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Senior, Clinical Research Associate

Location:
Broadway East, Maryland, 21213, United States
Posted:
May 25, 2018

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Resume:

Michael Grant Webb

Home telephone: 443-***-**** Email: ac5l6x@r.postjobfree.com

OBJECTIVE: To obtain a position that will utilize my education, skills and knowledge as a means of achieving organizational goals, while providing a defined career path for advancement opportunities.

HIGHLIGHTS of SKILLS and QUALIFICATIONS

• Personal characteristics - Dedicated, detail oriented, approachable personality and professional attitude

• Gained numerous opportunities to exhibit effective communication and interpersonal skills

• Accumulated seven years of wet lab experience; eight years of supervisory and staff management experience; and twenty years of experimental, behavioral and social science research experience with two years dedicated to performing pharmaceutical clinical client audits

• Assessed and documented select medical research laboratories and pharmacies research capabilities via pre-study qualification and assessment visits and the reviews of documented practices, processes and procedures (e.g. data management and staff training) in addition to interviews of key site personnel

Coordinated the start-up and execution of human subject research in select research facilities or institutions via initiation, interim monitoring and study close out visit activities

• Reviewed, confirmed and reported select investigative research facilities or institutions compliance with the Code of Federal Regulation and mandates of the International Conference on Harmonization (ICH), Guidelines of Good Clinical Practice (GCP), and Institution Review Board guidelines as applied to human subject research and testing

• Reviewed and validated select research facilities or institutions subject recruitment processes and subject eligibility via reviews of Informed Consents and historical medical data (e.g. charts /EMR)

• Reviewed all other human subject research data to identify erroneous, missing, incomplete or implausible data

• Reviewed, confirmed select research facilities or institutions gathering and submission of essential study documents and materials to the local or central IRB via study file binder and trail master file reviews

• Reviewed and confirmed select investigative research facilities and institutions data management adequacies, quality assurance and control processes and overall validation processes

• Received and prepared narratives from reported Serious Adverse Events (SAE) for submission to appropriate Data and Safety Monitoring Boards (DSMB).

• Conducted central laboratory and contract research organization quality assurance audits of proprietary IT Systems, development, lifecycle and integrity of the clinical data collection processes, data storage and recovery procedures

Quality control audits included extensive SOP reviews and critiques in the areas of SOP development, personnel / training, analytical lab equipment usage and maintenance, human specimen management in a lab setting, data management, confidential data storage management, data recovery plans and internal the validations processes

• Evaluated and documented assessments of investigative select facilities or institutions operating budgetary (incld. patient payments) compliance

• Documented select investigative facilities or institutions compliance and proper use of outside vendors performing contracted task (e.g. long-term data storage)

• Performed preliminary data analyses and prepared graphic representations of research data results.

• Developed with the Java Programmers, case reporting forms (CRF) and prepared CRF and monitoring guidelines

• Developed with the investigative staff, phase II psychiatry (behavioral) protocol procedures and data management guidelines

Conducted quality assurance reviews of Investigative study's Clinical Study Reports

• Executed auditing assignments in both domestic and international environments.

• Experienced in developing and producing multimedia presentations and training videos

February 2013 – July 2017

SENIOR CLINICAL RESEARCH ASSOCIATE

ICON Clinical Research, North Wales, Pennsylvania

July 2011 – January 2013

CLINICAL RESEARCH COORDINATOR/ASSOCIATE

Clinical Trials and Surveys, Corporation, Owings Mills, Maryland

July 2010 – July 2011

SENIOR CLINICAL RESEARCH ASSOCIATE

i3 Research, Cary, North Carolina

August 2009 – Present

KEY GRIP/ EDITOR

2 Smart Productions, Baltimore, Maryland

March 2010 – June 2010

ENUMERATOR / ASSISTANT CREW LEADER

U.S. Department of Commerce, Census Bureau, Baltimore, Maryland

Mar 2008 – June 2009

REGIONAL CLINICAL RESEARCH ASSOCIATE

Kendle International, Inc., Cincinnati, Ohio

June 2006 – Feb 2008

SENIOR CONSULTANT

Falcon Consulting Group, LLC, Exton, Pennsylvania

July 2005 - June 2006

REGIONAL CLINICAL RESEARCH ASSOCIATE

MDS Pharma Services, Irvine, California

April 2002 - July 2005

REGIONAL CLINICAL RESEARCH ASSOCIATE

SCIREX Corporation, Horsham, Pennsylvania

March 2000 – April 2002

REGIONAL CLINICAL RESEARCH ASSOCIATE

April 1998 - March 2000

CLINICAL RESEARCH ASSISTANT / ASSOCIATE

Covance Clinical and Periapproval Services Inc., Princeton, NJ

August 1993 – April 1998

RESEARCH PROGRAM COORDINATOR

January 1990 - August 1993

SUPERVISOR OF DATA COLLECTION

Johns Hopkins University

Behavioral Pharmacology Research Unit, Baltimore, MD

February 1985 - December 1989

LABORATORY SCIENTIST

University of Maryland

School of Pharmacy, Baltimore, MD

Therapeutic Area

Indication(s)

Phase(s)

Renal / Urology

Overactive Bladder

III

Pharmacology

Pharmacokinetics/Pharmacodynamics

I & II

Respiratory

Community Acquired Pneumonia

III

Asthma

II

Cardiovascular

Hyperlipidemia

III

Hypertension

III

Deep Vein Thrombosis

& Pulmonary Embolism

Safety & Efficacy

Musculoskeletal

Chronic Low Back pain

Osteoarthritis - Knee & Hip

II & III

Osteoporosis

III

Rheumatoid Arthritis

IIIB & IV

Oncology

Myelodysplastic syndromes

II

Acute Leukemia AML/APL

Compassionate Use

Newly Diagnosed Multiple Myeloma

III

Gastrointestinal

Diverticulitis

III

Neurological

Pediatric Refractory Complex Partial Seizures

III

Post-Operative Pain (Bunionectomies)

I

Orthopedic

Gram negative skin and soft tissue infections

IV

Vaccine

Anthrax

Immunogenicity/ Safety

Cytomegalovirus

II

Enterotoxigenic Escherichia coli

Immunogenicity/ Safety

Human papillomavirus (HPV)

Immunogenicity

Hepatitis C

I & II

Influenza

Immunogenicity/ Safety

Leishmaniasis (caused by protozoan Parasites)

I

Shigellosis (caused by Bacterial S. sonnei)

Immunogenicity/ Safety

Small Pox

II

- Oracle Clinical: Remote Data Capture - Rave Medidata

- eClipse Electronic Data Capture - Inform 5.5

- Dynarand / United BioSource Corp - ClinPhone

- Epic - Rees Scientific

Master of Business Administration

Concentration: Management

The Johns Hopkins University, Baltimore, MD

Master of Administrative Science

Concentration: Management and Information Technology

The Johns Hopkins University, Baltimore, MD

Bachelor of Arts

Concentration: Biology Minor: Biochemistry

University of North Carolina @ Asheville, Ashville, NC

OTHER SKILLS: Familiar with various Macintosh and PC software packages: Microsoft Excel, Word, Outlook

and Power Point. Audio/Visual Services Hardware/Software: Digital Beta, HD, 16/35mm film,

CD/DVD duplications, Adobe Premiere Pro and WaveLab.

CITIZENSHIP: United States of America

REFERENCES: Furnished upon request



Contact this candidate