James Foo Email & Phone Number

Easton, Md, Us

United States

United States

- 9+ years of clinical trial monitoring experience.- ICH/GCP, HIPAA and IRB/REB compliance.- Manage multiple clinical trials at one time (Up to 30 sites with 5 trials at each site).- Contact point between study sites and project managers for all study related activities.- Timely submission of research data and regulatory documents.- Conduct Site Evaluation visit (PSSV), Site Initiation visit (SIV), Interim Monitoring visit (IMV) and Close-Out visit (COV). - On site and remote monitoring of clinical sites across US and Canada. - Conduct Drug Accountability.- Manage Trial Master File Systems.- Assist in sponsor audits. - Conduct post audit corrective actions. - Assist sponsor in SIV slides revision.- Ensure protocol-defined SAEs are reported.- Queries resolutions.- Review Protocol, SOPs, CRFs and EDCs and provide suggestions for updates.- Provide protocol and various study-related training.- Provide regular monitoring and site updates to leadership. - Support study team to prepare sites for startups and closeouts of studies.- Attend regularly scheduled All Investigators meetings, Steering Committee meetings to stay current on all trails.- Participate in Mortality and Adverse Event Adjudication sessions that standardize the adjudication of each event.- Train all incoming members of monitoring team.- Serves as mentor to new CRA.

Blue Bell, Pennsylvania

Greater New York City Area

 Support activities in clinical research on cardiovascular disease ensuring compliance to regulatory standards and IRB policies. Manage the timely submission of research data and the accuracy of submitted data for multiple clinical sites in the U.S. and Canada. Conduct and assist in sponsor audit of clinical sites including the review of medical record and regulatory documents. Participate on an innovative team that is leading the industry in conducting remote monitoring of research data. Resolved discrepancies and provided guidance to sites to achieve compliance with regulatory and protocol requirement. Identify and ensure protocol defined Adverse Events are reported. Attend Mortality and Adverse Event Adjudication sessions that standardize the definition of each event.  Provide input in the development of new MOPs and to changes in existing MOPs.

New Milford Nj

 Developed and oversaw training for individual and team skills. Assessed performance for all players and created appropriate training programs. Identified and implemented team new drills to improve team skills. Instituted team building strategies. Set and revised priorities for team; recognized and motivated individuals to full potential. Counseled players and parents on college applications.

 Evaluated, recruited, and motivated players to enhance and strengthen team. Organized and planned training drills to improve both team and individual skills. Collaborated with head coach on team budgets, travel and all issues on and off the court.

 Evaluated and recommended purchase of computer systems and software within budget. Maintained computer network and ensured proper operation of medical software. Supervised the conversion of paper records to Electronic Medical Records. Responsible for all computer training for staff (software and hardware). Performed data analysis and prepared daily, monthly, annual reports. Performed periodic evaluation of workflow and implemented policies to improve efficiency. Reviewed and verified medical records were entered correctly and within timeline.  Assisted resolution of all electronic prescription issues. Ensured HIPAA, Red Flag Rules & OSHA compliance. Managed all financial transactions including medical billing, coding, and proper insurance claims submission.

Bachelor Of Science, Computer Science And

Master Of Administration, Administrative Science

Education record