Alyssa L. Narron
Clinical Research Director, Commercial stage biotechnology
Durham, NC · (919) 555 0134 · name@example.com · linkedin.com/in/alyssalnarron
Key Qualifications
EXPERIENCE
Eighteen years in clinical development across solid tumor and hematology programs, ten of them leading teams
INDUSTRIES
Commercial stage biotechnology, contract research services, community and academic cancer centers
SPECIALTIES
Phase one through phase three oncology trials, investigational new drug submissions, risk based monitoring, inspection readiness
SYSTEMS
Medidata Rave, Veeva Vault Clinical, SAS, Tableau, Smartsheet
CREDENTIALS
Certified Clinical Research Professional, Association of Clinical Research Professionals; Registered Nurse, North Carolina Board of Nursing
EDUCATION
Master of Science in clinical research, Bachelor of Science in nursing
Executive Summary
Clinical research director with eighteen years in oncology drug development, from oncology nurse and study coordinator to leader of a forty person clinical operations group. Runs phase one through phase three programs under good clinical practice, protects Food and Drug Administration commitments, and closed nine studies with no critical inspection findings at the sponsor level.
Signature Achievements
- Completed enrollment on the pivotal colorectal study four months ahead of plan by adding twenty two community oncology sites across the Southeast.
- Wrote and defended the clinical sections of an investigational new drug submission that cleared the thirty day review with no clinical hold.
- Cut median query resolution from nineteen days to six across eleven active studies after moving the portfolio to risk based monitoring.
- Hosted two Food and Drug Administration bioresearch monitoring inspections that closed with no observations issued to the sponsor.
- Raised Black and Hispanic participation in the lead tumor program from nine percent to twenty six percent through a community outreach and site selection plan.
- Reduced outsourced monitoring spend by 1.8 million dollars a year by bringing oversight of two studies into the internal team.
Professional Experience
Clinical Research Director
Piedmont Therapeutics, Durham, NC 2019 to present
Clinical operations for a solid tumor portfolio of nine active studies, roughly 1,400 enrolled patients and 130 sites in North America
- Leads four study management teams and a vendor oversight function, with direct accountability for timelines, quality and a 46 million dollar annual study budget.
- Chairs the protocol review board that clears every synopsis before the medical monitor and the institutional review board packages are prepared.
- Sets the monitoring strategy for each study, including central data surveillance thresholds and the triggers that send a monitor back to a site.
- Presents enrollment, safety and inspection readiness status to the development committee every month and to the board twice a year.
- Registers every interventional study on the federal registry and posts results within the required window, with no late postings since 2019.
Associate Director of Clinical Operations
Catawba Clinical Research Services, Charlotte, NC 2014 to 2019
Full service contract research organization; managed a portfolio of sponsor programs in oncology and supportive care
- Ran study delivery for six sponsors at once, holding gross margin on the oncology book above the twenty eight percent target.
- Built the site feasibility process that raised first patient enrolled predictability from sixty one percent to eighty nine percent.
- Trained and mentored twenty three clinical research associates, nine of whom moved into lead monitor roles.
- Rebuilt three rescue studies inherited from another provider and brought all three back onto the sponsor timeline.
Clinical Research Manager
Cape Fear Cancer Institute, Wilmington, NC 2008 to 2014
Site based research unit running cooperative group and industry sponsored cancer trials
- Managed a coordinator team of seven and a study menu that grew from fourteen to thirty one open protocols.
- Prepared institutional review board submissions, continuing reviews and safety reports for the full study menu.
- Kept source to case report form agreement above ninety eight percent across four sponsor audits.
Licensure and Certification
Certified Clinical Research Professional, Association of Clinical Research Professionals
Registered Nurse, North Carolina Board of Nursing, license number RN0184623
Member, Society for Clinical Research Sites
Education
Master of Science in clinical research, University of North Carolina at Chapel Hill, 2012
Bachelor of Science in nursing, East Carolina University, 2005
Core Skills
Clinical operations leadership · Protocol development · Risk based monitoring · Investigational new drug submissions · Vendor and contract research organization oversight · Site feasibility and selection · Inspection readiness · Good clinical practice · Study budgeting · Patient recruitment strategy · Medidata Rave · Team development