Clinical Research Nurse Coordinator
6 days ago
Job Description
The primary purpose of the Clinical Research Nurse (CRN) is to ensure the successful, patient-oriented, safe, and effective conduct of clinical trials. The CRN 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. The CRN 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 new clinical trial protocols.
- Prepare and 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 feedback to identify and resolve potential obstacles to safe, effective study conduct.
- Perform one-on-one or group protocol-related nursing education 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 pre-screening of potential subjects and active cancer patients for available clinical trials.
- Review patient charts and medical history to confirm protocol eligibility and obtain necessary source documents.
- Follow the required elements of the informed consent process to ensure IRB-approved informed consent has been obtained.
- Provide backup support to register consented research patients with study sponsors and input data into the clinical trials database.
- Serve as a resource for Clinical Trial Billing Information related to assigned studies.
- Act as an essential link between patients and other members of the research team.
- Identify, address, and communicate challenges with protocol procedures and timelines to the study team and supervisor.
- Ensure protocol-specific orders are executed accurately, including scheduling and completion of tests and appointments.
- Coordinate protocol-specified procedures and treatments between disciplines and sites of care.
- Manage patient reimbursement while on clinical trial.
- Deliver high-quality, compassionate oncology nursing care in coordination with the assigned clinical team, investigators, and ancillary departments.
- Provide nursing assessment of study patients and ensure complete and accurate nursing documentation for protocol-specified visits.
- Collaborate with all integrated medical system staff to ensure timely delivery of services to patients.
- Grade adverse events accurately using protocol-referenced criteria and provide informal teaching to clinicians on toxicity assessment grading.
- Complete Serious/Unexpected Adverse Event (SAE) forms and ensure accurate completion of follow-up reports.
- Assess overall protocol compliance and assist with deviation reporting.
- Collaborate with the Clinical Trial Lab (CTL) to ensure proper collection and processing of bio-specimens according to protocol guidelines.
- Assist with monitoring visits, audits, and sponsor queries.
- Help the clinical study team complete Case Report Forms (CRFs) and resolve database queries.
- Maintain research records for screened and enrolled patients.
- Strive to grow professionally through continuing education and skill-building activities.
- Provide training, orientation, and preceptorship to other faculty and staff as needed.
- Ensure all appropriate regulations are followed throughout the research project.
- Maintain up-to-date knowledge of policies, procedures, guidance, and practice standards.
- 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 (Word, Excel, etc.).
- Excellent communication and interpersonal skills.
- Comfortable communicating with patients.
- Experience in clinical research coordination and patient screening.
- Ability to maximize resources and be resourceful.
- Equivalent education, experience, and/or training may be substituted for the degree requirement.
Our vision is to be a leader in scientific discovery, patient care, and education, improving outcomes for cancer patients and populations. We conduct innovative basic, clinical, and population research and provide cutting-edge patient-centered care. Our team includes 40 Clinical Operations FTEs across various disease-specific groups, 100 total FTEs, and a large network of sites across the state. With approximately 300 active trials and 5,000 subjects enrolled annually, we aim to expand our understanding of cancer and develop better therapies to decrease suffering and mortality.
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
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.
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