Service-oriented Site Manager with proven success, excelling in team building with a focus on integrity and quality assurance. Achieved enhancement of communications between site members and clinical staff. Skilled in operations management and problem-solving, adept at developing patient recruitment strategies to meet enrollment targets across multiple clinical trials.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Site Manager
Avacare
01.2024 - Current
Conducted regular site meetings with team members, fostering open communication channels for efficient problem-solving and progress updates.
Interviewed, hired, and trained new workers. Responsible also for the ongoing training of staff/providers, process development, point of contact for the Directors of
Operations and cross-functional teams.
Played a key role in assisting in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials.
Worked closely with Business Development and Feasibility on study placement.
Accountable for enrollment success at sites across all studies.
Maintained significant depth of knowledge and experience in coordinating across multiple therapeutic areas.
Conducted 1:1 meetings and annual reviews with site staff.
Performed quality control checks on source and regulatory documentation. Regular site inspections also performed enforcing strict adherence to safety protocols.
Worked closely with Quality Assurance Department to ensure quality at site; created processes and CAPAs to improve trends
Complied with IQVIA, CCT, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines
Site Manager
AES/Synexus Research, Inc
09.2020 - 05.2023
Oversaw the conduct of assigned site; responsible for the training of staff/providers, process development, point of contact for the Directors of Operations and cross-functional teams.
Works closely with Business Development and Feasibility on study placement.
Worked to understand revenue expectations.
Developed and implemented patient recruitment strategies.
Maintained significant depth of knowledge and experience in coordinating across multiple therapeutic areas.
Possessed the ability to coordinate as primary CRC on at least 6 studies of medium to high complexity, as well as back-up CRC on other studies when needed.
Conducted 1:1 meetings and annual reviews with site staff
Managed inventory and administered test articles/investigative product to participants.
Site Director
Jordan Valley Dermatology Center
01.2015 - 03.2020
Managed a team of professionals, ensuring high-quality performance with a focus on integrity and adherence to company standards.
Maintained compliance with regulatory requirements while continuously seeking opportunities for process improvement based on best practices.
Provided leadership and guidance to staff through ongoing training initiatives, boosting employee morale.
Developed strategic plans for site growth, resulting in increased revenue and profitability.
Supported the collection and review of required essential study documents and reports.
Ordered supportive study supplies (e.g., contracts, IXRS, lab kits,nonclinical supply materials, imaging, and laboratory handling manuals, etc.).
Adhered to an IRB approved protocol.
Facilitated pre-study, site qualification, study initiation, monitoring visits, and study close out activities
Complied with Dermatology Associates and Sponsor policies, standard operating procedures (SOPs) and guidelines
Skills
Team leadership
Site inspection and management
Problem-solving
Quality assurance
Site coordination
Multitasking and organization
Safety procedures
Operations management
Resource allocation
Staff evaluation
Schedule management
Work Planning and Prioritization
Decision-making
Therapeutic/Clinical Trial Experience
Dermatology Operations
Cardiovascular Operations
Endocrinology Operations
Hepatology Operations
Infectious Disease Operations
Respiratory Operations
Certification
Shipping and Transport of Regulated Biological Materials [CITI Program]
Biosafety/Biosecurity [CITI Program}
Biomedical Research [CITI Program]
Conflicts of Interest [CITI Program]
GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) [CITI Program]
OSHA Bloodborne Pathogens [CITI Programs]
Personal Protective Equipment [CITII Program]
Information Privacy Security (IPS) [CITI Programs]