My experience in clinical research includes varied involvement in the clinical research industry as an FDA auditor for dozens of complex HIV studies, followed by a 2 year period as a PM for Oncology studies. Involvement as PM included Head and Neck, Breast and Lung Cancer study management for this period including site management over participating sites complements my expertise.

I transitioned to an independent CRA, participating in almost all therapeutic areas with primary emphasis in Oncology (Primary fluid tumors but also solid tumors), Cardiology (Both compound and device) and Neurology (Parkinson's, MS, Alzheimer's Dx studies). Involvement with a modest number of orphan drug studies in Oncology, Pediatrics and Neurology is also of note.

Solid experience reflects primarily Phase I and II studies with extensive understanding of RECIST 1.1 for solid tumors and staging expectations for fluid tumors.

Performing every onsite visit to include numerous prestudy visits, initiations, closeouts and routine monitoring visits where I am usually primary but have also acted as co-monitor when necessary adds to the resume.

A complete commitment to every project for which I have been selected has always been my working principle including timely and reliable communication with my manager or lead. Preparing a comprehensive agenda for all visits in order to maximize time while on site and submitting trip reports with follow up letters, on or before deadlines, is strictly adhered to.

Being solid and dependable with every project and endeavor, coupled with commitment and attention to detail, mesh well with a respect for the chain of authority and issue resolution practices.

Monitoring Experience

Monitor: Phases I - IV: Compound

Study Lead Management & Mentoring
Comprehensive Site Management: Trouble Shoot
Source Document Checklist Development & Expectations
Study Site Visit Management: PreStudy, Initiation, IMV, COV, QA
Swat Team Data Re-monitoring
Monitoring Tool Creation per study.
Reg Document Prep for FDA/Sponsor Audit
Patient-Material Development
QA Site Review: EDC/CRF, Regulatory & Pharmacy.
Study Tool Development & Monitoring Metric Checklist
Therapeutic & Regulatory Training: Oncology/Cardio/Neuro & Device.
Site Load/Average: 8 - 10
Average # Protocols: 4 (Greatest #: 17)

Auditing Experience:

FDA Field Auditor: Infectious Diseases/Oncology / Cardiology/Pediatrics
Annual Report Writing to include Non- Expedited SAE compliance
GCP Audits: CFR Regulatory Compliance for drug and device
For Cause and Surveillance: Form FDA 483 record submission.
CRO Transferred Regulation to Sponsor compliance
STRONG Regulatory Background in CFR & ICH-GCP Guidelines.

Project Management:

Project Management of Phase I & II Compound Studies in Oncology
Device Studies: Monitoring and Lead
Monitoring Plan Development & SOP Training and Review reversion
CIOMS creation/responsibility, submission with distribution & Pharmacovigilance Oversight
Business Development/Contract Bid Proposals for sponsor & negotiation of SOW
Study Start-up for Sponsor involving Vendor Coordination With SOW/CO: Phase 1 and II
Regulatory Compliance Training: FDA CFR & ICH-GCP Guidelines
Regulatory Policy Development
SAE report submission for CIOM reports.
Data Management and Edit Check Oversight
Monitor Training and Metric Oversight
Study Budget Balance & Payments based on CTA
CRA Report Review and CRA mentoring/training

Study Development & Writing:

Protocol Design/Development
CRF/EDC Design/Development/QA
IND/NDA Report Writing & Submissions
Clinical and Technical Medical Writing
Vendor Acquisition & communication/budget
Blood Volume Calculator Quantification
Monitoring Plan conception
Monitoring Tool development by study