Clinical Research Nurse
2 months ago
The Clinical Research Nurse is responsible for assisting in data collection and analysis specific to clinical research trials. Working under close supervision, the Clinical Research Nurse I supports the research team and occasionally performs some patient-related care and assessments within the scope of their licensure.
Talent Pool: Nursing
Reviews patient cases, medical histories, and current treatment plans to effectively recruit and enroll potential research subjects that are actively engaged in the informed consent process.
Supports the regulatory process in the submission of study protocols, consent forms, and recruiting materials to the Institutional Review Board and the department for approval, facilitating the regulatory compliance necessary for research projects in the hospital/medical group setting.
Serves as study coordinator for pharmaceutical and/or device trials, successfully coordinating site initiation visits, monitoring visits, and close-out visits, and ensuring adherence to protocol guidelines and regulatory requirements.
Helps coordinate activities for multiple simultaneous clinical trials, managing various research tasks efficiently, ensuring optimal use of resources and executing research protocols in a timely manner.
Corresponds with healthcare teams, providers, outside research partners, and patients, ensuring clear communication and continuity of care for patients.
Assists with the maintenance of records of patient interactions and clinical research interventions to ensure consistent and coordinated care, including collaborating with Investigator in assessment and management of Adverse Events.
Completes clinical tasks within the scope of nursing license to meet patients' immediate needs as necessary.
Performs other duties as assigned. EDUCATION:Required:
Graduate of a School of Nursing. Associates Degree, Nursing
Preferred:
Bachelor Degree, Nursing
EXPERIENCE:Required: One year of clinical experience in related therapeutic area.
LICENSURE/CERTIFICATION/REGISTRY/LISTING:REQUIRED
1. Technical skills related to the completion of a study visit as required by the protocol.
2. Computer Competency including proficiency in Microsoft Office and EDC systems
3. State of North Carolina nursing licensure is required
Obtain Good Clinical Practice certification within 30 days of hire and maintain without lapse.
Obtain Human Subjects Research certification within 30 days of hire and maintain without lapse.
PREFERRED
1. Understanding of ICH/GCP guidelines for human research
2. Understanding of Code of Federal Regulations for Human Subjects
3. Understanding Phases I-IV drug development processes
4. Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) is preferred.
Preferred: 1 year in a clinical specialty as defined by ANCC or national nursing organizations
LICENSURE/CERTIFICATION/REGISTRY/LISTING:
Required:
Registered Nurse license in North Carolina or a Compact state
BLS (CPR)-American Red Cross or AHA Healthcare Provider
Equal Opportunity Employer At Cone Health, we strive to create a welcoming atmosphere that celebrates a diverse and unique workforce. We believe in offering equal opportunities for employment to all applicants and employees, regardless of their race, religion, age, sex, sexual orientation, gender identity, veteran's status, ethnicity, national origin, disability, color, or any other characteristic protected by law. Our hiring and employment choices are based on each individual's qualifications, skills and performance. We believe that by embracing the diversity of our team, we can better serve our patients, communities and each other.
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