Contract CRA - Biotech Resume Search
Contract CRA - Biotech Resume Search
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Contract CRA Resume


Desired Industry: Biotech SpiderID: 5266
Desired Job Location: austin, Texas Date Posted: 2/4/2006
Type of Position: Contractor Availability Date: 02.02.06
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, More Than 75%
Highest Degree Attained: Bachelors Willing to Relocate: Yes


Experience:
Experience Lau Research Consultants, Inc.
Independent Clinical Research Associate, February 2006 – Present
• Develop, implement, and manage pharmaceutical clinical research
projects
• Develop CRF/Source/tools
• Site Selection/Management
• Budgets/Grants
• Regulatory Management
• Overall Study Management
• Clinical Monitoring in accordance with Sponsor Protocols and
Federal regulations
• Pre-study, initiation, interim, and close out
• Provide Training for CRA’s and investigators
• Aided in developing field monitoring training program
• Aided in developing CRC training manual
• Aided in Investigator meetings
• Training for eCRF systems
• Conduct and Participate in Pre FDA/Quality Assurance audits
• Ensure overall adherence of FDA, GCP, and ICH guidelines

Clinimetrics, San Jose, CA (based in Austin, TX)
Regional Clinical Research Associate II, August 2005 – Present
• Manage multiple centers in US and ensure the quality and integrity of clinical trails by performing and coordinating all aspects of clinical monitoring or case report forms, study and source documents for their accuracy and protocol adherence in accordance with GCP/ICH guidelines and global SOP’s to assess the safety and efficiency of investigational products
• Organize and perform various monitoring visits, including initiation, interim, and closeout visits
• Responsible for writing clinical summary reports on multiple study formats
• Responsible for training new CRA’s
• Assist in assigning projects between CRA’s
• Work independently from a home office and treated as an independent monitor.

Chiltern International, Austin, TX
Clinical Research Associate II, January 2005 – August 2005
• Performed and coordinated all aspects of the clinical monitoring process in accordance with GCP/ICH guidelines and global SOP’s to assess the safety and efficiency of investigational products
• Organized and performed various monitoring visits, including initiation, interim, and closeout visits
• Responsible for writing clinical summary reports on multiple study formats
• Responsible for training new CRA’s
• Assisted in assigning projects between CRA’s
• Involved in budget review for clinical monitoring costs

Chiltern International, Austin, TX
Clinical Research Associate, September 2004 – December 2004
• Liaison between Project Manager and Principal Investigator and staff
• Assisted in preparation of Ethic Committee submissions
• Managed multiple centers in US and ensured the quality and integrity of clinical trails by performing and coordinating all aspects of clinical monitoring or case report forms, study and source documents for their accuracy and protocol adherence in accordance with GCP/ICH guidelines and global SOP’s to assess the safety and efficiency of investigational products
• Conducted all aspects of monitoring, including initiation, interim and close out visits
• Documented all study activities including investigator contacts using
relevant forms
• Primary support for the Project Manager
• Liaise with Project Leader and CRAs effectively
• Assembled, maintained and audited documents in central files in order to accurately reflect the progress of the study and ensure compliance with GCP and internal/Sponsor SOPs

Pharmaceutical Products Development Inc. (PPD), Austin, TX
Clinical Research Coordinator, January 2004 – September 2004
• Conducted multiple ongoing clinical trials involving patients or healthy volunteers
• Prepared all paperwork required by study protocol
• Insured subject safety and cooperation during procedures
• Coordinated four studies, with two groups consisting of sixty-four
subjects, one being an IV study, and the last one being a QTC intensive
study
• Therapeutic areas in CNS, oncology, diabetes, and cardiology
• Trained as a Clinical Data Analyst to transcribe CRF’s and eCRF’s

St. David’s Medical Center, Austin, TX
Patient Care Technician II – student nurse, May 2003 – February 2004
• Responsibilities included: bed making, feeding, hygiene, application of heat and cold, ambulation and transfer, restraints, positioning, obtaining specimens, TED hose, active and passive ROM, adjust O2 mask, nasal cannula, assist with elimination and perineal care, clerical duties, vital signs and weights, SCD, oral suctioning, finger stick blood sugar/glucometer, monitor and report O2 stats, hemoccult, gastroccult, respiratory procedures, CPM, overhead trapeze, stage two wound care, order entry, all transfers, patient lifts, catheters, phlebotomy, sterile procedures, and enemas

Pharmaceutical Products Development Inc. (PPD), Austin, TX
Research Technician, August 2001 – August 2003
• Worked with normal healthy subjects participating in research studies on new developmental drugs through pharmacokinetic procedures
• Demonstrated knowledge of phlebotomy, vitals, ECG’s, patient care, meal monitoring, neuropsychometric testing, and data collection

Southwestern Company, Nashville, TN
Independent Dealer, Monroe, Michigan, May – August 2001
• Sold educational books, door-to-door, on commission
• Worked a minimum of eighty-six hours each week
• One of twenty UT students chosen by the company’s top delegates to participate in this strenuous summer internship


Education:
Education The University of Texas at Austin
Bachelor of Science, December 2003
Human Development and Family Sciences

Austin Community College
Associate Degree in Nursing (two year background)


Skills:
Certified in Pediatric/Adult CPR and First Aid
Computer experience: Microsoft Word, Microsoft Excel, Oracle, and Electronic Data Capture (EDC)


Candidate Contact Information:
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