Clinical Research Nurse
2 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 operations of clinical trials, ensuring the highest level of patient care and compliance with regulatory requirements.
Key Responsibilities- Assist the principal investigator in preparing proposed clinical trials, reviewing trial protocol, and ensuring appropriate departments are notified and given a copy of proposed trial.
- Ensure all protocol revisions, informed consents, continuing reviews, and serious adverse events are submitted to the appropriate IRB of record in a timely manner.
- Act as liaison between principal investigators and sub-investigators on all regulatory issues and changes within the protocol.
- Interact with regulatory specialists and principal investigators and sub-investigators on all regulatory issues and changes within the protocol.
- Collaborate with the principal investigator, clinical research coordinator, and clinical team to review studies for feasibility and evaluate potential competition with other protocols prior to submitting study.
- Review study with principal investigator and/or clinical research coordinator to a budget outlining standard of care and research costs.
- Recruit and evaluate potential study patients, and work with clinical research coordinator to schedule required appointments and interviews.
- Identify the needs of the patient population served and modify and deliver care that is specific to those needs.
- 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.
- 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.
- Assist investigator with consent process, ensuring study patients understand clinical trials and obtain written informed consent.
- Educate study patients concerning informed consent procedures and HIPAA authorization.
- Document study patient's medical history, including past medical/surgical treatments, significant medical conditions, and medication history per protocol guidelines.
- 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 nurses' progress notes.
- Maintain accurate, complete, up-to-date records on each patient participating in a clinical trial protocol in all applicable systems.
- Evaluate and develop study patient education materials and give study patient and/or designated caregiver instructions on drug administration and other medical information.
- Plan for study patient's appropriate care under the direction of a physician or advanced practice nurse.
- Notify 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 sponsor and IRB of record according to established timelines.
- Coordinate research activities, including scheduling laboratory tests, radiology testing, and other medical exams.
- Perform and/or oversee a variety of clinical duties, including EKGs, processing/shipping of blood serum, and communicating results to PI and/or APN.
- Together with the principal investigator, review and process all Safety Reports (INDs, SUGARs) as per institutional policies and procedures.
- Act as principal investigator's representative as appropriate, communicating with sponsors and their representatives, the IRB, and other medical personnel.
- Maintain accurate, complete, up-to-date records on each patient participating in a clinical trial protocol.
- Ensure study patient's 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 for the visit.
- Develop case report forms and/or databases for physician-initiated studies as needed.
- Assist the principal investigator in preparing for publication, working with analysts and assisting with queries related to data to evaluate the significance of collected data.
- Provide education to all departments and clinical areas where study is performed.
- Attend research meetings and conferences as required.
- 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).
- Minimum of 3 years clinical nursing experience or 1 year of clinical nursing experience with an additional 2 years of clinical research experience.
- Adheres to the American Nurses Association standards.
- 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.
- Proficient computer skills that include but are 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.
- National Certification in area of specialty preferred when eligible.
- Licenses and Certifications Required: NJ State Professional Registered Nurse License, BLS/CPR certification by American Heart Association is required within 60 days of hire.
- Licenses and Certifications Preferred: Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).
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