Clinical Research Nurse

Description Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives and support one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Competitive benefits are just the beginning; it is also about how we support one another and show up for our community. Together we keep getting better—advancing our mission to transform healthcare and serve as a leader of positive change. The Clinical Research Nurse coordinates and oversees clinical research operations for all assigned clinical trials and participates in planning, implementing and evaluating compliant patient care in clinical research trials. The role works under the general supervision of the principal investigator. Responsibilities A day in the life of a Clinical Research Nurse at Hackensack Meridian Health includes: Assists the principal investigator in preparing proposed clinical trials by reviewing trial protocol, contacting each department that will provide resources during study, and ensuring appropriate departments are notified and given a copy of the proposed trial, scientific merit, and accrual potential. Assures that all protocol revisions, informed consents, continuing reviews, and serious adverse events are submitted to the appropriate IRB of record in a timely manner. Acts as liaison between principal investigators and sub‑investigators on all regulatory issues and changes within the protocol. Interacts with regulatory specialists and investigators on all regulatory issues and changes within the protocol. Collaborates with the principal investigator, clinical research coordinator, and clinical team to review studies for feasibility and evaluates potential competition with other protocols prior to submitting the study. Reviews study with principal investigator and/or clinical research coordinator to outline a budget highlighting standard of care and research costs, and finalizes budget draft with the budget coordinator. Recruits and evaluates potential study patients, and works with the clinical research coordinator to schedule required appointments and interviews. Identifies the needs of the patient population served and modifies and delivers care that is specific to those needs (e.g., age, culture, hearing, visual impairment, etc.), communicating with patients, parents, and primary caregivers at their level of development, education, and literacy. Reviews medical records for potential study patients, ensuring that the records include documentation of all laboratory test results, procedures, and progress of study patients in accordance with protocol sponsor guidelines. Instructs potential study patients, designated caregivers, physicians, nurse clinicians, and ancillary staff involved in patient care on aspects of patient care, available trials, treatments, and side effects. Assists investigators with the consent process, ensuring study patients understand clinical trials and obtains written informed consent. Educates study patients concerning informed consent procedures and HIPAA authorization. Documents study patients' medical history, including but not limited to past medical/surgical treatments, significant medical conditions, and medication history per protocol guidelines. Performs nursing assessments and monitors study patients' progress during clinical trials; tracks patient response by documenting on toxicity flow sheet, medication flow sheet, and nurses’ progress notes. Maintains accurate, complete, up‑to‑date records on each patient participating in a clinical trial protocol in all applicable systems (e.g., electronic medical record, clinical trial management system, departmental, and protocol‑specific databases). Evaluates and develops study patient education materials and gives patient and/or designated caregiver instructions on drug administration and other medical information; creates study‑specific calendars for patients. Plans for study patients’ appropriate care under the direction of a physician or advanced practice nurse. Notifies principal investigator of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects. Reports all serious adverse events to sponsor and IRB of record according to established timelines. Coordinates research activities, not limited to scheduling laboratory tests, radiology testing, and other medical exams. Performs and/or oversees a variety of clinical duties that may include, but not limited to, EKGs, processing/shipping of blood serum, urine, and communicates results to PI and/or APN. Together with the principal investigator reviews and processes all safety reports (INDs, SUGARs) as per institutional policies and procedures. Acts as principal investigator’s representative as appropriate, including, but not limited to, communicating with sponsors and their representatives, the IRB, and other medical personnel. Ensures study patients’ clinical trial related activities are billed appropriately and reconciles drug study account records with research finance personnel. Prepares and assists for sponsor monitor site visits, ensuring all supporting documentation records are adequate and available for the visit; meets with monitor at least once during each monitor site visit and resolves all issues found during the visit. Develops case report forms and/or databases for physician‑initiated studies as needed. Assists the principal investigator in preparing for publication, working with analysts and assisting with queries related to data to evaluate the significance of collected data. Provides education to all departments and clinical areas where the study is performed. Attends research meetings and conferences as required. Participates in staff meetings and in‑service education of nursing and medical staff. Other duties and/or projects as assigned. Adheres to HMH organizational competencies and standards of behavior. Qualifications Education, Knowledge, Skills and Abilities Required BSN required. (Note: applies to team members hired or transferred into the Clinical Research Nurse position on or after March31,2024. Team members hired or transferred prior to that date require a minimum of an associate in Nursing or diploma of Nursing degree.) Advanced master’s degree in nursing programs satisfy the BSN requirement (e.g., Associates to MSN). Minimum of 3 years clinical nursing experience or 1 year of clinical nursing experience with an additional 2 years of clinical research experience. Adherence to the American Nurses Association standards. Strong attention to detail and customer service focus. Excellent communication, organizational, presentation, documentation, and interpersonal skills. Ability to work independently or in a team, and handle multiple deadline‑driven tasks in a dynamic environment. Proficient computer skills, including but not limited to Microsoft Office and/or Google Suite platforms. Review and comply with all relevant HMH and Business Unit policies and procedures, and local, state, and federal laws and regulations. Excellent written and verbal communication skills. Education, Knowledge, Skills And Abilities Preferred National Certification in area of specialty preferred when eligible. Licenses And Certifications Required NJ State Professional Registered Nurse License. AHA Basic Health Care Life Support HCP Certification within 60 days of entering position. Licenses And Certifications Preferred Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), and/or Certified Clinical Research Coordinator (CCRC). Job Duties The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different from the posted rate of pay based on a number of non‑discriminatory factors, including but not limited to: Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness. Experience: Years of relevant work experience. Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training. Skills: Demonstrated proficiency in relevant skills and competencies. Geographic Location: Cost of living and market rates for the specific location. Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization. Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. Some jobs may also be eligible for performance‑based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts. In addition to our compensation for full‑time and part‑time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits. Minimum rate of $113,609.60 Annually. #J-18808-Ljbffr