Clinical Research Nurse
4 weeks ago
The Clinical Research Nurse is a key member of our team, responsible for coordinating and overseeing clinical research operations for all assigned clinical trials. This role requires strong attention to detail, excellent communication and organizational skills, and the ability to work independently or as part of a team.
Key Responsibilities- Coordinate and oversee clinical research operations for all assigned clinical trials
- Assist the principal investigator in preparing proposed clinical trials, including reviewing trial protocol and contacting relevant departments
- 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
- Recruit and evaluate potential study patients, and work with clinical research coordinators 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 all laboratory test results and procedures
- Instruct potential study patients, designated caregivers, physicians, and other ancillary 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
- Document study patient medical history, including past medical/surgical treatments, significant medical conditions, and medication history
- Perform nursing assessments and monitor study patient 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 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 various clinical duties, including EKGs, processing/shipping of blood serum, and communicating results to PI and/or APN
- Review and process all Safety Reports (INDs, SUGARs) as per institutional policies and procedures
- Act as principal investigator's representative as appropriate, communicating with sponsors and their representatives, the IRB, and other medical personnel
- Ensure study patient 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 study is performed
- Attend research meetings and conferences as required
- BSN required
- 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
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Clinical Research Nurse
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