Marie Smith

Email: abpi0j@r.postjobfree.com

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

City: Philadelphia

State: PA

Zip: 19151

Country: USA

Phone: 484-***-****

Skill Level: Experienced

Salary Range: $70,000

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Marie Smith, BS

6351 Lebanon Avenue

Philadelphia, PA 19151

Telephone: 484-***-****

abpi0j@r.postjobfree.com

EDUCATION

STRAYER UNIVERSITY, Springfield, PA

2011 - Present: Master`s Program Health Services Administration

SAINT JOSEPH UNIVERSITY, Philadelphia, PA,

1998 - BS Human Services Administration

PROFESSIONAL EXPERIENCE

RESEARCH PHARMACEUTICAL SERVICES, INC, Fort Washington, PA

(2005-2011)

Clinical Research Associate - Coordinate all operational aspects of the study and participate in the activities that ensure quality of the study data and deliverables from study start-up to data base lock. Process, track, and reviewed investigator regulatory documents. Review and approved informed consents. Worked closely with data management and field operations to manage ongoing data retrieval from sites and resolve data issues to include queries and data clarification reports. Coordinate data cleaning activities in support of database lock. Maintain excellent communications with study team and with management, investigational sites and vendors across all aspects of the organization. Manage multiple sites in-house to ensure study activities are conducted in accordance with the protocol, SOPs and ICH/GCP guidelines.

PRA INTERNATIONAL, Horsham, PA (2002 - 2005)

Clinical Operations Specialist - Ensure sponsor and investigator obligations are met and in compliance with applicable regulatory requirements and ICH/GCP guidelines. Conduct initial, routine, and close out monitoring visits. Conduct source document verification of case report forms against medical records; Generate monitoring visit reports in a timely fashion

Coordinate presentations and assisted with the preparation and attendance at Investigator meeting. Process, track and review investigator regulatory documents for approval for drug release

DEVON CONSULTING, Wayne, PA (2001-2002)

Clinical Research Associate - Process, track, and review investigator regulatory documents. Assemble and organize clinical study documents for IRB submission and internal regulatory approval and drug release.

GENOMICS COLLABORATIVE, INC., Blue Bell, PA (2000-2001)

Clinical Research Associate - Recruit investigators for participation in clinical trial, process, track, and review regulatory documents, conduct pre-study, initiation, and interim co-monitoring visits, coordinate and assemble study initiation packages, and study reference manual to investigator sites. Created and maintain essential components for study master file

UNIVERSITY OF PENNSYLVANIA (PRESBYTERIAN HOSPITAL), Philadelphia, PA (1998 - 2000) Surgical Administration

Administrative Coordinator - Manage all administrative functions in Surgical Administration office. Coordinate materials and provide orientation to new rotating physicians. Served as liaison between surgery and medical affairs for verification and processing of credentials. Coordinate physicians OR schedules to ensure adequate coverage.

HOSPITAL OF THE UNIVERSITY OF PENNSYVANIA (HUP), Philadelphia, PA (1990 - 1998)

Multi-organ Transplantation (Liver and Kidney)

Administrative Coordinator - Responsible for coordinating and scheduling clinical activities associated with pre and post transplant recipients. Requested and tracked clinical information from referring physicians, dialysis units and hospitals for kidney transplant candidates and donor families. Reviewed clinical information for completeness and entered data into computer. Abstracted clinical data from medical records of patients and summarized into patient profile. Tracked and charted clinical data after kidney transplant evaluation.

References Available Upon Request

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