Clinical Research Nurse
7 days ago
We are seeking a highly skilled Clinical Research Nurse to join our team at Hackensack Meridian Health. As a Clinical Research Nurse, you will play a critical role in coordinating and overseeing clinical research operations for all assigned clinical trials.
Key Responsibilities- Protocol Management: Assist the principal investigator in preparing proposed clinical trials by reviewing trial protocol, contacting each department who will provide resources during study, and ensuring appropriate departments are notified and given a copy of proposed trial, scientific merit, and accrual potential.
- Regulatory Compliance: Ensure that all protocol revisions, informed consents, continuing reviews, and serious adverse events are submitted to the appropriate Institutional Review Board (IRB) of record in a timely manner.
- Liaison and Communication: Act as liaison between principal investigators and sub-investigators on all regulatory issues and changes within the protocol, and interact with regulatory specialists and principal investigators and sub-investigators on all regulatory issues and changes within the protocol.
- Study Feasibility and Budgeting: In collaboration with the principal investigator, clinical research coordinator, and clinical team, participate in the review of studies for feasibility and evaluate potential competition with other protocols prior to submitting study, and review study with principal investigator and/or clinical research coordinator to a budget outlining standard of care and research costs.
- Patient Recruitment and Management: Recruit and evaluate potential study patients, and work with clinical research coordinator to schedule required appointments and interviews, and identify the needs of the patient population served and modify and deliver care that is specific to those needs.
- Medical Record Review and Documentation: Review medical records for potential study patients and ensure that medical records include documentation of all laboratory test results and procedures and progress of study patients, following guidelines set forth by the protocol sponsors.
- Patient Education and Informed Consent: Instruct potential study patients, designated caregiver, physicians, nurse clinicians, and other ancillary staff members involved in the care of the patient on aspects of patient's care, available trials, treatments, and side effects, and assist investigator with consent process assuring study patients understand clinical trials and obtain written informed consent.
- Study Patient Monitoring and Data Management: Perform nursing assessments and monitor study patient's progress during clinical trials, track study patient's response by documenting on toxicity flow sheet, medication flow sheet, and nurse's progress notes, and maintain accurate, complete, up-to-date records on each patient participating in a clinical trial protocol in all applicable systems.
- Education and Training: Evaluate and develop study patient education materials and give study patient and/or designated caregiver instructions on drug administration and other medical information, and create study-specific calendars for study patients.
- Adverse Event Reporting and Research Activities Coordination: Notify principal investigator of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects, and report all serious adverse events to sponsor and IRB of record according to established timelines, and coordinate research activities not limited to scheduling laboratory tests, radiology testing, and other medical exams.
- Regulatory and Compliance Activities: Together with the principal investigator, review and process all Safety Reports (INDs, SUGARs) as per institutional policies and procedures, and act as principal investigator's representative as appropriate, communicating with sponsors and their representatives, the IRB, and other medical personnel.
- Financial and Administrative Activities: Ensure study patient's clinical trial-related activities are billed appropriately and reconcile drug study account records with research finance personnel, and prepare and assist for sponsor monitor site visits and ensure all supporting documentation records are adequate and available for the visit.
- Professional Development and Collaboration: Participate in staff meetings and in-service education of nursing and medical staff, and attend research meetings and conferences as required, and develop case report forms and/or databases for physician-initiated studies as needed.
- Education: BSN required (Note: this applies to team members hired or transferred on or after March 31, 2024. Team members hired or transferred prior to March 31, 2024 require a minimum of an associate in Nursing or diploma of Nursing degree).
- Experience: Minimum of 3 years clinical nursing experience or 1 year of clinical nursing experience with an additional 2 years of clinical research experience.
- Skills and Abilities: Strong attention to detail and customer service focus is required, excellent communication, organizational, presentation, documentation, and interpersonal skills are required, ability to work independently, or in a team, and handle multiple deadline-driven tasks in a dynamic environment is essential, and proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.
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