SUMMARY

• Health research professional wif extensive management experience in clinical trials
• Project management, and epidemiology research.
• Managed multiple clinical studies
• Managed/Monitored clinical sites
• Phase me - IV drug trial experience
• Designed Case Report Forms
• Prepared FDA submissions
• Managed 3rd party vendors (CROs)
• Managed multiple projects’ budgets
• Maintained regulatory documentation
• Wrote Monitoring Plans
• Ophthalmology, Orthopedics
• Dermatology, Cardiology
• Hematology/Oncology
• Infectious Diseases Diabetes
• Endocrinology, CNS
• Blood Transfusion Products
• Rheumatoid Arthritis
• Osteoarthritis, Migraine
• Parkinson’s Disease, Medical Imaging
• Anesthesiology Monitoring
• Medical Devices, and Cervical Cancer Epidemiology

PROFESSIONAL EXPERIENCE

Confidential, Marblehead, MA

Sr. Clinical Research Monitor

Responsibilities:

• Functioned as a remote regional CRM/Sr. CRA monitoring a post FDA approved Medtronic insulin pump study wif a closed loop CGM system following glycemic control among enrolled Type 1 diabetic subjects
• Therapeutic areas: Type 1 Diabetes, Insulin pumps, Class 3 Medical Devices
• Ensured scope of work and oversight management of clinical sites

Confidential, Raleigh, NC

Sr. Clinical Research Associate

Responsibilities:

• Short term contract assignment functioning as a regional Sr. CRA transitioning monitoring responsibilities between two CROs for their sponsor’s (Amgen) clinical studies
• Directly involved in transitioning clinical sites involved in: Hematology/Oncology, Osteoporosis, Nephrology,, and Phase 2 and Phase 3 clinical drug trials
• Maintained data management oversight of active (enrolling) clinical study sites
• Employed as a regional CRA monitoring and managing clinical sites for several CRO clients.
• Directly involved wif clinical site evaluation visits, site initiation visits, interim monitoring visits, and study closeout visits
• Assisted in managing monitoring plans & clinical sites
• Trained site investigators and coordinators in study protocol procedures and study EDC systems
• Monitored & queried subject’s EDC data
• Coordinated site study supplies and their logistics wif 3rd party vendors
• Managed 3rd party vendors for equipment needs and investigative drugs
• Utilized multiple clinical trial EDC systems (Inform 4.6, Axiom Go Cubed, and Symbio’s EDC systems)
• Therapeutic Areas included: Ophthalmology/Infectious Diseases (viral conjunctivitis), Oncology (leukemia), and Dermatology (actinic keratosis, acne, psoriasis) and Phase 2 and Phase 3 clinical drug trials
• Employed as a Sr. CRA monitoring and managing clinical sites involved in a Phase II clinical trial for a biologic material used for treating chronic cartilage degeneration of the knee
• Completed Interim Monitoring visits, inventoried MRI reports, managed supply chain deliveries and updated sites on Phase III trial activities and budget allocations.

Confidential, Cambridge, MA

Associate Project Manager / Sr. Clinical Research Associate

Responsibilities:

• Employed as an Associate Project manager/Sr. CRA monitoring and managing clinical sites involved in clinical studies for medical devices. Directly involved in osteoarthritis, ophthalmology (glaucoma), and diabetes medical device trials
• Managed and approved project budgets, timelines, 3rd party vendors
• Completed Site Qualification and Initiation Visits
• Monitored Clinical Sites - Interim Visits
• Oversaw production of all project deliverables to sites by 3rd party vendors
• Conducted Investigator Qualification Screening activities (phone and onsite)
• Verified project-specific site training (investigator and coordinators) and their documentation

Confidential, Waltham, MA

Clinical Research Associate (Lead) (Decentralized Staff)

Responsibilities:

• Managed and accounted for one to three sponsor’s research protocols
• Managed and monitored the progress and related issues of clinical trials at individual clinical sites
• Directly involved wif Rheumatoid Arthritis, Ophthalmology (diabetic macular edema), Cardiology, Oncology/Hematology, and Migraine (CNS) drug trials
• Utilized web based clinical trials software (Inform 4.5 & 4.6) for subject data capture, review, and report writing
• Interfaced wif the sponsor, 3rd party/external vendors, and clinical sites
• Maintained study databases and files (CTMS)
• Managed and was accountable for one to three research protocols
• Verified project-specific training (investigator and coordinators) was completed and documented

Confidential, Norwood, MA 1

Sr. Clinical Research Associate

Responsibilities:

• Employed as an in-house Sr. CRA reviewing paper and electronic CRFs for a large pediatric anesthesiology study
• Completed data management activities related the BIS® EEG monitoring system’s clinical trials
• Reviewed field (CRA) monitoring reports for correctness
• Managed the day-to-day operations of a series of clinical research studies and their sites investigating new outcomes for prototype medical lasers produced and in development for cosmetic dermatology applications
• Served as the Lead CRA wif all study responsibilities
• Managed and approved project budgets and timelines
• Monitored clinical sites & reviewed medical reports and charts for protocol compliance
• Reviewed & prepared study protocols
• Designed study CRFs
• Designed CRF databases (Access & Excel)
• Worked wif IRBs, Research Scientists, Clinical Investigators, and Clinical sites
• Completed clinical data analysis and clinical outcomes sections of final study reports

Confidential, Waltham, MA

Responsibilities:

• Employed as a clinical study operations manager (CSOM) wifin the Phase me clinical trials group at PFIZER GRD.
• Updated Phase me trial’s registry and regulatory documents
• Proofed study protocols for data management & clinical monitoring tasks
• Conducted discrepancy testing of data management modules in Oracle Clinical and generated ad hoc study progress reports for current and future Phase me trials’ activities including dementia & CNS compounds

Confidential, Wayland, MA

Project Manager for Clinical Studies

Responsibilities:

• Clinical Project Manager who directed a series of clinical studies under GCP guidelines involved wif several medical laser systems (Class II medical device) seeking FDA approval for cosmetic dermatology applications & established relational databases (Access) for data entry, clinical monitoring activities, and adverse event reporting
• Monitored regional sites (MA area) for medical laser clinical studies under IDE and 510(k) guidelines
• Assisted in writing clinical sections for both IDE & 510(k) FDA applications for Class II medical devices
• Worked wif clinical sites treating subjects, completed direct review of clinical data, and monitored research protocol compliance and safety issues by investigators
• Developed ISR projects wif leading dermatologists sponsored by Candela.
• Managed the Biostatistics and Data Management aspects of one Phase 1, two Phase 2, and two Phase 3 clinical trials based in North America. Duties involved
• Facilitated project team cooperation by maintaining communication among five departments resulting in on time deliverables to client (Novartis)
• Developed a system to monitor project resources, budget, and timelines to assist department line managers
• Worked closely wif client (Novartis) team regarding anticipated timelines, safety issues, and SOP compliance
• Renegotiated project timelines and budget wif department supervisors and client to reflect current tasks