Responsible for assisting with
implementation and coordination of the cardiology based clinical research trials at St. Anthony's
. Assures clinical trials are conducted according to GCP, IRB and FDA guidelines, adhering to all requirements for clinical trial conduct.
Position coordinates directly with health professionals, sponsor representatives, Institutional Review Board personnel and patients participating in clinical research protocols to assure proper conduct and compliance of the clinical trials.
Assists and educates medical personnel regarding the study protocols.
Works autonomously to complete regulatory document preparation and submission to sponsor and IRB, attend trial initiation and follow-up meetings, assess eligibility of potential participants, enroll eligible patients and perform follow-up visits for all enrolled subjects. Performs all visits appropriately in the specified time frame, abstracts and submits accurate study data and completes case report forms for all enrolled patients. Demonstrates decision making skills in patient physical and psychological assessment to determine if further physician assessment is required. Demonstrates meticulous attention to details and excellent communication and problem solving skills to coordinate a variety of clinical trials concurrently. Financial responsibilities include assisting lead coordinator in reviewing study budgets and tracking reimbursement for study visits.
Maintains patient rights and confidentiality of patient information.
Performs duties and responsibilities in a manner consistent with our mission, values and guiding principles.
Must be a graduate of an accredited school of nursing with current active Missouri Nursing license.
A minimum of five years Medical Surgical Nursing experience is required.
Previous research experience preferred.
Clinical Research Coordinator Certification is preferred.
Proficiency in Microsoft Word, Microsoft Excel and web based data electronic data entry required.
St. Anthony's Medical Center
- 2 years ago - save job