Management of multiple sites for a large, multicenter Phase III Dermatology studyPreparation, collection and tracking of study-level documentsReview, updating and testing of clinical systemsProduction of study-level reports on clinical status, trends and metricsFacilitation of study communication across Allergan departments and outside clients

LIFECELL, Bridgewater, New JerseyClinical Research Associate II (March 2013 to present)• Assisted in the development, review and implementation of a template Clinical Monitoring Plan• Function as a monitor for four sites participating in a rotator cuff surgery study• Assisted in the identification of fields and spearheaded the creation of an associated monitoring spreadsheet for primary monitoring use for a retrospective Breast Plastic Surgery study• Created source worksheets for site use in a prospective, single arm study to evaluate surgical site drainage management in post-mastectomy breast reconstruction patients

• • Function as Clinical Study Manager and provide direction for a multidisciplinary team in order to conduct activities for a phase IIb study• Communication with vendors in preparation of study start-up activities• Assist in the creation of study documents, including protocols, clinical monitoring plans, and study reference manuals• Responsible for the approval of time sheets and expense reports for Clinical Research Associates who contract with the Sponsor• Function as a back-up and Lead CRA to the Clinical Study Manager for a Phase III Spermatogenesis study• Assist in the process of training new hires, including review of current policies, standard operating procedures, and work instructions• Instruct new employees as to proper monitoring techniques as well as introduce then to the current electronic systems in use by the department• Aid in the interview process for potential candidates for hire• Conduct monitoring activities, from site selection and initiation to routine monitoring and close-outs

• • Conducted monitoring activities for multiple investigational sites in sponsor-initiated studies• Continuously maintained an efficient system of communication among internal and external partners• Responsible for the review of Monitoring Visit Reports of other Clinical Research Associates• Performed multiple internet searches in order to assist with the selection of investigators for sponsor-initiated clinical studies• Performed Quality Control reviews of multiple Sponsor protocols in order to prepare for future audits• Participated in the analysis of test scripts which were generated in advance of the implementation of an electronic data capture system currently in use ion Sponsor studies

• Responsible for the verification of data entry for various studies• Performed overall review of individual patient listings and comprehensive study data listings• Reviewed protocols for compliance• Performed tracking of query status and CRF receipt and entry• Responsible for the generation, coordination and completion of status reports• Assisted in providing additions / changes to the Lab Normals database• Preparation of data for Quality Assurance and follow-up• Maintained list of data conventions with project guidelines• Preparation of data sets for site visits• Preparation of data queries to sites and, if necessary, composition of queries in order to respond to issues needing follow-up• Involved in the ongoing maintenance and day-to-day undertakings of thirteen Phase I and Phase II protocols• Responsible for contacting and recruiting clinical sites for expanded enrollment of a Phase III Metastatic Melanoma trial; performance of clinical reviews of various protocols• Preparation of status reports and other clinical reports documenting enrollment and query resolution issues for a Phase III Metastatic Melanoma trial• Wrote up initial and prepared final drafts of minutes, teleconferences, and internal meetings