******* River Road

Fairfield, Ohio *****

513-***-****

Email: ac3ev3@r.postjobfree.com

Home: 513-***-****

Cell: 513-***-****

Anthony L. Gardner, CIP

Summary of qualifications

Exceptional communication skills. Adept at building relationships with a diverse range of personality types.

Integral member of the development of Enterprise database used at Schulman Associates IRB and ePAS database used at University of Cincinnati.

Developed a mentoring program for a large research based company.

Skilled in preparing and conducting classroom presentations.

Achieved my Certified IRB Professional designation in the fall of 2009.

Work experience

November, 2013-Present University of Cincinnati IRB

Cincinnati, Ohio

Project Management/Business Analyst

Responsible for project coordination and planning activities for a diverse set of projects. Also responsible for ensuring that the final deliverable of a software development project meets all of the intended needs of the business.

Requirements gathering for a paper based to web=based system for Radiation Safety

Development of a submission process within our existing electronic database for processing of a central IRB grant received by the university.

Transition from a paper based conflict of interest submission to utilization of the institutions existing electronic database.

November, 2007-Present University of Cincinnati IRB

Cincinnati, Ohio

IRB Office Manager /Program Director/Alternate Board Member

Assist in the management of the entire Institutional Review Board (IRB) operation and in the management of a comprehensive human research protection program with an emphasis on compliance and ethical oversight. Oversee the entire IRB process of medical and social and behavioral research protocols. Assess, develop and implement appropriate policies and procedures. Provide guidance to investigators and research staff on federal and institutional regulations and ethical concerns.

October-2005– November, 2007 Schulman Associates IRB Cincinnati, Ohio

Continuing Review/Compliance Coordinator

Responsible for the oversight of the protocol deviation reporting process, auditing study status reports from research sites to ensure adherence to federal regulations and IRB policies. Responsible for processing medical license issues submitted by research sites. Responsible for the reapproval process of all sponsor and site files. A key member in the development of Enterprise, the homegrown data base system currently being used at SAIRB as well as the development of policies and procedures.

Responsible for orientation and training of new employees in the department, as well as orientation of our department for employees hired into other departments. Serve on the Quality Improvement (QI) and quarterly QI Data Review Committees.

January, 2003 – May, 2005 University of Cincinnati

Cincinnati, Ohio

Research Coordinator

Responsible for generation and completion of all source documents, drug accountability, query resolution and patient contact throughout clinical study. Initial submission to the client and IRB and follow-up on all SAE’s and Regulatory Documentation. Entry of all CRF’s, including paper and electronic documentation. Development of advertising for clinical studies, including radio, television, newspaper, and internet placement of advertising.

January, 2002 – January, 2003 Kendle International

Cincinnati, Ohio

Senior Clinical Data Associate

Reviews and processes clinical trial data to ensure the accuracy and consistency of clinical databases. Commonly performs the following data related activities: CRF tracking, reviewing, validation, updating, SAE reconciliation, lab data reconciliation and safety coding. Provides accurate, timely, and consistent clinical data to both sponsors and other internal departments to support the business needs of Kendle. Participates in the training of Clinical Data Associates. Reviews and generates ad hoc listings, reports and quality control documentation to facilitate validation of the clinical database.

May, 2001 – January, 2002 University ENT

Cincinnati, Ohio

Research Coordinator

Responsible for generation and completion of all source documents, drug accountability, query resolution and patient contact throughout clinical study. Initial submission to the client and IRB and follow-up on all SAE’s and Regulatory Documentation. Entry of all CRF’s.

January, 2001 – May, 2001 TQM Research

Cincinnati, Ohio

Research Coordinator

Responsible for generation and completion of all source documents, drug accountability, query resolution and patient contact throughout clinical study. Initial submission to the client and IRB and follow-up on all SAE’s and Regulatory Documentation. Entry of all CRF’s.

November, 2000 – January, 2001 Hill Top Research

Cincinnati, Ohio

Research Coordinator

Responsible for generation and completion of all source documents, drug accountability, query resolution and patient contact throughout clinical study. Initial submission to the client and IRB and follow-up on all SAE’s and Regulatory Documentation. Entry of all CRF’s.

September, 1998-November, 2000 Phoenix International

Cincinnati, Ohio

Technical Trainer/Clinical Coordinator

Responsible for training all technicians on in study procedures, including phlebotomy, EKG, vital signs, and patient communication. Training of all staff on GCP guidelines and Sexual Harassment. Developed a mentoring program to allow us to meet increased client demands and allow for senior technicians to assist with training of technicians “on study”.

Education

1991 Hospital Corps School, United States Navy

Great Lakes, Illinois

1991 Field Medical Service School, USN

Jacksonville, North Carolina

1995 University of Cincinnati

Cincinnati, Ohio

2006 University of Phoenix

Phoenix, Arizona

2008 University of Cincinnati

Cincinnati, Ohio

Contact this candidate