Research Specialist, MCVI Research, FT, 8A-4:30P
About The Position
As directed by the Supervisor of Clinical Research, the Research Specialist supports the professional role of the Clinical Research staff at the Cardiac and Vascular Institute (MCVI) by coordinating and administering the clinical study protocols (CSP) in cooperation with the Principal Investigator. Reviews studies and suggest methodologies for enrollment of patients. Perform functions as required by the CSP making sure all regulatory and protocol requirements are met. Must be able to complete detailed paperwork in strict accordance with study specific requirements and all federal and regulatory guidance's, while organizing tactical interventions that maximize subject finding, participation, enrollment and retention for cardiovascular research protocols in cooperation with the principal investigators. Performs those functions required by the research director to enroll patients in research protocol within a regulatory framework in accordance with IRB requirements and good clinical practices. Serves as a research advocate to ensure that all enrollment requirements are met while abiding by regulatory requirements and maintaining research protocol demands. Deal with physicians, patients, sponsors and other departments in a service oriented, excellent manner.
Requirements
- Doctor of Medicine / DO.
- Collab Inst Training Init.
- Physician with advanced Cardiovascular knowledge base and clinical research experience to implement the operational aspects of research investigations in the field of cardiology, vascular medicine, cardio-thoracic surgery, interventional radiology and interventional cardiology.
- Strong clinical background in critical care/cardiac/cath lab with experience in quality monitoring, and/or research methodology.
- Ability to manage implementation of multiple study protocols/projects systematically.
- Excellent interpersonal collaborative and team building skills.
- Must be able to work in highly stressful environments and high volume areas with multi-tasking to ensure enrollment of patients in accordance with regulatory requirements.
- Must be able to communicate in Spanish and English is preferred.
- Complete detailed paperwork in strict accordance with regulatory requirements and deal with physicians, patients, sponsors and other departments in a service excellence manner.
- Skills in using word processing and spreadsheet software.
- Knowledge of Research Guidelines and Regulatory Requirements, FDA, NIH, OHRP and the Code of Federal Regulations.
- Minimum Required Experience: 1 Year
Nice To Haves
- Clinical Study Coordinator Certification Preferred.
Responsibilities
- Coordinate and administer clinical study protocols (CSP) in cooperation with the Principal Investigator.
- Review studies and suggest methodologies for enrollment of patients.
- Perform functions as required by the CSP, ensuring all regulatory and protocol requirements are met.
- Complete detailed paperwork in strict accordance with study specific requirements and all federal and regulatory guidance's.
- Organize tactical interventions that maximize subject finding, participation, enrollment and retention for cardiovascular research protocols.
- Perform functions required by the research director to enroll patients in research protocols within a regulatory framework in accordance with IRB requirements and good clinical practices.
- Serve as a research advocate to ensure all enrollment requirements are met while abiding by regulatory requirements and maintaining research protocol demands.
- Deal with physicians, patients, sponsors and other departments in a service-oriented, excellent manner.
Benefits
- Career growth and development opportunities, with clear pathways and ongoing support
- Comprehensive health and wellness resources that go beyond traditional benefits
- A wellness program that can help employees eliminate their medical plan deductible, reducing out-of-pocket healthcare costs
- Tuition reimbursement to support continued learning and advancement
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
