David Genc Email & Phone Number

• Implementation and monitoring of (phase 1 through 3 oncology) clinical trials.• Responsible for multiple protocols• Ensure sponsor and investigator obligations are being met as compliance with applicable local and regulatory requirements.• Visit sites to instruct site personnel on proper study conduct.• Review data and ensure accuracy of data collected and termination of studies• Complete billable work in accordance with company policy, procedures, and Standard Operating Procedures (SOPs).• Communication of common site trends to Project Manager and other team members.• Perform investigative site file reconciliation, source document verification, retrieve CRFs, perform query resolution, and ensure proper SAE reporting.

• Implementation and monitoring of (phase 2 and 3 oncology) clinical trials.• Ensure sponsor and investigator obligations are being met as compliance with applicable local and regulatory requirements.• Visit sites to instruct site personnel on proper study conduct.• Review data and ensure accuracy of data collected and termination of studies• Complete billable work in accordance with company policy, procedures, and Standard Operating Procedures (SOPs).• Communication of common site trends to Project Manager and other team members.• Perform investigative site file reconciliation, source document verification, retrieve CRFs, perform query resolution, and ensure proper SAE reporting.

Wilmington, Nc, Us

• Performs and coordinates assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and medical devices.• Conducts site visits to determine protocol and regulatory compliance, and prepares required documentation. • Develops collaborative relationships with investigative sites and client company personnel.• Therapeutic areas: insomnia, musculoskeletal, genito-urinary.

Raleigh, North Carolina, Us

11/03-4/04Safety Specialist• Compile necessary medical information to complete required client and Regulatory reports and drafts summary narratives of patient SAE chronologies. • Process all adverse event reports according to project procedures and regulatory reporting obligations. • Implement and maintain a computerized case file system for receiving and tracking adverse event information. • Monitor all safety reports and alert the responsible Medical Officer of any discovered safety issues. • Generate reports to the client, FDA, HPB, and other regulatory authorities in a timely manner.• Provide periodic SAE and AE reports to Project Managers, Medical Officers, Sponsors, Regulatory Affairs, IRBs and others as requested. • Manage and ensure quality and accuracy of adverse event record files.5/02 – 4/04 Clinical Research Associate I• Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while developing an understanding on the drug development process, Clinical Practices, and relevant regulations. • Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines of Standard Operating Procedures (SOPs).• Therapeutic areas: post-op pain (CNS), oncology (chemotherapy/anti-nausea)03/02 – 5/02 Clinical Monitoring Specialist• Assisted Clinical Monitoring Team in the conduct of all in-house and on-site aspects of projects within Clinical Services SBU. Prepared necessary study materials and documents (regulatory and otherwise) for study initiation through closeout. Performed basic on-site activities on behalf of clinical monitoring• Therapeutic areas: cardiac (MI), pain management

Us

• Monitored populations of fishes in the waters of Lake Michigan and Northern Illinois.• Performed research on the water and in the lab. • Worked with four other Biologists. Presented research to other Biologists and the general public.• Monitored lakes, ponds, wetlands, and terrestrial environments for public, private, and government organizations. • Rehabilitated environments due to pollution, degradation, or other influential factors.