Clinical Research Nurse

Description

• Document study patients' medical history per protocol guidelines.
• Instruct potential study patients and staff on aspects of patient care, available trials, treatments, and side effects.
• Ensure clinical trial-related activities are billed appropriately and reconcile drug study account records.
• Prepare and assist for sponsor monitor site visits, ensuring adequate supporting documentation records.
• Review medical records for potential study patients and ensure documentation of all laboratory test results and procedures.
• Identify and modify care to meet the needs of the patient population, considering age, culture, and other specific needs.
• Assist the principal investigator in preparing for publication and work with analysts to evaluate data.
• Perform nursing assessments and monitor study patients' progress during clinical trials.
• Provide education to all departments and clinical areas where the study is performed.
• Act as the principal investigator's representative in communication with sponsors, IRB, and medical personnel.
• Recruit and evaluate study patients, schedule appointments and interviews.
• Perform and oversee clinical duties such as EKGs and processing/shipping of blood serum and urine.
• Attend research meetings and conferences as required.
• Assist the principal investigator in preparing proposed clinical trials by reviewing trial protocols and coordinating with departments.
• Evaluate and develop study patient education materials and provide instructions on drug administration.
• Plan for study patients' appropriate care under physician or advanced practice nurse direction.
• Act as a liaison between principal investigators and sub-investigators on regulatory issues and protocol changes.
• Collaborate with the principal investigator to review studies for feasibility and evaluate potential competition with other protocols.
• Educate study patients on informed consent procedures and HIPAA authorization.
• Notify the principal investigator of any adverse events and report all serious adverse events to the sponsor and IRB.
• Adhere to the standards identified in the Medical Center's Organizational Competencies.
• Ensure timely submission of all protocol revisions, informed consents, continuing reviews, and serious adverse events to the appropriate IRB.
• Coordinate research activities, including scheduling laboratory tests and other medical exams.
• Participate in staff meetings and in-service education of nursing and medical staff.
• Maintain accurate, complete, and up-to-date records on each patient participating in a clinical trial protocol.
• Develop case report forms and/or databases for physician-initiated studies.
• Assist with the consent process, ensuring study patients understand clinical trials and obtain written informed consent.

Requirements

• BSN preferred.
• Graduate of a NLN/AACN accredited program in nursing.
• Oncology or clinical research experience.
• Proficiency in Microsoft or similar Office Suite.
• Adherence to the American Nurses Association standards.
• Clinical Research Experience or Oncology Certified Nurse (OCN) with 2-5 years of experience.
• 3-5 years of clinical nursing experience.
• Experience with FDA regulatory and IND reporting.
• NJ State Professional Registered Nurse License.

Benefits

• Mandatory education on human subjects research.

Training + Development

Interview process

Visa Sponsorship

Security clearance