The Coord-Research-Nursing coordinates administrative and clinical aspects of multiple research projects. Option of 4 10-hour shifts available.
Screening and consenting potential subjects for eligibility in cardiovascular clinical trials
Collect procedure data
Complete all case report forms and provide source documents
Complete required follow-up visits
Prepare for sponsor and monitoring visits
Review EMR and report adverse events
Must have excellent computer and organizational skills
Collaborates with primary investigator, sponsor and research staff to plan, conduct and evaluate project protocols. Monitors and reports on progress of projects as necessary.
Assists with the recruitment of research study participants. Manages the handling and reporting of adverse events, compliance and other participant-related issues.
Coordinates the preparation and delivery of departmental communications, presentations and marketing/educational materials.
Collaborates to ensure compliance with the quality assurance process and with applicable regulations and standards. Assists with responding to and preparing for site visits and audits.
Prepares and submits necessary documentation to the Institutional Review Board, Clinical Risk Management, study sponsors, Food and Drug Administration, and other hospital departments including outside agencies as applicable, for approval prior to initiation of study, as well as ongoing reporting throughout duration of study. Facilitates monitoring and auditing of research procedures and study data, conducted by study sponsors, contract research organizations, Food and Drug Administration, and/or other applicable organizations.
Reviews clinical site agreements (contracts) and acts as liaison between Principal Investigator, hospital administration, and study sponsors in negotiating study budgets and agreements. Acts as liaison between sponsors and the site, coordinating trial initiations, maintaining compliance with protocols and documentation, and monitoring research and ancillary staff to assure protocol compliance. Conveys pertinent information and provides necessary in-services to ancillary departments that will be impacted by study requirements.
Under direction of Principal Investigators, coordinates study procedures and maintains study documentation in accordance with International Conference on Harmonisation Good Clinical Practice (GCP) guidelines, Titles 18 and 21 of the Code of Federal Regulations, and as required by contract or other applicable statute. Responsible for the conduct of clinical studies, including subject screening and recruitment, obtaining informed consent, recording information on case report forms (data collection) and other study documents, providing study sponsors with required documentation, maintaining study records and ensuring their confidentiality, cooperating with study audits, and conduct follow up with patients and sponsors for continued acquisition.
Performs all other duties and projects as assigned.
Licensed as a Registered Nurse (RN) by the State of Michigan Board of Nursing required.
Research Coordinator Certification (CCRS) preferred.
Associate degree required Bachelor of Science in Nursing (BSN) preferred
Three (3) years of research or recent hospital experience required. Experience in externally sponsored and internally planned clinical trials preferred.
Cardiovascular experience required, previous cath lab experience or equivalent preferred
t. John Providence is committed to providing care to treat the entire person -- body, mind, and spirit. This philosophy of care underscores our heritage as a faith-based health system offering our patients so much more than medicine.
We are the largest provider of inpatient care in southeast Michigan and one of the largest employers in metro Detroit. St. John Providence provides comprehensive p...revention, primary care, and advanced treatment programs with more than 125 medical centers and four hospitals spanning four counties. Our Centers of Excellence offer expertise in cancer, heart and vascular, minimally invasive surgery, neuroscience, orthopedics, and weight loss.
We believe that good health is the cornerstone of progress. We are firm in our resolve to make exemplary health care accessible and affordable to all, dedicated to lowering the high rate of cardiovascular disease, including stroke, in minority populations and committed to advocacy and diversity. We are guided by ethical principles in all transactions and strive for excellence in our training and skills.