Clinical Compliance Associate - Biotech Resume Search
Clinical Compliance Associate - Biotech Resume Search
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Clinical Compliance Associate Resume


Desired Industry: Biotech SpiderID: 48388
Desired Job Location: Media, Pennsylvania Date Posted: 2/22/2011
Type of Position: Full-Time Permanent Availability Date: Immediately
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: High School/Equivalent Willing to Relocate: No


Objective:
Multi-faceted supervisor with strong organizational skills, leadership experience and attention to detail. Expert in areas of facilitating coordination among multiple offices to successfully handle requests for documents. Experienced problem solver with excellent time management skills. This experience was primarily working within a large university setting at one of the oldest colleges in the United States. My experience includes study coordination, and supervisory management in Phases II, III and IV clinical research trials on several large multi-national studies across the United States, Canada and Europe for the indications of anxiety, depression, social phobia, and substance abuse trials.



Experience:
WORK EXPERIENCE
Quintiles, Inc
Senior Clinical Research Coordinator 2008- April 2010

• Assist partner sites in determining study feasibility
• Preparation and maintaining of regulatory documents, site selection visits
• Assist with recruitment, reviewing patient charts for inclusion/exclusion criteria
• Assist principal investigator in completing informed consent process
• Coordinate subject visits, subject interview and assessments under the direction of the principal investigator
• Review source documents to assess compliance with study procedures and GCP guidelines. Maintain progress notes
• Scheduling and preparing for CRA monitoring visits
• Receive, inventory, and storage of investigational product. Dispensing, reconciling, investigational product
• Perform phlebotomy, process and ship laboratory specimens as well as perform EKG’s
• Mentor less experienced coordinators and provide guidance to less experienced Principal Investigators
• Electronic Data Capture
• Perform site visits as appropriate


University of Pennsylvania Philadelphia, PA
Mood and Anxiety Disorders Section, Department of Psychiatry 1983 - 2008
Office Manager/Senior Clinic Coordinator, CNS Research
• As senior coordinator responsible for high volume telephone interaction with patient inquiries to clinical trials.
• Contact with representatives of the pharmaceutical companies, answering questions regarding all aspects of the studies
• Manage multiple adult, child and adolescent clinical research trials for the treatment of anxiety, depression and social
anxiety disorder
• Implement and ensure protocol adherence to established guidelines, prepare study material and medication; document
and report adverse events; ensure drug accountability
• Provide statistical summaries and reports of progress on monitored studies, conduct frequent field monitoring of studies, problem solving for quality assurance at participating satellite sites
• Conduct periodic reviews of monitoring to assure quality and make recommendations for improvement of procedures to
the principal investigators
• Review and audit case review forms, identify patient deviations, data inconsistencies and generate queries, while ensuring
strict adherence to FDA and Sponsor guidelines
• Supervise and train all newly hired research coordinators and administrative staff, conduct daily consultations with medical staff to maintain unit productivity, provide feedback and guidance to all staff
• Prepare regulatory document submissions, i.e., adverse events, annual review and FDA 1572

University of Pennsylvania (continuation)


• Conduct telephone and questionnaire screening of potential patients for study specific eligibility, track and report patient recruitment
• Assure correct completion of protocol research forms; coordinate patient study visits; maintain patient records, also responsible for taking vitals, preparing laboratory specimens for shipment and performing EKG’s


Education:


EDUCATION
Pennsylvania State University State College, PA 1974-1977
Completed three years of course work towards a degree in psychology




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