Clinical Research Nurse
2 weeks ago
We are seeking a highly skilled Clinical Research Nurse to join our team at Hackensack Meridian Health. The successful candidate will be responsible for coordinating and overseeing clinical research operations for all assigned clinical trials, working under the general supervision of the principal investigator.
Key Responsibilities- Assist the principal investigator in the preparation of 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.
- Assure that 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.
- 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, following guidelines set forth by the protocol sponsors.
- 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, assuring study patients understand clinical trials and obtain written informed consent.
- Educate study patients concerning informed consent procedures, HIPAA authorization.
- Document study patient's medical history, including but not limited to 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, urine, 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, including 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.
- Meet with monitor at least once during each monitor site visit and resolve all issues found during 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.
- Adhere to HMH Organizational competencies and standards of behavior.
- 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.
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