Clinical Research Nurse is responsible for coordinating and overseeing clinical operations of clinical trials. The role involves assessing, planning, implementing, and evaluating patient care in clinical research studies. The Clinical Research Nurse works under the supervision of the principal investigator responsible for the clinical trials. Responsibilities include:
- Assist the principal investigator in the preparation of proposed clinical trials by reviewing trial protocol and ensuring appropriate departments are notified.
- Ensure all protocol revisions, informed consents, continuing reviews, and serious adverse events are submitted to the appropriate IRB in a timely manner.
- Act as liaison between principal investigators and sub-investigators on all regulatory issues and changes within the protocol.
- In collaboration with the principal investigator, review studies for feasibility and evaluate potential competition with other protocols before submission.
- Review study with principal investigator to outline a budget and finalize it with the budget coordinator.
- Recruit and evaluate study patients, schedule appointments, and conduct interviews.
- Identify the needs of the patient population served and modify care delivery to meet those needs.
- Review medical records for potential study patients and ensure all laboratory test results and procedures are documented.
- Instruct potential study patients, designated caregivers, physicians, and other staff members on aspects of patient 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 about informed consent procedures and HIPAA authorization.
- Document study patients' medical histories, perform nursing assessments, and monitor their progress during clinical trials.
- Evaluate and develop study patient education materials and provide instructions on drug administration and other 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 or serious adverse events, including drug toxicity or unexpected side effects.
- Report all serious adverse events to the sponsor and IRB according to established timelines.
- Coordinate research activities, including scheduling laboratory tests, radiology testing, and other medical exams.
- Perform and/or oversee clinical duties such as EKGs, processing/shipping of blood serum, urine, and communicating results to the PI or APN.
- Act as the principal investigator's representative when 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 patients' clinical trial-related activities are billed appropriately and reconcile drug study account records with research finance personnel.
- Prepare and assist with sponsor monitor site visits, ensuring all supporting documentation records are adequate and available.
- 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 on data queries.
- 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.
- Adhere to the standards identified in the Medical Center's Organizational Competencies.
Essential Skills include:
- Clinical Research Experience (minimum of 2 years)
- New York Registered Nurse License
Additional Skills & Qualifications include:
- Oncology Certified Nurse (OCN) certification is a plus
- Experience in a high-volume and high-pressure environment
- Ability to work effectively in a diverse team
- Strong communication and organizational skills
Work Environment is fast-paced and requires the ability to handle high volumes and pressure effectively. The team is diverse and supportive, and the role offers flexible work hours, typically consisting of four 10-hour days from 8 AM to 6 PM or 9 AM to 7 PM. The job involves standing for a minimum of 6 hours a day and occasionally lifting, pushing, and pulling a minimum of 5 lbs.