Manager of Clinical Research and Patient Outcomes (Orthopaedics) 16821
The Department of Orthopaedics at West Virginia University is seeking applications for a Manager of Clinical Research and Patient Outcomes. This position manages all aspects of clinical research from project proposal, Institutional (IRB) approval, study initiation, data analysis and close out.
In order to be successful in this position, the ideal candidate will:
Collaborates with Director of Clinical Research to define strategic goals and works with Principal Investigators and staff to achieve project goals. Develops management reports to support budgeting and resource allocation forecasting.
Supervises daily research activities of the research support staff including academic professionals and residents. Coordinates, delegates and evaluates personnel operations in conjunction with the director. Hires and assigns staff, students and volunteers to research projects to support departmental goals. Acts as a liaison between research support staff and the Director to communicate research objectives and resolve implementation obstacles in a timely manner.
*Manages all aspects of clinical research from project proposal, Institutional (IRB) approval, study initiation, data analysis and close out. Recruits patients/participants for clinical research studies; consents patients/participants; collects patient information; acts as project liaison between study investigators/staff and patients/participants. Manages multiple projects/protocols concurrently in a dynamic environment. Ensures compliance within department, University, State and Federal related mandates and guidelines.
Identifies and coordinates industry-supported clinical research opportunities. Reviews and compiles specific procedures from medical records to determine feasibility of conducting a research study. Assists with review of contracts for sponsored research. Sets up site qualification and site initiation visits. Receives training from sponsors for conducting sponsored research; performs measurements, completes case report forms and enters data into electronic databases. Prepares contract proposals and works with legal entities to negotiate contractual provisions and secure major contracts with potential partners. Negotiates clinical study budgets with investigators or designated site personnel.
Oversees the configuration and development of the Patient Reported Outcomes system. Identifies trends in measurement collection for publication, works with legal and other entities to obtain scoring and licensing, works with vendor to implement measure within software, trains clinic staff and faculty regarding the measures offered and how to administer to patients. Schedules measures using vendor software and the electronic health records system, works with vendor to maximize automation and system efficiency while maintaining a high completion rate. Extracts data on demand for use in research and quality reporting. Ensures data integrity and monitors access to institutionally approved protocols only in compliance with federal regulations. Onboards new clinics, identifies, purchases and configures compatible hardware, performs site suitability visits, provides training to staff, technical staff and medical assistants. Manages Patient Reported Outcome Measure administration at four clinics, including sites outside of Morgantown. Provides oversight to clinic staff in the maintenance and troubleshooting of the outcomes systems.
Communicates and resolves system issues, and develops system configurations that meet the changing needs of the institution. Works regularly with EPIC systems analysts and third party software developers to maintain the vendor interface, and to communicate and resolve issues. This task is complex and requires higher order logic and the ability to synthesize a complex array of technical subjects in a short period to make decisions that affect large amounts of data, the patient experience, and clinical research outcomes.
Master's degree in related field or a Bachelor's degree with equivalent, directly related experience.
Four (4) years of experience:
Clinical Research Coordinator
Management of patient reported outcomes systems
Working in a technology related field
Clinical research coordination
Basic database management
Certified Clinical Research Professional (CCRP)
Human Subjects training certification (CITI)
The candidate will have the opportunity to achieve them after beginning the position if he/she does not have them prior to being hired.
At West Virginia University, we pride ourselves on a tireless endeavor for achievement. We are home to some of the most passionate, innovative minds in the country who push their limits for the sake of progress, constantly moving the world forward. Our students, faculty and staff make this institution one of the best out there, and we are proud to stand as one voice, one university, one WVU. Find out more about your opportunities as a Mountaineer at http://hr.wvu.edu/.
West Virginia University is proud to be an Equal Opportunity employer, and is the recipient of an NSF ADVANCE award for gender equity. The University values diversity among its faculty, staff, and students, and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.
Job Posting: Apr 28, 2021
Posting Classification: Non-Classified
Exemption Status: Exempt
Benefits Eligible: Yes
Internal Number: 227883
About West Virginia University
West Virginia University, founded in 1867, has a long and rich history as a public, land-grant institution. WVU encourages scholarship and offers high-quality academic programs while serving the state of West Virginia and the nation. WVU statewide includes campuses in Beckley, Charleston, Keyser, Martinsburg and Morgantown – which has been ranked as a #1 Small City in America. WVU is an R1 Doctoral Research University (Highest Research Activity), one of only 115 nationwide. WVU offers 212 degrees throughout the 14 colleges and schools. Areas of specialty include STEM education, healthcare in Appalachia, shale gas utilization, radio astronomy and forensics. WVU researchers have helped confirm the existence of gravitational waves and uncovered diesel vehicle emissions discrepancies. Statewide, there are over 31,000 graduate and undergraduate students along with 190,000 alumni worldwide. WVU is reinventing West Virginia’s future by strengthening education, healthcare and broad-based prosperity.