Kim Mintz Email & Phone Number

Wilmington, North Carolina Area

Wilmington, Nc

Independently performed and managed remote clinical monitoring tasks and remote visits for designated projects in accordance with relevant SOPs, study specific guidelines and regulations. Project managed clinical monitoring activities remotely, including issue resolution, patient enrollment management, and responding to site questions regarding protocols. Assisted in contract amendments, drug supply management and ensuring timely data entry at the site level. Worked within the SOP’s to recruit, select, and activate new sites. Initiated and processed site payments and set up payment funds. Worked as a lead CMA on the study team to mentor new staff, lead team trainings, and develop tools/templates.

Wilmington, North Carolina Area

Performed all aspects associated with quality compliance/clinical monitoring. Coordinated with Clinical Manager to fulfill requests for assistance, prioritize needs, and delegation of duties. Assisted in establishing clinical teams in order to accomplish specific tasks to meet specific goals. Conducted Performance Assessment Visits as a Qualified Accompanier. Performed study-specific training with project team. Developed study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data. Assisted Quality Risk Management with specific assigned tasks (slide presentations, assigned database area set-up and access for GQ&C personnel to shared database system, etc.). Reviewed metrics/reports to evaluate Procedural Document status and identify process improvement opportunities. Provided back up management support when assigned manager is out of the office Worked with multiple clinical teams, supervised multiple functions. Reviewed trip reports.

Wilmington, North Carolina Area

Performed initiation, interim monitoring and close-out visits. Participated in three clean data transfers, assisted in resolution of CRF discrepancies, performed database quality assurance auditing, verified completeness of critical documents, reviewed project-related materials to develop a basic understanding of study protocol and therapeutic areas and evaluated and monitored sites according to applicable Standard Operating Procedures and FDA guidelines. Reviewed reports submitted by the CRAs. Reviewed and tracked regulatory documents, performed file audits periodically, independently managed assigned sites, consistently prepared high quality reports of site management and monitoring activities, and preformed 100% source document verification with CRFs. Mentored newly hired CRAs to the team to include accompanying and signing off for site initiation visits and took the assistant lead role in creating presentations for specific types of visits for the launch meeting.

Associate'S Degree, Respiratory Therapy

Certification In Respiratory Therapy