We are seeking a dedicated Clinical Research Nurse to join our team. In this role, you will coordinate and oversee clinical operations of clinical trials, while participating in assessing, planning, implementing, and evaluating patient care in clinical research studies. You will work under the general supervision of the principal investigator responsible for the clinical trials.
ResponsibilitiesAssist the principal investigator in the preparation of proposed clinical trials by reviewing trial protocol and ensuring appropriate departments are notified.Submit protocol revisions, informed consents, continuing reviews, and serious adverse events to the appropriate IRB of record in a timely manner.Act as a liaison between principal investigators and sub-investigators on regulatory issues and protocol changes.Collaborate with the principal investigator to review studies for feasibility and evaluate potential competition with other protocols.Review studies with the principal investigator to create a budget outlining standard care and research costs, and finalize with the budget coordinator.Recruit and evaluate study patients, schedule appointments, and conduct interviews.Identify and address the specific needs of the patient population served, including age, culture, and sensory impairments.Review medical records for potential study patients and ensure documentation of all laboratory test results and procedures.Instruct potential study patients, designated caregivers, physicians, nurse clinicians, and other staff on aspects of patient care, available trials, treatments, and side effects.Assist investigators with the consent process, ensuring study patients understand clinical trials and obtain written informed consent.Educate study patients about informed consent procedures and HIPAA authorization.Document study patients' medical history, including past medical/surgical treatments, significant medical conditions, and medication history per protocol guidelines.Perform nursing assessments and monitor study patients' progress during clinical trials.Evaluate and develop study patient education materials, and provide instructions on drug administration and other medical information.Plan for study patients' appropriate care under the direction of a physician or advanced practice nurse.Notify the principal investigator of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects.Report all serious adverse events to sponsors and the IRB of record according to established timelines.Coordinate research activities, including scheduling laboratory tests, radiology testing, and other medical exams.Perform and/or oversee clinical duties such as EKGs and processing/shipping of blood serum and urine, and communicate results to the principal investigator and/or advanced practice nurse.Act as the principal investigator's representative when appropriate, including communicating with sponsors, the IRB, and other medical personnel.Maintain accurate, complete, up-to-date records on each patient participating in a clinical trial protocol.Ensure study patients' clinical trial-related activities are billed appropriately and reconcile drug study account records with research finance personnel.Prepare and assist for sponsor monitor site visits and ensure all supporting documentation records are adequate and available.Develop case report forms and/or databases for physician-initiated studies as needed.Assist the principal investigator in preparing for publication and work with analysts to evaluate the significance of collected data.
Essential SkillsGraduate of a NLN/AACN accredited program in nursing3-5 years of clinical nursing experienceMandatory education on human subjects researchNJ State Professional Registered Nurse LicenseBSN preferredExperience with FDA regulatory, IND reporting, and Microsoft or similar Office SuiteClinical research experienceWork Environment
The work environment is fast-paced, high volume, and high pressure. The role requires flexibility, with most employees working four 10-hour days from 7 AM to 6 PM, allowing for a range of start times in coordination with the rest of the staff. For the first 90 days, the schedule is Monday through Friday with an 8-hour shift. Post 90 days, employees transition to a 4-day schedule based on coverage and tenure. The team is diverse, accepting, and quickly embraces other hard workers. The role involves physical demands, including lifting a minimum of 5 lbs., pushing and pulling a minimum of 5 lbs., and standing for a minimum of 6 hours a day.
Pay and BenefitsThe pay range for this position is $100000.00 - $120000.00/yr.
We are a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care.
Workplace Type
This is a fully onsite position in hackensack,NJ.
Application Deadline
This position is anticipated to close on Mar 12, 2025.
About Actalent
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