Clinical Research Coordinator
hace 5 días
Livingston
Job Description Job Title: Clinical Research Coordinator – Oncology Job Description This role leads the initiation and activation of new oncology clinical trial protocols and coordinates day-to-day study operations across multiple sites. The Clinical Research Coordinator ensures all regulatory, ethical, and contractual requirements are met prior to study activation, supports investigators and research nurses in delivering high-quality, compliant research, and serves as a key liaison between patients, study sponsors, and internal research teams. Responsibilities • Lead and coordinate the initiation and activation of new clinical trial protocols, ensuring all pre-activation requirements are complete., • Verify approvals from Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), data collection plans, and finance/contract approvals prior to study activation., • Coordinate the preparation of study tools, including 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 the Research Nurse Clinician (RNC) and/or physician to review patients’ charts and medical histories to confirm protocol eligibility., • Obtain and organize source documents, such as medical record documentation, to support eligibility and study data., • Under the direction of the RNC and/or physician, ensure that IRB-approved informed consent is obtained, properly signed, filed in the medical record, and that a copy is provided to the patient., • Register consented research patients with study sponsors, including industry partners and cooperative groups, and enter data into the clinical trials database., • Maintain complete and accurate research records for all patients enrolled on clinical trials, including consent forms, eligibility documentation, case report forms (CRFs), registration confirmations, and corresponding source documents., • Support and track clinical trials conducted at centers, community physicians’ offices, and hospitals, ensuring consistency and compliance across locations., • Collaborate with the RNC and physician to assist 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 sponsor, federal, and institutional requirements., • Ensure ongoing maintenance and organization of research records for all assigned trials and subjects, including updates to consents, eligibility, CRFs, and source documents., • Generate and provide regular reports from the clinical trials database to tumor study group members and Principal Investigators on all assigned studies., • Understand and anticipate the needs of study sponsors, acting as a primary study liaison and maintaining professional, responsive communication., • Schedule and coordinate sponsor monitoring visits and conference calls, ensuring all required documentation and data are available and accurate., • Provide accurate, timely, and well-supported responses to sponsor queries and data requests., • In collaboration with the RNC, ensure that all personnel, including investigators, conduct studies according to the treatment plan, protocol requirements, and Good Clinical Practice (GCP) guidelines., • Recruit and screen patients for clinical trials, coordinating study visits and procedures in alignment with protocol timelines., • Communicate clearly and compassionately with patients to explain study procedures, address questions, and support their participation throughout the trial. Essential Skills • Bachelor’s degree required., • One to three years of relevant clinical research experience, preferably as a Clinical Research Coordinator., • Experience in oncology clinical research, including screening and coordination of study participants., • Demonstrated experience obtaining or coordinating informed consent in a clinical research setting., • Experience recruiting, enrolling, and following patients on clinical trials., • Proficiency with computer software programs such as Microsoft Excel, Word, and Access, or similar applications., • Ability to manage and maintain accurate source documents and research records., • Strong communication skills and comfort communicating directly with patients., • Excellent organizational skills with the ability to manage multiple studies and tasks simultaneously., • High attention to detail and accuracy in documentation and data entry., • Ability to work collaboratively with physicians, research nurses, and cross-functional research teams., • Commitment to Good Clinical Practice (GCP) and adherence to regulatory and institutional guidelines. Additional Skills & Qualifications • Experience working with clinical trial management systems and clinical trials databases., • Familiarity with oncology-specific clinical trial workflows and tumor study groups., • Experience with adverse event assessment and grading using NCI common toxicity criteria or protocol-specific scales., • Experience completing Serious/Unexpected Adverse Event (SAE) documentation for internal and multicenter trials., • Strong interpersonal skills with the ability to build effective relationships with investigators, sponsors, and internal stakeholders., • Demonstrated ability to anticipate needs, be resourceful, and maximize available resources., • Track record of holding oneself accountable to high standards of professional excellence., • Ability to seek and accept personal and professional responsibility on a continuous basis., • Comfort working in a fast-paced research environment with large enrollment volumes and multiple concurrent trials.Job Type & Location This is a Contract position based out of Livingston, NJ. Pay and Benefits The pay range for this position is $30.00 - $33.00/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 Jun 26, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. 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. 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