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• Responsible for strategic planning, development, implementation and administration of a multicenter NIH grant funded research study in accordance with scope of work, MOP, and GCP guidelines. • Managed multifarious teams, including laboratory, medical staff, research coordinators, assistants and two external sites in study execution• Collaborated closely with Lead CRA to ensure all monitoring activities are conducted according to study requirements• Prioritized patient safety by reviewing current IRB approved subject informed consent forms, site consenting procedures, and prompt reporting of adverse events/SAEs. Performed ongoing source document verification of subject charts and CRF data remotely and on-site through EDC and e-Diary systems• Responsible for developing the non-scientific portions of a standard research protocol. Collaborated with the investigator to draft non-scientific/clinical aspects including project scope. Reviewed the entire protocol document for consistency, clarity, formatting and correct grammar. Assisted with Informed Consent Form development. Drafted and developed study and site SOPs• Scheduled and performed pre-qualification, initiation, interim and recruitment for participant visits of Phase II-III clinical research studies. Monitored and analyzed study results and protocol outcomes. Participated in process improvement and quality-related initiatives associated with study execution and deliverables; participated in establishing of best-in-class processes and standards for study conduct• Managed project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress final reports• Drafted budget proposals, tracked revenue and involved in invoice reconciliation • Led weekly staff meetings and trained staff on study specific protocol

• Completed administrative duties in accordance with protocol, sponsor, CRO and site requirements and in collaboration with Principal Investigator. Attended investigator meetings, completed required study initiation duties and ongoing management tasks in accordance with protocol and sponsor requirements• Served as primary contact between CRO and site investigator; coordinated all correspondence; ensured timely transmission of clinical data with the study site and technical reporting, as requested• Collaborated closely with CRAs to ensure all monitoring activities are conducted according to study requirements• Participated in internal monitoring and site audits • Ensured all study deliverables were completed per CRO and study timelines• Managed operations of site, including 12 clinical research coordinators in executing 28 distinct research studies. Participated in hiring, interviewing and retaining qualified professional staff. Trained new clinical research coordinators on clinic procedures and operations• Conducted and led monthly staff educational meetings addressing FDA and GCP implementation across site• Initiated action regarding new policies and procedures. Monitored quality of performance to assure optimal service delivery and accurate statistical data• Represented the clinical research site at conferences and investigational meetings, such as Society of Clinical Research Associates (SOCRA) and Model Agreements and Guidelines International (MAGI)• Utilized MedidataRave and Oracle

• Conducted pre-qualification, initiation, interim, recruitment and close-out of Phase II-IV clinical research studies, in accordance with scope of work, SOP, and GCP guidelines• Submitted detailed and accurate reports and maintained correct documentation regarding visit findings, protocol deviations and implementation of corrective action plans to ensure future compliance with applicable regulations (sponsor, CRO, FDA, ICH/GCP, IRB)• Ensured proper escalation of quality issues in accordance to escalation pathway. Prioritized patient safety by reviewing current IRB approved subject informed consent forms, site consenting procedures, and prompt reporting of adverse events/SAEs• Performed ongoing source documentation, verification of subject charts and CRF data remotely and on-site through EDC systems. Reviewed data for accuracy and completeness by issuing queries to verify consistency, integrity, patient safety and regulatory compliance. Adhered to site quality control requirements, SOP’s and principles of GCP in the conduct of study and participant related activities