• Helped write 2 protocols and 2 protocol amendments. • Participated in the feasibility process and site selection. • Developed internal and external training materials. • Trained and supervised internal CRAs, making their site assignments and approving their travel and expense reports.• Conducted pre-study selection visits, site initiation visits, interim monitoring visits, and close-out visits.• Before our automated systems were online, I coordinated and tracked shipment of supplies to all participating sites. • Co-audited vendors and sites.Over the span of 5 months, I vetted potential vendors then negotiated and executed the contracts, statements of work, and work orders then managed all 10 vendors – CRO, electronic data capture, data management, interactive web response system, 2 central laboratories, 2 statisticians, IP/placebo manufacturers, and the IP/placebo/ancillary supply depot. I also managed, tested, coordinated the beta testing, and approved all study-related builds such as eDC, IWRS, lab portals, e-diaries, and ePROs. I addressed and resolved any and all issues that arose among and between vendors and their associated systems. As a part of vendor management, I kept expectations in check and ensured that timelines were met.

• Supervised and managed 11 staff and personnel including physicians, research coordinators, nurses, dietitians, regulatory and lab staff, patient recruiters, front office workers, and interns/volunteers. I also trained incoming directors who were going to be placed at other offices and covered other sites as needed. • Helped design and implement a model new to the company involving embedding a clinical research site in an established doctor’s office. • Produced and analyzed weekly revenue and productivity reports to improve center and staff performance.• Developed marketing campaigns and related advertisements.• Negotiated budgets and contracts with sponsors and vendors.• Collaborated with businesses and sponsors to establish mutually beneficial relationships to provide more services.• Searched for ways to expand into new areas and completed feasibility studies to obtain more studies.• Met with representatives from pharmaceutical companies for site selection and auditing visits.• Conducted staff meetings as well as set the agenda and select topics for discussion and review.• Acted as a liaison between the office and the public to increase community awareness.

I worked as the Lead CRC multiple trials. I maintain 7-10 studies as a Lead CRC at our stand alone research center, and work as a back-up CRC and or unblinded pharmacist on 10 + Studies. I also travel to other sites to help run studies and cover when coordinators are out. I worked as the acting site manager for a second site while their site manager was out on medical leave. I coordinate research subject visits, lab collections, and the scheduling of procedures outside the office. Responsible for dispensing investigational product & tracking of said product throughout the course of the study. Answer and follow-up on queries, AE’s & SAE’s. Sites quality control/in house monitor and responsible for ensuring all study documentation was ready for monitoring visits. I attend investigator meetings & other seminars & educational programs pertaining to research. I maintain my GCP certification through CITI and my IATA certification. The trials I have worked on include but are not limited to; studies for the treatment of Osteoarthritis, Diabetes, Hypertension, Hyperlipidemia, Rosacea, Pruritus, Tinea Pedis, Seborrheic Dermatitis, Herpes Simplex, Gout, Flu Vaccines, Hepatitis B vaccines, Post herpetic neuralgia, Fibromyalgia, Hormonal Birth Control, Male and Female Sexual Dysfunction, Bacterial Vaginitis, Migraine Headaches, Smoking Cessation, Nocturia, Over Active Bladder, and Urinary Incontinence.

Coordinate research subject visits, lab collections, and the scheduling of procedures outside the office. Responsible for dispensing investigational product & tracking of said product throughout the course of the study. Answer and follow-up on queries, AE’s & SAE’s. Responsible for ensuring all study documentation was ready for monitoring visits. Responsible for scheduling all research meetings & monitor visits for my studies.

At the time I took over the position of Director of Clinical Research, the department had been open for 1 year and had 3 studies, within 11 months I had increased the number of studies from 3 to 13 and tripled the revenue generated by the research department. The department has only continued to grow, averaging 10-12 new studies every year. I have 17 years of research experience including both surgical devices and clinical drug studies Phases I- IV. During my time in research I have worked in all areas of clinical research including, the management of other employees, ensuring all staff are thoroughly trained on the sites SOP’s, GCP’s and all protocols. I work closely with the pharmaceutical companies negotiating all contracts and budgets. Was responsible for all regulatory documents and maintenance of all regulatory binders including IRB submission for protocol and site approval.Was the sites Sr. CRC and un-blinded pharmacist. Helped coordinate research subject visits, lab collections, and the scheduling of procedures outside the office. Responsible for dispensing investigational product & tracking of said product throughout the course of the study. Answer and follow-up on queries, AE’s & SAE’s. Sites quality control/in house monitor and responsible for ensuring all study documentation was ready for monitoring visits. I have written protocols and informed consent forms for physician initiated clinical drug studies. Have created source and CRF forms. Responsible for scheduling all research meetings & monitor visits. Responsible for creating source documents, & all advertising materials & scheduling all advertising. Attend investigator meetings & other seminars & educational programs pertaining to research. GCP certification through CITI.

Managing classrooms of 25-32 students, instructing students in A&P, Medical Terminology, teaching front office skills, such as reception and billing and coding. Clinical laboratory skills include but are not limited to; Pt. charting, Injections, Phlebotomy, Urinalysis, Microscope, and ECGs. I prepared lectures for each body system, creating projects and arranging fieldtrips to give students a better understanding of the material. I worked with student council members on fundraising and community involvement. I substitute taught for classes when instructors were out. I was responsible for training new instructors. I helped in the business office when needed and was the contact/information liaison for students wanting to certify through NCCT.