4357 McVaney Road
Hendersonville, NC 28727
Job Objective Searching for a stable company in which to secure the position of Clinical Team Leader and put my management and interpersonal skills to work for company.
Highlights of Qualifications:
- Vast experience in clinical affairs, trial and project management
- Good knowledge of GCP
- Huge knowledge of orthopedics, biologics, devices and combination products
- Thorough knowledge of medical terminology, physiology and pathophysiology
- Solid understanding of the contribution of clinical affairs goals to company business strategies
- Strong organizational skills, strong written and verbal communication
- Ability to collaborate, multi-task and work effectively in a fast-paced matrix environment
- Ability to oversee care as it pertains to case management objectives
- Ability to supervise, mentor, lead, develop and evaluate clinical team members
Clinical Team Leader, August 2005 – Present
Piedmont Healthcare, Hendersonville, NC
- Supervised Clinical Affairs employees.
- Mentored and coached staff in the design and execution of clinical studies.
- Created and presented training curricula for department.
- Developed protocols and clinical trial materials.
- Lead Clinical Affairs developer of statistical analysis plans.
- Ensured quality and compliance of clinical program.
Clinical Team Leader, May 2000 – July 2005
Southcrest Hospital, Hendersonville, NC
- Maintained overall investigational product accountability and inventory.
- Prepared internal files and investigative sites for clinical quality and FDA audits and inspections.
- Coordinated and authored regulatory and clinical submissions.
- Identified issues and developed problem-solving strategies for assuring study timeliness are met.
- Conducted Key Opinion Leader meetings with industry experts for clinical initiatives.
- Created, maintained study budgets and timelines.
- Overseen activities of Clinical Research Associates (CRAs), including role of primary contact for contract CRAs.
Bachelor’s Degree In Medical Technology, Paul Smiths College, Paul Smiths, NY