Clinical Trials Manager - Department of Orthopaedics 10139
The West Virginia University Department of Orthopaedics is seeking applications for a Clinical Trials Manager. This position is responsible for activities required to conduct clinical research studies.
In order to be successful in this position, the ideal candidate will:
Manages all aspects of clinical research from project proposal, Institutional (IRB) preparation and approval, study initiation, data analysis and close out.
Monitors regulatory compliance with all study personnel.
Prepares IRB submissions, amendments, adverse events, deviations, continuing reviews and maintains IRB documentation for each study.
Completes data collection and recording for study participants
Recruits patients/participants for clinical research studies potentially at off-site clinics
Develops forms, databases and writes standard operating procedures for data collection of non-sponsored research projects.
Coordinates industry-supported, clinical research opportunities.
Reviews and assists with budget preparation.
Instructs patients, families and hospital personnel regarding research requirements
Contributes to application process for research grants/contracts to support departmental studies.
Potential travel to industry sponsored research meetings.
Master's Degree in a health related field or an equivalent combination of directly related education and/or experience.
Licensed Registered Nurse preferred
Certified Clinical Research Professional preferred
Three (3) Years of experience:
In clinical research. Knowledge of research methods and design
Writing Institutional Review Board protocols
Electronic Database entry
Well organized, detail-oriented and able to persistently follow up with patients, physicians, investigators and sponsors when needed.
Able to plan and schedule multiple research activities.
Protect participant confidentiality and unit information. Maintain composure when handling sensitive issues.
Should be technologically facile with word processing, spreadsheets and database computer skills.
Able to prepare and report results of research activities and adhere to firm deadlines.
Frequent interaction with all members of the research team; ability to work as a team member as well as independently.
Advanced oral and written communication skills
Ensure compliance of all individuals associated with clinical research through training, guidance and example.
About WVU 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 an Equal Opportunity/Affirmative Action Employer and 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 individuals, including minorities, females, individuals with disabilities and veterans.
Job Posting: Nov 26, 2018
Posting Classification: Non-Classified
Exemption Status: Exempt
Benefits Eligible: Yes
Internal Number: 154521
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.