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Oncology Clinical Research Nurse Solid Division F/T
1 month ago
We are seeking a highly skilled Clinical Research Nurse to join our team in the Oncology Solid Division. The successful candidate will be responsible for 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 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 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 ancillary staff on 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.
- Educate study patients on informed consent procedures and HIPAA authorization.
- 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 provide instructions on drug administration and medical information.
- Plan for study patients' appropriate care under the direction of a physician or advanced practice nurse.
- 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.
- 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 and work with analysts 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.
- Perform other duties and/or projects as assigned.
- 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.
