Clinical Research Associate

Kristine Matacchiera

Medford, NJ ***** 845-***-**** ************@*****.***

Summary

Clinical Trial Professional with a strong background in regulatory and study related documents. Broad range of experience in therapeutic areas and trial phases working from both a Pharmaceutical and Vendor perspective. Ability to work both independently and as a team member.

Education

MASTERS OF SCIENCE- BIOLOGY JANUARY 2013 LONG ISLAND UNIVERISTY

BACHOLOR OF SCIENCE- BIOLOGY DECEMBER 2008 ROWAN UNIVERSITY

Skills

Demonstrated knowledge and experience in regulatory documents

Ensuring audit readiness of Investigator and Local Study Files

Quickly able to learn new CTMS, EDC, IVRS systems

Experience with sites both Globally and in U.S. in supply shipment and query resolution

Experience

CLINICAL REASEARCH ASSOCIATE I PRA HEALTH SCIENCES JULY 2017- PRESENT

Monitors clinical trials to ensure sponsor and investigator obligations are met and comply with applicable local regulatory requirements and ICH-GCP guidelines

Conducts Pre-Study (Qualification), Site Initiation, Interim and Close-Out monitoring visits

Reviews and verifies accuracy of clinical trial data collected

Updates applicable tracking systems

Performs essential document site file reconciliation

Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues

Provides regular site status information to team members, trial management, and updates trial management tools

Assesses IP accountability, dispensation, and compliance at the investigative sites

IN-HOUSE CRA PRA HEALTH SCIENCES JANUARY 2016-JULY 2017

Attend and support U.S investigator meetings and local team trial meetings

Collect and coordinate completion of study documents, track IRB approval, and all documentation required for site start-up

QC of documents and review of site and U.S Master file to ensure compliance with GCP and ICH

Assist with site-feasibility, site start-up, pre-site selection visits, site selection, site initiation, and monitoring visits

Main contact for vendors and ordering of supplies for trial

Responsible for site and investigator payments

ASSISTANT CLINICAL PROJECT MANAGER BIOCLINICA JANUARY 2014-JANUARY 2016

Assisted in the management and start-up of 9 oncology clinical trials from Phases Ib-3

Draft and finalized project protocol documents

Provided team leadership including team training, communication, and delegation

Analyzes site and data trends, making recommendations to Project Manager when necessary

Reviewed and edited site training presentations and tracked completion by sites

Generated, tracked, and resolved data queries

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