Oncology Clinical Research Nurse Solid Division F/T
2 weeks ago
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 operations of clinical trials, and participating in assessing, planning, implementing, and evaluating compliant patient care in clinical research studies.
Key Responsibilities- Assist the principal investigator in preparing proposed clinical trials by reviewing trial protocol, contacting departments, and ensuring notifications and copies are distributed.
- Ensure timely submission of protocol revisions, informed consents, continuing reviews, and serious adverse events to the IRB of record.
- 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 with other protocols.
- Review studies with the 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 the 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 documentation of laboratory test results and procedures.
- Instruct potential study patients, caregivers, physicians, and staff on aspects of patient care, available trials, treatments, and side effects.
- Assist the investigator with the consent process, ensuring study patients understand clinical trials and obtain written informed consent.
- Document study patients' medical history, including past medical/surgical treatments, significant medical conditions, and medication history.
- Perform nursing assessments and monitor study patients' progress during clinical trials.
- Maintain accurate, complete, and up-to-date records on each patient participating in a clinical trial protocol.
- Evaluate and develop study patient education materials and give instructions on drug administration and other medical information.
- Notify the 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 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 the PI and/or APN.
- Review and process Safety Reports (INDs, SUGARs) as per institutional policies and procedures.
- Act as the principal investigator's representative, communicating with sponsors, the IRB, and other medical personnel.
- Ensure study patients' 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 the study is performed.
- Attend research meetings and conferences as required.
- Participate in staff meetings and in-service education of nursing and medical staff.
- 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.
- NJ State Professional Registered Nurse License.
- AHA Basic Health Care Life Support HCP Certification within 60 days of entering position.
- 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.
- National Certification in area of specialty preferred when eligible.
- Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC) preferred.
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Hackensack, New Jersey, United States HACKENSACK UNIVERSITY MED CNTR Full timeAbout UsHackensack University Medical Center is a leading healthcare provider in the region, committed to delivering exceptional patient care and advancing medical research.Job SummaryThe Oncology Clinical Research Nurse Solid Division is a critical role in our team, responsible for coordinating and overseeing clinical operations of clinical trials. As a...
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Hackensack, New Jersey, United States HACKENSACK UNIVERSITY MED CNTR Full timeAbout UsHackensack University Medical Center is a leading healthcare provider in the region, dedicated to delivering exceptional patient care and advancing medical research.Job SummaryWe are seeking a highly skilled Clinical Research Nurse to join our Oncology Solid Division team. The successful candidate will be responsible for coordinating and overseeing...
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Hackensack, New Jersey, United States HACKENSACK UNIVERSITY MED CNTR Full timeJob SummaryThe Oncology Clinical Research Nurse Solid Division is a key member of the Hackensack University Medical Center team, responsible for coordinating and overseeing clinical operations of a clinical trial. This role participates in assessing, planning, implementing, and evaluating compliant patient care in clinical research studies.Key...
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Hackensack, New Jersey, United States HACKENSACK UNIVERSITY MED CNTR Full timeJob SummaryThe Oncology Clinical Research Nurse Solid Division is a key member of the Hackensack University Medical Center team, responsible for coordinating and overseeing clinical operations of a clinical trial. This role participates in assessing, planning, implementing, and evaluating compliant patient care in clinical research studies.Key...
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Hackensack, New Jersey, United States Hackensack Meridian Health Full timeAbout the Role We are seeking a highly skilled and experienced Clinical Research Nurse to join our team in the Oncology Solid Division. As a key member of our research team, you will play a critical role in coordinating and overseeing clinical operations of clinical trials, and participating in assessing, planning, implementing, and evaluating compliant...
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Hackensack, New Jersey, United States Hackensack Meridian Health Full timeJob Summary 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, assessing, planning, implementing, and evaluating compliant patient care in clinical research studies.The ideal...
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Hackensack, New Jersey, United States Hackensack Meridian Health Full timeAbout the RoleWe are seeking a highly skilled and experienced Clinical Research Nurse to join our team at Hackensack Meridian Health. As a key member of our clinical research team, 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...
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