Clinical Research Coordinator(LT)

Job Description

Job Description

Job Title: Clinical Research Coordinator (LT) Job Description

The Clinical Research Coordinator (LT) supports the successful initiation, activation, and ongoing management of oncology clinical trials across multiple disease-specific groups and phases. This role ensures that studies comply with regulatory requirements, Good Clinical Practice (GCP) guidelines, and protocol-specific procedures while providing high-quality support to investigators, research nurses, and patients throughout the clinical research process.

• Coordinate the initiation and activation of new clinical trial protocols by verifying 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 such as study binders, medication diaries, eligibility checklists, calendars, and flow sheets, ensuring they are complete, accurate, and aligned with protocol requirements.
• Use clinical trial management systems and Microsoft Excel and Word to develop and maintain study tools, tracking documents, and study-related templates.
• Collaborate with the Research Nurse Clinician (RNC) and/or physician to review patients’ charts and medical history, confirm protocol eligibility, and obtain necessary source documents from the medical record.
• Ensure that IRB-approved informed consent forms are properly obtained, signed, documented 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 partners and cooperative groups, and enter relevant data into the clinical trials database.
• Maintain complete and organized research records for all patients enrolled on clinical trials, including patient consent, eligibility documentation, Case Report Forms (CRFs), registration confirmations, and corresponding source documents across all participating centers, community physician offices, and hospitals.
• Assist the RNC and physicians in 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 compliance with study sponsor requirements, federal regulations, and institutional guidelines.
• Provide regular reports to tumor study group members and Principal Investigators using the clinical trials database, summarizing enrollment, subject status, and key study metrics for assigned trials.
• Serve as a primary liaison with study sponsors by understanding and anticipating sponsor needs, scheduling monitoring visits and conference calls, and providing accurate, timely, and well-documented responses to sponsor queries.
• Work in collaboration with the RNC to ensure that all personnel, including investigators, conduct studies according to the treatment plan, protocol requirements, and GCP guidelines.
• Screen potential patients for clinical trial eligibility, coordinate patient scheduling and study visits, and support recruitment and enrollment efforts across assigned trials.
• Communicate clearly and compassionately with patients to explain study procedures, answer questions, and support their participation throughout the trial.
• Contribute to continuous process improvement by maintaining high standards of documentation, organization, and compliance in all aspects of clinical trial coordination.

• Bachelor’s degree required.
• One to three years of relevant clinical research experience, preferably in a Clinical Research Coordinator role.
• Demonstrated experience in clinical research with exposure to oncology trials, including patient screening, coordination of study activities, and handling of source documents.
• Solid knowledge of computer software programs such as Microsoft Excel, Word, and/or Access.
• Experience obtaining, documenting, or supporting informed consent processes for clinical research participants.
• Experience and comfort communicating directly with patients in a clinical or research setting.
• Ability to interpret and apply protocol requirements, eligibility criteria, and regulatory guidelines in daily work.
• Strong attention to detail and accuracy in documentation, data entry, and record maintenance.
• Excellent organizational skills with the ability to manage multiple studies, tasks, and timelines simultaneously.
• Effective written and verbal communication skills to interact with patients, investigators, research nurses, and sponsors.
• Ability to work collaboratively within a multidisciplinary research team and follow GCP and institutional policies.

• Detail-oriented approach with a strong commitment to maintaining high standards of professional excellence.
• Strong interpersonal skills with the ability to build effective working relationships with physicians, research nurses, sponsors, and other stakeholders.
• Proactive and resourceful mindset with the ability to maximize available resources and solve problems independently.
• Willingness to seek and accept personal and professional responsibility on an ongoing basis, including continuous learning and development.
• Familiarity with oncology clinical research operations, including recruitment, enrollment, and long-term follow-up of subjects, is highly beneficial.
• Experience working within large or complex clinical research programs with multiple active trials and high enrollment volumes is a plus.

This position is based in a large, dynamic clinical research environment in Livingston, with additional activity across Newark and multiple satellite sites throughout the state. The clinical operations group includes approximately 40 full-time employees organized into disease-specific teams such as breast, lung, phase I, and gastrointestinal oncology, and is supported by specialized functions in Regulatory Affairs, Quality Assurance, Informatics, Education, and Finance. The broader program includes around 100 full-time employees and manages approximately 300 active trials with about 1,000 active subjects, with a long-term goal of enrolling and following up to 2,500 subjects. The site enrolls roughly 5,000 subjects per year across all phases of clinical research, including adult and pediatric trials, providing exposure to a wide range of study designs and therapeutic areas. The work environment is fast-paced and highly collaborative, with significant enrollment needs and opportunities to support newly hired principal investigators who are eager to learn and conduct research. Staff routinely use clinical trial management systems and standard office software such as Excel, Word, and Access, and work closely with multidisciplinary teams in a professional clinical and office setting.

This is a Contract position based out of Livingston, NJ.

The pay range for this position is $25.00 - $25.00/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)

This is a fully onsite position in Livingston,NJ.

This position is anticipated to close on Sep 1, 2026.

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