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Clinical Research Nurse Specialist
2 months ago
About the Role:
We are seeking a highly skilled and experienced 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.
Responsibilities:
- Assist the principal investigator in preparing proposed clinical trials by reviewing trial protocol, contacting departments, and ensuring notifications are made.
- Ensure protocol revisions, informed consents, continuing reviews, and serious adverse events are submitted to the IRB in a timely manner.
- Act as liaison between principal investigators and sub-investigators on regulatory issues and changes within the protocol.
- Interact with regulatory specialists and principal investigators on 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.
- Review study with principal investigator and/or clinical research coordinator to create 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 patient needs and modify care to meet those needs, including communicating with patients, caregivers, and healthcare providers.
- Review medical records for potential study patients and ensure documentation of laboratory test results and procedures.
- Instruct patients, caregivers, physicians, and staff on patient care, available trials, treatments, and side effects.
- Assist investigator with consent process, ensuring patients understand clinical trials and obtain written informed consent.
- Document patient medical history, including past medical/surgical treatments, significant medical conditions, and medication history.
- Perform nursing assessments and monitor patient progress during clinical trials, tracking response and documenting on toxicity flow sheets and medication flow sheets.
- Maintain accurate, complete, and up-to-date records on each patient participating in a clinical trial protocol.
- Evaluate and develop patient education materials and provide instructions on drug administration and medical information.
- Plan for patient care under the direction of a physician or advanced practice nurse.
- Notify principal investigator of adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects.
- Report serious adverse events to the 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 clinical duties, including EKGs, processing/shipping of blood serum, and communicating results to PI and/or APN.
- Review and process Safety Reports (INDs, SUGARs) as per institutional policies and procedures.
- Act as principal investigator's representative, communicating with sponsors, IRB, and other medical personnel.
- Maintain accurate, complete, and up-to-date records on each patient participating in a clinical trial protocol.
- Ensure patient 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.
- Participate in staff meetings and in-service education of nursing and medical staff.
- Other duties and/or projects as assigned.
Qualifications:
- 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.
- Excellent written and verbal communication skills.
- Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.
Preferred Qualifications:
- 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).
