Project Clinical Research

Gayl Selkin-Gutman, M.A. *****@*****.*** 301-***-****

CLINICAL RESEARCH PROFESSIONAL

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More than ten years' clinical research experience including

implementation, protocol development, planning, management and site

monitoring. Organized, strategic thinker with a systematic approach.

Innovated process improvements and tools that increased efficiency.

Committed to excellence in clinical research. Multilingual.

COMPETENCIES

Project Leadership Analytical Problem Solving Human Subjects

Research

Protocol Development Skilled Writer/Editor NIH Experience

Strong Communication & Organizational Skills GCP, FDA and IRB

Regulations Expertise

EXPERIENCE & SELECTED ACCOMPLISHMENTS

Senior Recruitment Specialist, MMG, Rockville, MD 2011

Performed recruitment and retention assignments for national and

international clinical research studies.

Senior Study Manager, WESTAT, Rockville, MD 2003 - 2008

As Protocol Specialist: Collaborated with multidisciplinary project teams

to develop and write clinical research protocols in compliance with Good

Clinical Practice (GCP) and all applicable regulatory requirements.

Developed and facilitated adherence to project timelines. Prepared

training materials and implemented protocol specific training for clinical

site staff. Drafted informed consents and protocol sections. Developed

surveys & questionnaires. Identified and resolved potential impediments to

study progression. Served as primary point of contact for staff at

multiple research sites.

* Initiated a Quality Control (QC) tool to streamline the internal

protocol review process. This evolved into a 100+ item Protocol Review

Checklist that became part of our division's Standard Operating

Procedures (SOPs) and contributed to more effective, efficient reviews

of protocols and study documents.

* Revised a Protocol Development and Implementation Procedure and

prepared project-specific protocol templates that guided the efficient

development of subsequent project protocols. This resulted in the

timely finalization of quality protocol documents that met all

regulatory and IRB standards.

* Innovated a work instruction for CRF development that streamlined

subsequent project-related CRF development.

* Effectively coordinated and developed protocols for six

nationally-implemented clinical research trials in Adolescent HIV/AIDS

research and contributed to multiple other studies - resulting in

numerous publications in peer reviewed journals.

* Reviewed site readiness and oversaw site activation. Developed

training materials and protocol tools to assist sites in the conduct of

clinical trials. Trained site staff regarding protocol-specific

procedures and SOPs.

* Wrote sections of winning proposals and contributed to budget

planning for clinical sites.

* Revised and significantly improved a Manual of General Operations

for a national research network for Adolescent HIV/AIDS research.

* Supervised and oriented new and junior staff members to complex

procedures and existing resources.

As CRA/ Site Monitor: Acted as liaison between clinical site, data

management and regulatory affairs staff. Conducted site monitoring

visits and pharmacy audits for IND study. Essured adherence to the

protocol, SOPs, GCP and FDA/ICH regulations. Verified appropriate

regulatory documents and accurate reporting of adverse events (AEs).

Wrote detailed Site Monitoring Visit reports highlighting compliance

concerns; recommended remedial actions.

* Developed tools to efficiently monitor recruitment, enrollment, AEs

and implementation issues for more than 200 study participants,

incorporated and reconciled data from multiple sources.

* Provided supplemental training to facilitate accurate protocol

implementation and adherence to regulatory requirements throughout the

study.

* Edited seven quarterly newsletters to promote participant retention

and adherence to study requirements. Used creative communication to

keep publications on schedule.

Psychology Associate, William Stixrud and Associates, Silver Spring, MD

2000- 2003

Evaluated over 300 pediatric and adult clients with learning

disabilities, attention deficit hyperactivity disorder and other

conditions using extensive neuropsychological and psychoeducational

test batteries. Analyzed and summarized test results. Wrote clinical

reports.

Research Psychometrician, Medical Illness Counseling Center 1992-

2000

Implemented Phase I and Phase II clinical trials as part of a

multidisciplinary team at the National Cancer Institute, Pediatric

Branch. Conducted protocol-specific neuropsychological assessments

with over 200 pediatric HIV patients and their families. Administered,

scored, analyzed and presented results at staff meetings. Prepared both

research and clinical reports. Conducted the informed consent process

and enrolled patients in studies.

* Proposed and developed 16 test administration guides that

streamlined evaluation procedures.

* Initiated and wrote a manual for analyzing patient contact data and

preparing contract reports.

* Recommended and supervised the transition to computerized

recordkeeping. Developed a data coding system.

EDUCATION and TRAINING

M.A., Clinical Child Psychology, Tel Aviv University, Israel

B.A., Psychology, State University of New York at Binghamton

Good Clinical Practice (GCP): from Development to Application, SOCRA,

2010

Monitoring Clinical Drug Studies: Beginner, Barnett International, 2005

Clinical Research Associate Training, Westat, 2005

National Institutes of Health, Computer Security Awareness, 2005

Good Clinical Practices (GCP) Training Certificate, Westat, 2004

Preparing for an FDA Inspection, ACRP Conference, 2003

Human Subjects' Protection Training (2003, with annual renewals)

AWARD

NIH Volunteer Recognition: for providing interpretation service for

Hebrew speaking patients and their families.

COMPUTER SKILLS

Proficient in the use of Microsoft Office Product Suite (Outlook,

Excel, Word, PowerPoint) and Adobe Professional. Familiar with

protocol management systems and Statistical Analysis Software (SAS).

Demonstrated ability to master new office automation tools.

LANGUAGES

English, Spanish, Hebrew, Russian

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