Clinical Trial Specialist

Clinical Trial Specialist

The Clinical Trial Specialist coordinates and supports all aspects of clinical research studies, with a strong focus on oncology trials. This role oversees the initiation and activation of new clinical trial protocols, ensures regulatory and ethical compliance, and maintains accurate research documentation throughout the life of each study. The position involves close collaboration with research nurses, physicians, sponsors, and patients, and requires frequent patient-facing interaction to support recruitment, screening, enrollment, and informed consent processes.

Responsibilities include:

• Coordinate the initiation and activation of new clinical trial protocols, ensuring all required approvals are in place before study activation, including Scientific Review Board, Institutional Review Board, Human Research Oversight Committee, data collection plans, and finance or contract approvals.
• Prepare and organize study tools such as study binders, medication diaries, eligibility checklists, calendars, and flow sheets to support accurate and efficient trial conduct.
• Use clinical trial management systems and software such as Excel and Word to develop and maintain study tools, documentation templates, and tracking systems.
• Collaborate with the Research Nurse Clinician 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 Research Nurse Clinician and physicians, ensure that IRB-approved informed consent forms are properly obtained, signed, documented in the medical record, and that copies are provided to patients.
• Register consented research patients with study sponsors, including industry partners and cooperative groups, and enter required data into the clinical trials database.
• Maintain complete and accurate research records for all patients enrolled in clinical trials, including consent forms, eligibility documentation, case report forms, registration confirmations, and corresponding source documents across all participating centers and sites.
• Assist, in collaboration with the Research Nurse Clinician and physicians, in grading adverse events using the most recent National Cancer Institute common toxicity criteria or protocol-specific grading scales.
• Complete Serious and Unexpected Adverse Event forms for internal and multicenter events in accordance with sponsor requirements, federal regulations, and institutional guidelines.
• Ensure that research records remain current and compliant for all enrolled patients, including those treated at main centers, community physicians' offices, and affiliated hospitals.
• Generate and provide regular reports from the clinical trials database to tumor study group members and Principal Investigators for all assigned studies.
• Serve as a primary liaison with study sponsors, anticipate sponsor needs, schedule monitoring visits and conference calls, and provide accurate and timely responses to sponsor queries.
• Work closely with the Research Nurse Clinician to ensure that all personnel, including investigators, conduct studies according to the approved treatment plans and Good Clinical Practice guidelines.
• Support patient recruitment, screening, enrollment, and consenting activities, ensuring a positive and professional patient experience throughout their participation in clinical trials.
• Assist with coordination of study-related procedures, including lab processing and handling, in alignment with protocol requirements and institutional standards.

Essential skills include:

• Two to four years of experience as a Clinical Research Coordinator or in a closely related clinical research role.
• Two to three years of relevant clinical research experience, with a strong emphasis on oncology clinical trials.
• Demonstrated experience in patient recruitment, screening, enrollment, and obtaining informed consent for clinical trials.
• Clinical and patient-facing experience in a recent role, with comfort and competence in communicating directly with patients.
• Oncology clinical research experience, including familiarity with oncology-specific protocols and patient populations.
• Experience with lab processing and handling in a clinical research setting.
• Proficiency with computer software such as Excel, Word, and database or clinical trial management systems.
• Ability to work with source documents, medical records, and case report forms with high attention to detail and accuracy.
• Strong organizational skills with the ability to manage multiple active studies and competing priorities.
• Excellent written and verbal communication skills for effective interaction with patients, investigators, and study sponsors.
• Solid understanding of Good Clinical Practice guidelines and regulatory requirements related to clinical trials.

Additional skills and qualifications include:

• Bachelor's degree required.
• Experience specifically as a Clinical Research Coordinator is highly valued.
• Experience working on oncology clinical trials across different phases is beneficial.
• Familiarity with adverse event grading using National Cancer Institute common toxicity criteria or protocol-specific scales.
• Experience completing Serious and Unexpected Adverse Event documentation according to sponsor and regulatory requirements.
• Ability to anticipate the needs of study sponsors and respond intelligently and promptly to queries.
• Detail-oriented approach with a commitment to maintaining complete, accurate, and compliant research records.
• Strong interpersonal skills, with the ability to collaborate effectively with research nurses, physicians, and cross-functional teams.
• Demonstrated accountability to high standards of professional excellence and a willingness to take personal and professional responsibility on an ongoing basis.

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 Aug 17, 2026.