Jersey City, New Jersey, USA
1 day ago
Clinical Trial Specialist
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, ensuring compliance with Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), and finance/contract approvals prior to study activation. You will develop and prepare study tools, collaborate with Research Nurse Clinicians and physicians to confirm protocol eligibility, and ensure informed consent is properly obtained and documented. Additionally, you will register consented research patients with study sponsors and maintain comprehensive research records for all enrolled patients.

ResponsibilitiesCoordinate the initiation and activation of new clinical trial protocols, ensuring compliance with SRB, IRB, and HROC approvals.Develop and prepare study tools such as study binders, medication diaries, eligibility checklists, and flow sheets using Oncore®, Excel®, and Word®.Review patients' charts and medical history to confirm protocol eligibility and obtain necessary source documents.Ensure informed consent forms are obtained, signed, documented, and provided to patients.Register consented research patients with study sponsors and input data into the Oncore® clinical trials database.Maintain comprehensive research records for all patients enrolled in clinical trials across various centers and locations.Assist with grading adverse events using NCI common toxicity criteria or protocol-specific grading scales.Complete Serious/Unexpected Adverse Event (SAE) forms for all required events.Provide regular reports to tumor study group members and Principal Investigators on assigned studies.Serve as a liaison with study sponsors, schedule monitoring visits, and respond to sponsors' queries.Ensure personnel, including investigators, conduct studies according to treatment plans and GCP guidelines.Essential SkillsClinical Research Coordinator experience in Oncology for 2-3 years.Proficiency in screening patients and coordinating studies.Effective communication skills with patients and team members.Experience with pre-screening patients and handling source documents.Additional Skills & QualificationsBachelor's Degree required.Solid knowledge of computer software programs including Excel®, Word®, and/or Access®.Detail-oriented with excellent organizational and interpersonal skills.Ability to hold oneself accountable to high standards of professional excellence.Work Environment

You will be working in various locations including Long Branch, Toms River, Newark, and seven other sites around the state. The role is part of a diverse team including Clinical Operations, Research Assistants, Quality Assurance, Informatics, Education, and Finance. With 100 full-time employees and 5,000 subjects enrolled annually, there is a huge enrollment need for 300 active trials involving both adult and pediatric phases. The work environment is collaborative, dynamic, and focused on achieving long-term goals.

Pay and Benefits

The pay range for this position is $33.00 - $37.00/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 Jersey City,NJ.

Application Deadline

This position is anticipated to close on Jul 28, 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.

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