Assistant Director of the Clinical Trials COE - Clinical and Translational Science Institute
The WV Clinical and Translational Science Institute (CTSI) at West Virginia University is seeking applications for an Assistant Director ofthe Clinical Trials Center of Excellence (COE). This positionis responsible for programmatic direction and oversight of the Researching COVID to Enhance Recovery (RECOVER) study. In close collaboration with the COE Director of Operations and the Principal Investigator, this individual will assure the appropriate clinical trial conduct for the RECOVER IDeA States COnsortium for Clinical REsearch (ISCORE) Network. In addition, this individual will support the Co-Directors of the Clinical Trial Center of Excellence (COE) with operations of the COE and provide support for development, coordination, and implementation of research and administrative strategies essential to the successful operational direction of the Clinical Research Resources and Facilities Core of the WVCTSI.
In order to be successful in this position, the ideal candidate will:
- Oversee the RECOVER IDeA States COnsortium for Clinical REsearch (ISCORE) Network with study start-up activities, participant recruitment and study procedures.
- Developcommunication strategies for the ISCORE network to ensure each site is preforming at a high level.
- Lead ISCORE internal and external meetings to ensure the success of the Network.
- Developstandard operating procedures, processes, and templates as needed for the ISCORE Network.
- Responsible for tracking and reporting the ISCORE Network metrics and escalate to management any challenges.
- Workin collaborationwith WV CTSI financeteam and the ISCORE sites to provide oversight for study budgets.
- Supportthe development of infrastructure, processes and programs to facilitate excellence in clinical trial conduct across the WVU research community and WVCTSI partner sites.
- In close collaboration with the COE Co-Directors, supportthe development of institutional standard operating procedures and/or work instructions and trainings on a number of topics relevant to the conduct of clinical trial conduct and regulatory, research coordinator and principal investigator training.
- In collaboration with the Co-Directors of the COE, support the timely review of COE clinical trial registrations, facilitate the risk assessment committee (RAC) and appealcommittee preparation. May attendRAC and Appeals Committee meetings in a supportive role, as needed.
- Participate as a member of the Senior Clinical Research Executive Committee, as needed.
- Collaborateregularly with WVCTSI administrative directors and managers to develop and execute cohesive strategies to advise clinical and translational science, while fostering a positive work environment.
- Master's degree in Health Sciences or related field OR an equivalent combination of education and directly related experience.
- A minimum of ten (10)years of clinical trials research experience, including at least six (6)years of supervisory or program management experience.
- Excellent time and project management skills.
- Excellent customer service skills and the ability to communicate effectively with patients and families; pharmaceutical company personnel; regulatory and monitoring agency personnel; and internal staff members. Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
- Knowledge of group behavior and dynamics, societal trends and influences, human migrations, ethnicity, cultures and their history and origins.
- Analytical demands - Involves oversight of a wide range of duties associated with the development, implementation and management of clinical research protocols.
- Ability to prioritize tasks.
- Must possess and apply knowledge of many different and unrelated processes and methods related to such areas as patient care, counseling and education; data collection, validation, entry, analysis, and reporting; treatment design, administration and modification; human subjects protection and related issues.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Ability to write routine reports and correspondence.
- Ability to speak effectively before groups of customers or employees of the organization.
- Ability to apply concepts of basic algebra and geometry.
- Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume.
- Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
- Ability to deal with problems involving several concrete variables in standardized situations.
- Letter of Interest
- Certification by Association of Clinical Research Professionals (ACRP)
- Medical Monitoring -- This position may or may not require Medical Monitoring, including periodic health monitoring and/or training.
- Due to the nature of this position the successful candidate may be required to verify that they are fully vaccinated for COVID-19.
At West Virginia University, we leverage our talents and resources to create a better future for our state and the world. As West Virginia's land-grant university, WVU has three campuses that touch each corner of the state. The WVU System includes 518 buildings on 15,880 acres, Extension Service offices in all 55 counties, ten experimental farms and four forests.
From the groundbreaking R1 research of our flagship campus in Morgantown to the career-oriented programs of WVU Potomac State in Keyser to the technology-intensive programs at WVU Tech in Beckley - the contributions of WVU employees directly impact the 1.8 million people of West Virginia every day, no matter their role or position.
Service, curiosity, respect, accountability, and appreciation are the core values that unite Mountaineers, inspiring one another to work tirelessly and support others as they seek to reach new heights. After all, when you're a Mountaineer, impossible is just another mountain to climb.
To learn more about West Virginia University, visit go.wvu.edu. View current career opportunities at careers.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: Oct 11, 2021
Posting Classification: Non-Classified
Exemption Status: Exempt
Benefits Eligible: Yes