Clinical Trial Specialist

Clinical Trial Specialist

The Clinical Trial Specialist is responsible for coordinating the initiation and activation of new clinical trial protocols. This role involves verifying approvals from various boards, preparing study tools, and ensuring informed consent forms are properly managed. The specialist will collaborate with research nurses and physicians to confirm protocol eligibility and manage patient records.

Responsibilities:

• Coordinate the initiation and activation of all new clinical trial protocols, ensuring necessary approvals and data collection plans are in place.
• Prepare study tools such as study binders, medication diaries, eligibility checklists, and flow sheets.
• Develop study tools using computer software such as Excel and Word.
• Collaborate with Research Nurse Clinicians and physicians to review patient charts and medical history for protocol eligibility.
• Ensure that informed consent forms are obtained, signed, and properly documented in medical records.
• Register consented research patients with study sponsors and maintain records in the clinical trials database.
• Maintain comprehensive 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 groups and Principal Investigators on assigned studies.
• Serve as a liaison with study sponsors, schedule monitoring visits, and respond to sponsors' queries.
• Ensure that personnel, including investigators, conduct studies according to treatment plans and Good Clinical Practice (GCP) guidelines.

Essential Skills:

• 2-3 years of experience as a Clinical Research Coordinator.
• Experience in clinical research, particularly in oncology.
• Proficiency in managing informed consent and source documents.
• Ability to recruit and enroll patients.
• Comfortable communicating with patients.

Additional Skills & Qualifications:

• Bachelor's Degree required.
• Solid knowledge of computer software programs such as Excel, Word, and Access.
• Detail-oriented with excellent organizational, communication, and interpersonal skills.
• Ability to hold oneself accountable to high standards of professional excellence.
• Resourceful and able to maximize resources effectively.

Work Environment:

The role is based at an NCI Designated Cancer Center with a diverse and dynamic team of 100 full-time employees. The team operates across various disease-specific groups including breast, lung, GI, and more. The center enrolls approximately 5,000 subjects annually across Newark and seven other sites. With over 300 active trials, the environment is fast-paced and focused on both adult and pediatric phases.

Job Type & Location:

This is a Contract to Hire position based out of Newark, NJ.

Pay and Benefits:

The pay range for this position is $35.00 - $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 hybrid position in Newark, NJ.

Application Deadline:

This position is anticipated to close on Jul 15, 2026.