initiation and activation of new clinical trial protocols.
- Verify approvals from relevant boards and committees prior to study activation.
- Prepare and develop study tools such as study binders, medication diaries, and eligibility checklists.
- Review patients' charts and medical history to confirm protocol eligibility.
- Ensure informed consent forms are obtained, signed, and properly filed.
- 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.
- Assist with grading adverse events and complete necessary forms for serious/unexpected adverse events.
- Provide regular reports to tumor study group members and Principal Investigator on assigned studies.
- Serve as a liaison with study sponsors, schedule monitoring visits, and respond to sponsors’ queries.
- Ensure studies are conducted according to the treatment plan and Good Clinical Practice guidelines.
Essential Skills
- Experience as a Clinical Research Coordinator or in clinical research, specifically in Oncology.
- 1-2 years of clinical research coordinator experience with oncology OR 3-4 years of complex therapeutic area experience.
- Experience and comfort communicating with patients.
- Solid knowledge of software programs such as Excel, Word, and Access.
Additional Skills & Qualifications
- Bachelor’s Degree required.
- 1-3 years of relevant clinical research experience.
- Detail-oriented with excellent organizational, communication, and interpersonal skills.
- Accountable to high standards of professional excellence.
- Resourceful and able to maximize resources efficiently.
Work Environment
The work environment includes a clinical operations team of 40 full-time employees (FTEs) covering disease-specific groups such as breast, lung, phase 1, and gastrointestinal, as well as roles in regulatory affairs, quality assurance, informatics, education, and finance. The organization currently has 100 FTEs, with 5,000 subjects enrolled per year across Newark and seven other sites around the state. With 300 active trials and 1,000 active subjects, the long-term goal is to reach 2,500 active subjects, covering all phases for both adult and pediatric trials.
Pay and Benefits
The pay range for this position is $30.00 - $34.00/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 Somerville,NJ.
Application Deadline
This position is anticipated to close on Jul 16, 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.