Gillin Robinson

Email: abqem8@r.postjobfree.com

Address: ***** ** ***** *****

City: High Springs

State: FL

Zip: 32643

Country: USA

Phone: 386-***-****

Skill Level: Management

Salary Range: $90,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

GILLIAN ROBINSON, PhD

25074 NW 210th Lane, High Springs, FL 32643 386-***-**** (home) 352-***-**** (cell) abqem8@r.postjobfree.com

CLINICAL RESEARCH PROJECT MANAGER

Solid scientific background with extensive and clinical research and project management experience

MISSION

To contribute my integrity, skills, and experience towards the advancement of the collective vision, and the enhancement of health and welfare in the community. To serve with an ethical, quality, and compassion-driven focus.

PROFILE

Quality-focused, analytical and creative professional, proven effective in integrating science and industry with a high commitment to quality and integrity. Equipped with strong written and interpersonal skills and ability to work effectively with individuals from diverse backgrounds. A strong team player capable of effective integration of individual effort into the collective mission.

CORE COMPETENCIES

Clinical Research 13 years

Well versed on all aspects of drug development and clinical research processes

Thorough knowledge of ICH guidelines, GCP, 21 Part 11 and solid foundation in GLP and GMP

Project Management 8 years

Experienced in budget preparation and management, and contract negotiation

Skilled at managing stakeholder relationships, both internal and external, and aligning people to a common vision

Flexible and adaptive to rapid changes inherent in small biotech

Experienced in analysis of dependencies and risks, and developing mitigation strategies

Writing and Communication Skills

Proficient in medical, scientific and technical writing for a broad range of audiences

Experienced in writing Federal grant proposals, scientific papers, reports, manuals, SOPs and literature for non-scientific audiences

Creative in presenting complex ideas in easy-to-digest formats

Skilled at producing clear and concise summaries with attention to detail, quality and overall visual impact

Effective trainer and presenter

PROFESSIONAL EXPERIENCE

The Geneva Foundation, Tacoma, WA 2008 to Current

Project Manager for a non-profit CRO that supports advancement of medical research within the U.S. military

Clinical Trial Project Manager (2008 to March 2012) Subcontracted to Neuren Pharmaceuticals (New Zealand) on a U.S. Department of Defense-sponsored Phase II study evaluating a neuroprotective drug for traumatic brain injury.

Managed all aspects of establishing the clinical protocol at research sites, including site identification, evaluation, selection, initiation and management

Managed relationships with IRBs including the Armys Human Research Protections Office

Developed study procedures, manuals and related materials

Managed communications between sponsor, Principal Investigators, study teams, external vendors, and DoD

Wrote progress reports and presented updates at scientific meetings

Program Manager (March 2012 to current) Working on a Department of Defense program to evaluate potential use of Near Infrared Spectroscopy to diagnose acute compartment syndrome in patients with tibia fractures

Managed all aspects of research at three trauma centers, managed coordinators,

Developed study-related procedures, manuals and data collection forms

Carried out research coordinator activities, including enrolling subjects, collecting data, completing CRFs.

Banyan Biomarkers Inc, Alachua, FL 2004 to 2008

As the second full-time person in this start-up biotech was instrumental in transforming it from a virtual entity into a fully functional R & D company funded by the U.S. Department of Defense to develop diagnostics for traumatic brain injury

Senior Scientist (2004 to 2007); Associate Director of Clinical Studies and Quality Assurance (2008)

Established and managed the clinical research department, including managing a budget over $7million

Managed all aspects of establishing the clinical protocol at research sites in the U.S.A. and Europe, including site identification, evaluation, selection, and initiation; development of contracts and budgets

Developed eCRFs, designed and validated the Electronic Data Capture (EDC) system, including end user acceptance testing, and confirmation of compliance to FDA regulations (21 CFR Part 11)

Pioneered continuous capture and analysis of physiological data

Wrote grant proposals resulting in over $15 million in DoD and SBIR funding (including NIH R-01 and U-01)

Planned and managed preparation for, and presentation of, a DoD-requested American Institute of Biological Sciences review of funded research, resulting in very positive evaluation and continued DoD funding

Analyzed data, presented study updates at scientific meeting, and wrote reports to funding agencies

Guided setup of preclinical drug evaluation lab for potential neuroprotective new molecular entities

Santa Fe Community College, Gainesville, FL 2002 to 2004

Adjunct Professor of Anatomy and Physiology for students going into medical fields

Developed effective and high impact study tools and presentations to aid in student learning

Consistently ranked highest instructor in Department by student evaluations

University of Florida, Gainesville, FL 1999 to 2003

Regulatory Affairs Specialist ensuring web-based clinical research EDC system was compliant to FDA requirements

Designed and validated software components for compliance with 21 CRF Part 11 and GCP,

Designed EDC system for preclinical research management, including GLP compliance

Established Quality Unit for validation and verification of software components

Conducted end user testing and software troubleshooting

EDUCATION AND CREDENTIALS

PhD in Reproductive Physiology UNIVERSITY OF OTAGO Dunedin, New Zealand

Research performed in conjunction with U.S. National Institutes of Health (NIH)

Post-graduate Scholarship from N.Z. Medical Research Board

Medical Research Travel Award from N.Z. Medical Research Board

Best Junior Presentation at the N.Z. Endocrine Society

Resulted in 6 peer-reviewed publications, 4 published abstract

BSc with Honours in Physiology UNIVERSITY OF CANTERBURY Christchurch, New Zealand

Advanced Masters Certificate in Applied Project Management VILLANOVA UNIVERSITY Online Completion expected June 2013, with preparation for PMP certification.

Certificate in Medical Research Administration GEORGE WASHINGTON UNIVERSITY Washington DC

Certified Clinical Research Professional SOCIETY OF CLINICAL RESEARCH ASSOCIATES (SoCRA)

TECHNICAL SKILLS

Microsoft Office (Word, Excel, Access, Publisher, PowerPoint)

Adobe (Acrobat, Photoshop, Illustrator)

PUBLICATIONS 26 peer-reviewed 25 published abstracts 3 book chapters

CITIZENSHIP New Zealand/Australia United States European Union

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