Buscar empleo: 147 ofertas de trabajo de federal contract en Orange, New Jersey (mayo 2026)

Clinical Trial Specialist

hace 13 días

Livingston

Job Description Job Title: Clinical Trial Specialist Job Description The Clinical Trial Specialist coordinates and supports all aspects of clinical research studies from initiation through activation and ongoing conduct. This role ensures that protocols meet regulatory, ethical, and institutional requirements, that patient eligibility and consent are properly documented, and that study data and records are accurate, complete, and audit-ready. The Clinical Trial Specialist works closely with research nurses, physicians, and study sponsors to maintain high standards of Good Clinical Practice (GCP) and to help advance a large, diverse portfolio of oncology clinical trials. Responsibilities • Coordinate the initiation and activation of new clinical trial protocols, ensuring all required approvals and documentation are in place prior to study activation., • Verify Scientific Review Board, Institutional Review Board, Human Research Oversight Committee, data collection plans, and finance/contract approvals before activating studies., • Prepare and organize study tools such as study binders, medication diaries, eligibility checklists, calendars, and flow sheets as required., • Use clinical trial management systems and Microsoft Excel and Word to develop and maintain study tools and documentation., • Collaborate with Research Nurse Clinicians and physicians to review patient charts and medical histories, confirm protocol eligibility, and obtain necessary source documents., • Ensure IRB-approved informed consent forms are properly obtained, signed, filed in the medical record, and that copies are provided to patients under the direction of the Research Nurse Clinician and/or physician., • Register consented research participants with study sponsors, including industry sponsors and cooperative groups, and enter relevant data into the clinical trials database., • Maintain complete and accurate research records for all patients enrolled on clinical trials, including consents, eligibility documentation, case report forms, registration confirmations, and corresponding source documents across centers, community practices, and hospitals., • Assist in grading adverse events using the most recent National Cancer Institute common toxicity criteria or protocol-specific grading scales in collaboration with the Research Nurse Clinician and physician., • Complete Serious/Unexpected Adverse Event forms for internal and multicenter serious or unexpected adverse events in accordance with sponsor requirements, federal regulations, and institutional guidelines., • Provide regular status reports to tumor study group members and Principal Investigators on assigned studies using the clinical trials database and other reporting tools., • Serve as a primary liaison with study sponsors, schedule monitoring visits and conference calls, and provide timely, accurate, and well-supported responses to sponsor queries., • Support and monitor adherence to protocol treatment plans and Good Clinical Practice guidelines by all involved personnel, in collaboration with the Research Nurse Clinician., • Screen potential participants, coordinate study-related activities, and support recruitment and enrollment efforts., • Communicate effectively and professionally with patients to explain study procedures, address questions, and support a positive research experience., • Anticipate sponsor and study team needs, proactively address issues, and contribute to continuous improvement of clinical research operations. Essential Skills • Bachelor’s degree required., • One to three years of relevant clinical research experience, preferably as a Clinical Research Coordinator or in a similar role., • Experience in clinical research within oncology, including exposure to adult and/or pediatric trials., • Demonstrated experience with patient screening, recruitment, and enrollment into clinical studies., • Proficiency using computer software such as Microsoft Excel, Word, and, where applicable, database tools like Access., • Experience working with clinical trial management systems and maintaining electronic or paper research records., • Working knowledge of informed consent processes and regulatory requirements for clinical research., • Ability to review medical records and source documents to confirm protocol eligibility and support data collection., • Strong attention to detail and ability to maintain accurate, complete, and compliant documentation., • Excellent organizational skills with the ability to manage multiple studies and tasks simultaneously., • Strong verbal and written communication skills, including comfort and professionalism when communicating with patients., • Ability to collaborate effectively with research nurses, physicians, and multidisciplinary research teams., • Commitment to Good Clinical Practice and adherence to institutional and regulatory guidelines. Additional Skills & Qualifications • Solid knowledge of additional computer software and databases, including clinical trial management platforms., • Experience supporting oncology disease-specific groups such as breast, lung, gastrointestinal, or early-phase (Phase I) trials., • Familiarity with National Cancer Institute common toxicity criteria and protocol-specific adverse event grading scales., • Experience completing Serious/Unexpected Adverse Event documentation for internal and multicenter trials., • Ability to anticipate study sponsor needs and provide proactive, well-reasoned responses to queries., • Demonstrated ability to hold oneself accountable to high standards of professional excellence., • Proven resourcefulness in maximizing available resources and solving operational challenges., • Strong interpersonal skills with the ability to build positive relationships with investigators, newly hired principal investigators, and broader research teams., • Commitment to ongoing personal and professional development and willingness to assume responsibility for continuous learning. Work Environment The role is based within a large, dynamic clinical operations and research environment with multiple disease-specific groups, including breast, lung, gastrointestinal, and Phase I programs. The organization supports approximately 40 clinical operations professionals and around 100 full-time employees overall, including teams in Regulatory Affairs, Quality Assurance, Informatics, Education, and Finance. The research program manages a high volume of clinical activity, with approximately 5,000 subjects enrolled per year, around 300 active trials, and about 1,000 active subjects, with a long-term goal of 2,500 active subjects. Studies span all phases of clinical research and include both adult and pediatric populations. The role supports a network of sites, including locations in Newark and multiple additional sites across the state, with significant enrollment needs and opportunities to contribute to the growth of the research portfolio. The environment emphasizes collaboration with newly hired principal investigators who are eager to conduct research, and it relies heavily on clinical trial management systems, electronic databases, and standard office software. Work is typically performed in clinical and office settings, with standard business hours aligned to research and clinic operations. Job Type & Location This is a Contract position based out of Livingston, 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 fully onsite position in Livingston,NJ. Application Deadline This position is anticipated to close on May 27, 2026. 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

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