Clinical Research Coordinator

ADAM D. SHEPHERD

Address: **** **** ******** *****, ***. 202, The Colony, Texas 75056

Mobile: 940-***-****

Email: **************@*****.***

PROFESSIONAL SUMMARY

Highly reliable and motivated clinical research professional with substantial experience in coordinating clinical trials, regulatory affairs and site development. Effective independent worker motivated by team goals and successes. Creative problem-solver and critical thinker who delivers innovative solutions that are consistent with GCP Guidelines and FDA Regulations. Readiness AREAS OF EXPERTISE

• SOPs: Development and Implementation • Essential Document Management

• FDA Guidelines and Regulations • CAPA Plans: Writing and Implementation

• Good Clinical Practice (GCP) Guidelines • EDC/IVRS Systems and Query Resolution

• Audit Preparation: Readiness and Compliance • Research Sites: Structuring and Development

• IRB Submissions and Reporting Guidelines • Microsoft Office Proficiency PROFESSIONAL EXPERIENCE

SHEPHERD HEALTHCARE JAN 2010 – MAY 2016

FAMILY MEDICAL PRACTICE LEWISVILLE, TEXAS

DIRECTOR OF CLINICAL RESEARCH* FEB 2015 – MAY 2016

• Primary subordinate to the Principal Investigator; handled all site-level administrative tasks associated with conducting clinical trials; Facilitated all communications between site and study teams from start-up to close-out

• Managed and trained all site coordinators and regulatory coordinators on site SOPs and the clinical trial process as applicable; ensured training and the corresponding documentation for all individuals listed on the DOA logs as appropriate

• Developed and implemented site level forms and procedures that comply and adhere to study specific protocol, FDA Regulations and GCP guidelines (including Standard Operating Procedures, CAPA Plans, Study Specific Source Documents, Quality Control Measures, monitoring visit follow-up items, etc.)

• Negotiated clinical trial budgets with Sponsors and CROs; reviewed and amended Clinical Trial Agreements, ensuring applicable language was used

REGULATORY COORDINATOR* MAR 2013 – JULY 2015

• Created, standardized, and maintained site’s Regulatory Site File, (including systematic organization of required and ongoing licensure/training/certification for site personnel, certifications and scheduled calibration of facility’s medical instruments, templates and guides for site-level forms, etc.)

• Prepared and arranged all key regulatory materials, investigative product logs, and other study-specific documents for monitor/sponsor/auditor visits; regularly conducted internal audits of all site-level documentation

• Prepared and reviewed submissions to Institutional Review Board, including: initial IRB approval for study-specific protocol, site specific recruitment materials, unanticipated events (SAEs, Device Malfunctions, Mis-Randomizations, Protocol Deviations, etc.) ongoing study status reports, changes to site personnel, etc.

CLINICAL RESEARCH COORDINATOR* DEC 2011 – MAR 2013

• Coordinated and facilitated subject’s scheduled visits including: presentation/explanation /collection of informed consent forms, recording of vital signs, collection of bloodwork and spirometry results, collection and timely reporting of AEs/SAEs, completion of study-specific questionnaires, entering all pertinent data into the study-specific electronic data capture system, etc.

• Facilitated and documented ongoing communications between trial subjects and the site; ensured subject safety issues/concerns were reviewed by the PI.

• Organized and maintained subject study binders, ensuring all data collected from the subjects was up-to- date and readily available for CRA/Auditor review

OFFICE ADMINISTRATION &PATIENT LIAISON JAN 2010 – DEC 2011

• Tasked with various administrative duties that included, scheduling appointments, coordinating and facilitating Medical Providers’ visit flow, maintaining medical records, collecting patient payments, verifying insurance, and documenting all tasks in electronic medical records system

• Acted on behalf of the medical providers to build and maintain relations with over a dozen senior care centers; worked with clinical research personnel to identify and recruit potential patients for the active clinical research trials, planned and executed multiple receptions and educational talks for patients and their families

• Designed and executed marketing strategies to target specific patient populations including: coordinating presentations at local health fairs, sponsoring local nonprofit organizations (sports camps for kids, restoration of homes for seniors, women shelters, food pantries, etc.), creating and strategically placing ads in local newspapers, etc.

*Responsibilities delegated by, and under the oversight of, the Principal Investigator CERTIFICATIONS

Good Clinical Practice Certification 2015

IATA and DOT Training Certificate – Eduwhere 2015

Spirometry Fundamentals – Washington State University 2014 Coordinating a Clinical Trial: In-class training and certification – Medical Research Mgmt. 2013 EDUCATION

UNIVERSITY OF NORTH TEXAS (ANTICIPATED) 2017

• Bachelor of Arts, Political Science DENTON, TEXAS

• Current GPA: 3.95 – Deans List

• Completed Associate’s Degree for Transfer at North Central Texas Community College HUMANITARIAN & FUNDRAISING ACTIVITIES

BNAI ZION FOUNDATION DALLAS, TEXAS 2012 – PRESENT

• Serving regularly as assistant coordinator for fundraising events to support Bnai Zion Medical Center and Children’s Village in Haifa, Israel – a leading urban hospital that serves the entire community regardless of ethnicity, religion, or economic background.

• Received honoree award for showing exemplary leadership in the Dallas Community IRIS INTERNATIONAL MINISTRIES MOZAMBIQUE, AFRICA 5/2010 – 08/2010

• Lived for 3 months in Africa and participated in humanitarian outreach projects with the rural and poor populations of Mozambique – included meal service to thousands in the local community, orphanage assistance, medical care, and cultural exchange in music and art. EAGLE’S WINGS MINISTRIES BUFFALO, NEW YORK 2008 – 2009

• Served as Executive Assistant to the Founder and Director of an international non-profit organization involved in conducting educational and inspirational conferences around the world, with a primary focus on seeing peaceful relations within the Middle East

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