SUMMARY OF QUALIFICATIONS

Over ** years of clinical research experience. Dependable, thorough, and well-organized Clinical Research Professional with strong written and oral communication, leadership and mentoring skills. Proven ability to work with minimal supervision, display good judgement, risk analysis, and decision-making in the practical implementation of studies. Knowledge of clinical trials. Ability to work effectively in a matrix multicultural environment.

THERAPEUTIC EXPERIENCE:

20 yrs. CRA

Diabetes- Phases I, II

Clostridium Difficile Vaccine- Phase III

Alzheimer’s disease- Phases II & III

Atopic Dermatology - Phase IIIB

Ulcerative Colitis- Phase III

Pain Management- Phase II

Osteoarthritis- Phase III

RSV Vaccine for Pregnant Women- Phase III

HIV- Phase III

Diabetes- Phases II & III

Varicella Zoster Virus Vaccine- Phase I & II

Covid Vaccine -Phase I/II

Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) certifications

Excellent Site facing and management skills

Assisted protocol team lead with development of SIV slides, monitoring plans, and site visit report annotations

Presenter at Team Meetings

Computer skills including proficiency in Microsoft Office -Word, Excel and Power Point

Electronic Data Capture Systems; InForm, Medidata Rave and Oracle .

Regulatory Document Management (TMF): Veeva Vault, Florence Systems

Interactive Web Response Systems (IWRS) Impala, Interactive Voice Response Systems

Clinical Trials Management Software (CTMS) InFormant and Veeva Vault

PROFESSIONAL EXPERIENCE

Principal Clinical Research Associate ICON APR 2015 – JUN 2023

Lead CRA interventional vaccine study

Perform site initiation, interim monitoring and close-out visits in accordance with contracted scope of work and good clinical practice

Site management and oversight

Prepare accurate and timely trip reports

Administer protocol and related study training to assigned sites

Establish regular lines of communication with sites to manage ongoing expectations and issues

Collaborate and liaise with study team members for project execution support as appropriate

Assist with training, mentoring, and development of new CRAs

Participated on committees providing job support and ongoing therapeutic area training

Conducted monitoring visits at Canadian and Puerto Rico sites during staffing shortage

Senior Clinical Trial Associate Quintiles, Atlanta, GA JAN 2012 – DEC 2014

Trained new Clinical Assistants on study related processes and procedures

Maintained and managed data entry into clinical tracking systems

Prepared regulatory submissions for Independent Ethics Committees or Institutional Review Boards

Coordinated process for sending Investigator brochures and IND Safety reports to study sites

Performed in-house monitoring using Electronic Data Capture

Coordinated project activities associated with study start-up of global RSV trial

Conducted audits of in-house clinical study files

Conducted study specific monitor training

Evaluated field performance of monitors

Reviewed monitoring trip reports

Moderated clinical team meetings

Provided performance feedback on co-workers to management

Conducted study specific monitor training

Evaluated field performance of monitors

Reviewed monitoring trip reports

Clinical Research Associate United BioSource Corporation March 2011- Dec 2011

Conducted CRA activities on Phases III, & IV clinical trials

Selecting, Initiating, Monitoring and Close-out of clinical research sites

Ensured the integrity of Case Report Form data through the verification of Source Documentation

Performed Drug Accountability

Conducted Regulatory Document reviews

Assisted monitoring team with visit schedules and tracking, proof reading of trip reports and assembly of documents for transmittal to sponsor(s)

Clinical Research Associate BIODEL INC Nov 2007 to January 2011

Managed Phases I, II & III Diabetes clinical trials

Managed clinical study timelines, deliverables and risks

Collaborated with manufacturing regarding readiness of supplies, labeling and shipping of investigational product.

Created vital study documents and supervised creation of study documents.

Maintained awareness of local and international regulatory requirements

Point of contact to principal investigators

Oversee CRO activities to ensure that Protocol and Monitoring Plan are appropriately implemented.

Oversee activities of in-house CRAs

Conducted study specific monitor training.

Evaluated field performance of monitors.

Reviewed monitoring trip reports.

Moderated clinical team meetings.

Provided performance feedback on co-workers to management

Pharmacy Technician New York Presbyterian Hospital-Clinical Pharmacy New York. NY

1996-2002

Clinical Research Associate Rockefeller University Hospital-Investigational Pharmacy

New York, NY 2002-2007

EDUCATION

Long Island University, Brooklyn, NY

Richard L Connolly College of Liberal Arts & Sciences & Arnold & Marie Schwartz School of Pharmacy, Brooklyn Campus

BS, General Sciences.

1997-2002

AFFILIATIONS

Association of Clinical Research Professionals

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