Clinical Trial Specialist

Job Description

Job Description

Job Title: Clinical Trial Specialist Job Description

The Clinical Trial Specialist coordinates and supports the initiation, activation, and ongoing conduct of oncology clinical trials across multiple sites. This role ensures that all regulatory, ethical, and operational requirements are met prior to and throughout study activation, maintains complete and accurate research records, and collaborates closely with research nurses and physicians to safeguard patient safety and data integrity. The position involves preparing study tools, managing patient registration and documentation, supporting adverse event reporting, and serving as a key liaison between internal study teams and external sponsors.

Responsibilities

• Coordinate the initiation and activation of new clinical trial protocols, ensuring completion and verification of Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), data collection plans, and finance/contract approvals prior to study activation.
• Prepare and organize study tools, including study binders, medication diaries, eligibility checklists, calendars, and flow sheets, to support protocol compliance and efficient study conduct.
• Use Oncore®, Excel®, and Word® to develop and maintain study tools and documentation such as eligibility checklists, medication diaries, calendars, and flow sheets as required by each protocol.
• Review patients charts and medical histories in collaboration with the Research Nurse Clinician and/or physician to confirm protocol eligibility and obtain necessary source documents and medical record documentation.
• Ensure that IRB-approved informed consent forms are correctly obtained, signed, filed in the medical record, and that copies are provided to patients in accordance with regulatory and institutional requirements.
• Register consented research patients with study sponsors, including industry sponsors and NCI cooperative groups, and accurately input patient and study information into the Oncore® clinical trials database.
• Maintain complete and organized research records for all patients enrolled in clinical trials, including consent forms, eligibility documentation, case report forms (CRFs), registration confirmations, and corresponding source documents, across centers, community physicians offices, and hospitals.
• Assist the Research Nurse Clinician and physicians with grading adverse events using the most recent National Cancer Institute (NCI) common toxicity criteria or protocol-specific grading scales.
• Complete Serious/Unexpected Adverse Event (SAE) forms for internal and multicenter serious or unexpected adverse events, in accordance with study sponsor requirements, federal regulations, and institutional guidelines.
• Provide regular reports using Oncore® to tumor study group members and Principal Investigators on all assigned studies, summarizing enrollment, status, and key metrics.
• Serve as a liaison with study sponsors, understanding and anticipating sponsor needs, scheduling monitoring visits and conference calls, and providing accurate, timely, and well-reasoned responses to sponsor queries.
• Collaborate with the Research Nurse Clinician to ensure that all personnel, including investigators, conduct studies according to the treatment plan, protocol requirements, and Good Clinical Practice (GCP) guidelines.
• Support the screening and pre-screening of patients for trial eligibility, coordinating study visits and logistics, and assisting with patient recruitment and enrollment processes.
• Communicate effectively and professionally with patients, clinical staff, and study team members to facilitate smooth study operations and address questions related to trial participation.
• Maintain a high level of attention to detail and organization in managing multiple trials, subjects, and documentation requirements in a fast-paced, high-volume clinical research environment.

Essential Skills

• Two to three years of relevant clinical research experience, specifically as a Clinical Research Coordinator in oncology.
• Demonstrated experience in clinical research, including patient screening, recruitment, enrollment, and coordination of study activities.
• Experience and comfort communicating directly with patients in a clinical research setting, including discussing study procedures and requirements.
• Proficiency in managing and maintaining source documents and research records for clinical trials.
• Solid knowledge of computer software programs such as Excel®, Word®, and/or Access® for data management and documentation.
• Ability to use Oncore® or similar clinical trials management systems to develop study tools, manage patient data, and generate reports.
• Strong attention to detail with the ability to maintain accurate and complete documentation for multiple concurrent studies.
• Excellent organizational skills with the ability to prioritize tasks and manage time effectively in a complex research environment.
• Strong communication and interpersonal skills to work collaboratively with research nurses, physicians, sponsors, and other team members.
• Ability to understand and apply Good Clinical Practice (GCP) guidelines and protocol requirements in daily work.
• Comfort with grading adverse events using NCI common toxicity criteria or protocol-specific scales and supporting SAE documentation.

Additional Skills & Qualifications

• Bachelors degree required.
• Clinical research experience in oncology across various disease-specific groups such as breast, lung, gastrointestinal, and phase I studies is highly beneficial.
• Experience working with adult and pediatric patients in clinical trial settings is an advantage.
• Demonstrated ability to be detail-oriented and to maintain high standards of professional excellence.
• Ability to hold oneself accountable, take ownership of responsibilities, and seek continuous personal and professional development.
• Resourcefulness in maximizing available resources and resolving operational challenges in study coordination.
• Strong interpersonal skills with the ability to build effective working relationships across multidisciplinary teams, including clinical operations, regulatory affairs, quality assurance, informatics, education, and finance.
• Comfort working within large, complex research programs with high enrollment volumes and multiple active trials.

Work Environment

This role operates within a large, multi-site clinical research program with locations including Long Branch, Toms River, Newark, and several additional sites across the state. The environment includes approximately 100 full-time research staff, with around 40 in clinical operations and dedicated disease-specific groups such as breast, lung, phase I, and gastrointestinal oncology, as well as teams in regulatory affairs, quality assurance, informatics, education, and finance. The program manages roughly 300 active trials and about 1,000 active subjects, with an annual enrollment of approximately 5,000 subjects and a long-term goal of 2,500 active subjects. Clinical trials span all phases and include both adult and pediatric populations. The work setting is fast-paced and highly collaborative, requiring strong coordination and communication across disciplines and sites. Standard professional clinical attire is expected, and daily work involves extensive use of electronic systems such as Oncore®, Excel®, Word®, and other tools to support study management and documentation.

Job Type & Location

This is a Contract position based out of Jersey City, NJ.

Pay and Benefits

The pay range for this position is $33.00 - $37.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 Oct 15, 2026.

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