Job Title: Clinical Research Nurse Job Description The primary purpose of the Clinical Research Nurse is to ensure the successful, patient-oriented, safe, and effective conduct of clinical trials. The Research Nurse Clinician assists investigators in preparing and implementing new clinical trials, screens and enrolls study participants, and provides protocol-related clinical management to those participants while on study. This role also serves as a resource to other faculty and staff on available protocols and general research topics, such as FDA, IRB, and GCP regulations. Responsibilities + Collaborate with the Protocol Activation office to initiate and activate all new clinical trial protocols assigned, utilizing the study start-up task list. + Prepare and/or review study tools such as study binders, medication diaries, eligibility checklists, and flow sheets. + Verify Scientific Review Board (SRB), Institutional Review Board (IRB), data collection plans, and finance/contract approvals prior to study activation. + Review protocols and collect multidisciplinary logistical, educational, and financial feedback to identify potential obstacles to safe, effective study conduct. + Perform one-on-one or group protocol-related nursing education to other disciplines to facilitate safe, effective care of enrolled patients. + Translate finalized protocol treatment plans, study calendars, and clinical trials billing grids into sample orders. + Collaborate with the clinical research team to ensure timely prescreening of potential subjects and active cancer patients for all available clinical trials. + Review patient charts and medical history to confirm protocol eligibility and obtain source documents as needed. + Follow the required elements of the informed consent process to ensure that IRB-approved informed consent has been obtained, signed, placed in the medical record, and a copy provided to the patient. + Obtain informed consent for both therapeutic and non-therapeutic studies as assigned in accordance with IRB, GCP, and institutional policies and procedures. + Provide back-up support to register consented research patients with study sponsors and input data into the clinical trials database. + Provide completed precertification forms and anticipated clinical information to the Financial Counselor. + Serve as a resource for Clinical Trial Billing Information related to assigned studies as per the billing grid. + Serve as an essential link between patients and all other members of the research team. + Identify, address, and communicate any challenges with protocol-required procedures and/or adherence to protocol timelines to the study team and supervisor. + Ensure protocol-specific orders are entered and executed accurately, including scheduling and completion of tests and appointments. + Coordinate continuity of protocol-specified procedures and/or treatments for study patients between disciplines/sites of care. + Coordinate patient reimbursement while on clinical trial, including issuing study-specific ClinCards. + Manage, coordinate, and deliver high-quality, compassionate oncology nursing care and ensure adherence to the treatment plan and GCP guidelines. + Provide nursing assessment of study patients by phone or in person and route patients as indicated to meet additional or urgent care needs. + Provide complete and accurate nursing documentation for protocol-specified visits and ensure reconciliation of concomitant medications for patients on active study treatment. + Drive collaboration with all integrated academic medical system staff to ensure timely delivery of services to patients. + In collaboration with the physician, accurately grade adverse events using protocol-referenced grading scales to document toxicities and provide informal teaching/coaching to clinicians. + Complete Serious/Unexpected Adverse Event (SAE) forms and ensure accurate completion of SAE follow-up reports. + Assist with monitoring visits and audits as requested and provide accurate, timely responses to sponsor queries. + Assist the clinical study team to complete Case Report Forms (CRFs) and/or resolve database queries as needed. + Maintain research records for screened and enrolled patients. + Maintain a high level of professional responsibility and performance. + Strive to grow professionally through continuing education and skill building. + Demonstrate competence in utilizing computerized systems required for the role. + Attend training programs, modules, workshops, and seminars sponsored by the organization. + Provide training, orientation, and preceptorship to other faculty and staff as needed. + Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project. + Maintain up-to-date knowledge and adhere to policies, procedures, guidance, and practice standards set by regulatory bodies. Essential Skills + Graduate of an accredited school of nursing with a license to practice in the State of New Jersey. + Bachelor’s Degree in Nursing preferred. + One (1) year of oncology experience required. + Three (3) to five (5) years of oncology research experience preferred. + Active Basic Life Support (BLS) certification. + Oncology Nursing Society (ONS) certification as an Oncology Certified Nurse (OCN) or Advanced Oncology Certified Nurse (AOCN) preferred. + Association of Clinical Research Professional as a Clinical Research Analyst (CRA) or Society of Clinical Research Associates (SoCRA) certification as a Clinical Research Professional (CCRP) preferred. + Detail-oriented with excellent organizational skills. + Proficient in computer applications such as the person, Word, and Excel. + Excellent communication and interpersonal skills. + Ability to maximize resources and be resourceful. Additional Skills & Qualifications + Experience and comfort in communicating with patients. + Experience in screening and coordinating study patients. + Knowledge of clinical research coordinator duties. + Familiarity with clinical research, oncology, and informed consent processes. Pay and Benefits The pay range for this position is $55.00 - $57.00/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 Newark,NJ. Application Deadline This position is anticipated to close on Feb 7, 2025. 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.