How You’ll Help Transform Healthcare:
Responsible for management and oversight of Carilion Clinic Clinical Trials. Communicates, facilitates, prioritizes and problem-solves with management, support staff, faculty, consultants, physicians and others to ensure high-quality, efficient and cost-effective clinical trial management. Responsibilities may include trials supported by federal and foundation grants, as well as industry contracts, including investigator-initiated trials, and non-sponsored projects. Assumes additional responsibilities as delegated by the Senior Director of Research.
Performs specific job responsibilities:
• Manages staff of the clinical trials including the clinical research coordinators and nurses, and the staff of the Office of Sponsored Projects in conjunction with the Director of Grants Management including the Research Assessment and IP Manager. Completes evaluations, facilitates professional growth and development and assures the effective measurement of outcomes.
• Participates in a matrix-management environment to oversee other clinical research and research finance staff within the organization. Actively participates in recruitment, retention and development of quality employees. Coordinates work flow and assignments to ensure the most efficient and effective use of personnel and resources.
• Manages the pre-award process for new clinical trials, including facilitating the contract review and negotiation, as well as budget preparation.
• Develops the Billing Matrix for clinical services and participates in developing the research ordersets used in the electronic medical record.
• Participates in all feasibility meetings for clinical trials. Proactively identifies potential problems and uses expertise to trouble shoot as needed.
• Works with finance in the Post Approval Monitoring (PAM) process. Ensures that all clinical trials comply with all requirements of the approved study protocol, the approval Institutional Review Board (IRB), Carilion Clinic, and, if applicable, Food and Drug Administration (FDA) or other regulatory agency requirements.
• Education and Assessment.
• Proactively seeks opportunities for procedural improvement and staff education, while auditing and monitoring research activity. Provides both planned and as-needed education regarding protocol and/or compliance adherence.
• Develops and provides proactive education through formal instruction and informal workshops. Delivers formal presentations related to clinical research coordination and billing compliance, including use of appropriate software programs and databases.
• Works cooperatively with OSP, clinical research staff and investigators to address their concerns and communicate findings leading to improved performance and compliance, identify potential problems through audit processes and develop appropriate solutions.
• Partners with Senior Director and Director of Grants Management in the development of research policies, procedures and educational materials related to research compliance, as well as OSP internal processes and process improvements.
What We Require:
Education: Master’s degree in related field from accredited college or university required.
Experience: 5-7 years prior experience in clinical or healthcare environment with demonstrated clinical trials management required. Prior experience with an electronic medical record preferred.
Licensure, certification, and/or registration: Certification as a Clinical Research Professional (CCRP) or Clinical Research Coordinator (CCRC) preferred upon hire. Will be required to obtain a research certification within one (1) year of hire if not previously obtained.
Other Minimum Qualifications: A thorough understanding of federal regulations that govern human subject research. Proven ability to clearly communicate with staff, physicians and management. Ability to develop and present information in a presentation setting. Strong computer skills in word processing and spreadsheet functions. Effective business writing skills; ability to resolve problems; high integrity, innovation, customer-focused philosophy; willing/ability to work as a team player; desire to learn and receive continuous training/education. Prior experience and an understanding of the general working of research administration policies and procedures extremely helpful. Experience in preparing contracts, reviewing contracts and making suggestions for changes which include, but are not limited to, confidential agreements and clinical trial agreements. Demonstrates proficient leadership skills.
About Carilion
This is Carilion Clinic ...
An organization where innovation happens, collaboration is expected and ideas are valued. A not-for-profit, mission-driven health system built on progress and partnerships. A courageous team that is always learning, never discouraged and forever curious.
Headquartered in Roanoke, Va., you will find a robust system of award winning hospitals, Level 1 and 3 trauma centers, Level 3 NICU, Institute of Orthopedics and Neurosciences, multi-specialty physician practices, and The Virginia Tech Carilion School of Medicine and Research Institute.
Carilion is where you can make your own path, make new discoveries and, most importantly, make a difference. Here, in a place where the air is clean, people are kind and life is good. Make your tomorrow with us.
Requisition Number: 143653
Employment Status: Full time
Location: CRMH - Carilion Roanoke Memorial Hospital
Shift: Day
Shift Details: Monday through Friday; 8:00 a.m. to 5:00 p.m.
Recruiter: RHONDA E JOHNSON
Recruiter Phone:
Recruiter Email: REJohnson@carilionclinic.org
For more information, contact the HR Service Center at 1-800-599-2537.
Equal Opportunity Employer
Minorities/Females/Protected Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity
Carilion Clinic is a drug-free workplace.