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Medical Device Clinical Research

Location:
Somerville, NJ, 08876
Posted:
August 23, 2012

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Resume:

Shirley M. Francisco

** ***** ****** *****: 281-***-****

Somerville, NJ 08876 Mobile: 832-***-****

Email: bbedaw@r.postjobfree.com

EDUCATION:

•Doctor of Medicine

Fatima College of Medicine, Manila, Philippines 1979-1983

•Bachelor of Science in Biological Sciences

University of the East, Manila, Philippines 1974-1979

AFFILIATIONS/TRAINING/CERTIFICATION:

•SoCRA Certified Clinical Research Professional

•Coordinating Clinical Trial Seminar, Coral Springs FL, Jan. 11-12, 2008

•Adverse Drug Events – Reporting and Regulatory Requirements Seminar, Malvern PA, Dec.13-14, 2007

•Clinical Research Associate and Coordinator Training Program

Raritan Valley Community College, NJ, 2002

WORK EXPERIENCE:

07/23/12 to Coastal Ear Nose and Throat, Neptune, NJ

Present CLINICAL RESEARCH COORDINATOR

06/09/ to University of Texas Medical Branch, Galveston, TX

07/03/12 CLINICAL RESEARCH COORDINATOR

•Coordinate clinical trials in Internal Medicine and Ophthalmology..

•Preparation and submission of protocols, informed consents and other study related documents for local IRB approval

•Processing and submission of IND safety reports, adverse events, protocol deviations to local IRB

•Direct assistance to Principal Investigator in the organization and maintenance of clinical trial processes and data.

•Ensure that clinical trials are being conducted in compliance with the protocol, GCP and ICH guidelines

•Maintain Clinical Trial Agreements, Regulatory Binders, Study Documentation and Communications for each Clinical study.

•Reviews patient’s medical records and evaluates for eligibility according to the protocol’s inclusion and exclusion criteria

•Conduct subject visits, including scheduling, obtain written informed consent, completing of subjects assessments, collection and processing of biological samples, blood, urine), medical testing ( vital signs, ECG, etc)

•Process and ships human specimens and biological samples according to study specific laboratory manual guidelines

•Collaborates with the sponsor’s study team, clinical research organization team, central laboratory, site’s research team, local IRB

•Participates in monitoring and auditing activities to ensure completeness and accuracy of data

•Responsible for completion of source documents and case report forms, responsible for resolving of queries and submission in a timely manner

•Experience with electronic data capture such as Medidata RAVE, Inform, and interactive voice response system (IVRS)

•Responsible for storage, maintenance and tracking of clinical supplies

12/02 to Clinical Research Laboratories, Inc., Piscataway, NJ USA

1/14/08 RESEARCH MANAGER/STUDY COORDINATOR

•Performed as Manager and Clinical Research Coordinator in multi disciplined clinical studies and in addition to the duties of a Clinical Research Coordinator are the following:

•Protocol evaluation and feasibility including study budget negotiation

•Clinical trial preparation involving the planning, assembling and instructions of the clinical trial team

•Implementation of clinical trial from initiation through close out Primary contact for communications with Pharmaceutical companies, CRO, the IRB and the central laboratory to ensure successful conduct of assigned clinical trial.

•Selection of Principal Investigator as needed

•Primary contact for communications with Pharmaceutical companies, CRO, the IRB and the central laboratory to ensure successful conduct of assigned clinical trial.

•Work with Phase II – IV clinical trials in Ophthalmology, Dermatology, Allergy and Phase I clinical trials for medical device

•Preparation and submission of regulatory documents to sponsor and central IRB and assure completeness of the these documents on file for all clinical trials

•Performed as Clinical Investigator in clinical studies involving gynecology and dermatology for cosmetics, personal care and non-FDA regulated products.

•Coordinate protocol and informed consent development for over the counter, personal care products and medical device studies.

8/02 to Portamedic, Cranbury, NJ, USA

12/02 PARAMEDICAL EXAMINER

9/88 to Shirley Mangilit-Francisco Medical and Maternity Clinic, Quezon City,

4/02 Philippines GENERAL PRACTITIONER/OWNER

7/88 to Fabella Memorial Hospital, Manila, Philippines

9/88 OBSTETRICS AND GYNECOLOGY RESIDENT PHYSICIAN



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