Posting ID : A1068507168
Date Posted : 2015-08-19
Category : Healthcare
Collaborates regularly with the program Medical Director to define the overall program strategy and objective.
Consults with the program Medical Director for all matters regarding Clinical Research including, but not limited to, selection of clinical trials and regular program Quality Reviews.
Develops, modifies and maintains Standard Operating Procedures for the Clinical Research program.
Commits all research efforts exclusively to Sierra Nevada Nephrology Consultants' Clinical Research Program.
Trains all involved clinical and research staff on study protocols.
Organizes and directs work flow of clinical research study coordinators and other clinical research staff while mentoring and fostering a professional growth and learning rich environment.
In cooperation with Administration, participates in all areas of staff recruitment, performance reviews, and progressive discipline.
Works to ensure rapid subject recruitment, educating clinic staff and providers about the clinical trials as well as specific inclusion/exclusion criteria.
Strategizes practice wide recruitment plans in conjunction with Program Medical Director and Administrative Executives.
Ensures program adherence to Good Clinical Practices and study protocols
Protects the scientific integrity of data and protects the rights, safety, and well-being of subjects
Discusses study protocols with patients and obtains or delegates the informed consent and documentation process
Dispenses study medication per protocol requirements
Directly or indirectly ensures case report forms are completed and maintained per FDA guidelines reviewing against the patient's medical record for completeness and accuracy
Ensures adverse events (AE's) are properly documented and reported
Screens all laboratory results and reviews for clinical significance
Performs the collection, preparation and distribution of information, maintain integrity and quality of research data, patient enrollment process, data analysis for various medical publications & reports, protocol implementing, research data base management, & IRB submission
Acts as the primary professional liaison between SNNC and Pharmaceutical Companies
Reports regularly to Administrative Executives and the Executive Board of the Board of Directors regarding program status, direction, and general needs
Demonstrates adherence to SNNC's policies and procedures
Plays an active role in promoting quality patient care and overall practice success
Work closely with Physicians, Ancillary Staff Members, and Management to improve patient care and outcomes
Establish and maintain professional community relationships with outside clinics/hospitals and physicians/physician offices as necessary
Work with Administrative Executives to set and achieve goals for productivity and performance
Provide leadership/mentor support for clinical staff as needed
Demonstrate professionalism at all times, promoting a friendly work environment and providing excellent customer service
Bachelor's degree or equivalent combination of education/experience in science or health-related field required. Advanced degree desirable. Must have the ability to work in a fast paced environment; excellent communication and computer skills; 3 + years of experience in medical pharmaceutical industry with at least 2 years of hands-on managerial experience running clinical trials and managing teams. Nephrology experience preferred.
Experience with all aspects of management of large clinical trials from inception to completion.
Strong knowledge of FDA regulations and experience with a variety of Clinical Trials
Previous clinical trial site management experience preferred
Strong MS Office skill, and meticulous attention to detail
Knowledge of study accounting
Knowledge of and experience in experimental design
Basic understanding of statistics and statistical methods
Knowledge of Good Clinical Practice (CGP)
Knowledge of HR practice and requirements
This is a full time position. Benefits package will be available after appropriate amount of time. If interested please submit your resume via email by using the RenoTahoeJobs.com link below: