Senior/Lead Clinical Research Associate Resume
|Desired Industry: Biotech
|Desired Job Location: Washington, District of Columbia
||Date Posted: 11/20/2008
|Type of Position: Full-Time Permanent
||Availability Date: ASAP
||U.S. Work Authorization: Yes
|Job Level: Experienced with over 2 years experience
||Willing to Travel: Yes, 50-75%
|Highest Degree Attained: Masters
||Willing to Relocate: Undecided
Looking for a Senior/Lead CRA position, preferably home-based.
Exelixis, Inc., South San Francisco, CA July 2007 – present
Regional Clinical Trials Manager
• Performed essential CRA and/or Clinical Trial Manager job functions, with emphasis on the primary responsibilities related to increasing enrollment performance at key investigative sites
• Identified, contacted, developed and maintained relations with Key Opinion Leaders (KOLs), investigative sites, and patient education groups
• Provided scientific support for company projects, presenting to investigative sites
• Monitored CRO performance to assure protocol compliance
• Assisted in the identification, selection and initiation of sites
• Visited clinical sites to establish direct company contact with investigators and their study personnel,
• Visited clinical sites to assure regulatory compliance with company SOPs, FDA and ICH guidelines
• Represented Exelixis at industry meetings, and advisory board activities.
• Created and reviewed study protocols, informed consents, case report forms, study materials and monitoring tools.
• Assisted in the establishment of SOPs, and other working instructions and documents
Chiltern International, Inc., Austin, TX February 2006- July 2007
Regional Senior Clinical Research Associate
• Identified and assessed suitable centers for proposed studies
• Facilitated contracts and budgeting processes between Sponsor company and sites
• Prepared and reviewed documentation submission to regulatory authorities
• Participated in site initiation, clinical trials monitoring, and site close-out visits
• Responsible for electronic data collection and quality control review of data collected at trial sites to ensure compliance with protocols
• Assisted in-house project team with completion of study process documentation
• Trained new team members and attended Investigator Meetings
MedImmuune Oncology, Inc., Gaithersburg, MD February 2004 – October 2005
Senior Clinical Research Associate
• Responsibilities included collaborating, overseeing, and communicating with vendors, investigators, and internal team members to ensure successful conduct of clinical trials
• Oversaw the development of contracts and budgets with vendors and investigators
• Updated and reviewed clinical study budget
• Assisted with protocol and template informed consent development
• Coordinated activities involving study start up: case report form development, study drug supply design, and regulatory document filing
• Oversaw and/or performed pre-study, initiation, monitoring, and close-out visits to ensure good clinical practice compliance
• Worked with site staff and MedImmune Product Safety staff to ensure timely and correct reporting of serious adverse events and safety data
• Managed all aspects of study progress including adherence to timelines, enrollment, clinical supplies, data delivery, and payments
• Represented MedImmune at various industry and therapeutic meetings as well as assisting in the coordination of in-house therapeutic Advisory Board meetings.
Parexel International, Alexandria, VA May 1996 – February 2004
Primary/Lead Clinical Research Associate
• Responsibilities included preparation of study materials/tools, report review, tracking of client deliverables
• Communicated with the International project CRA team, Project Management, clinical investigators and other site personnel to ensure the quality and integrity of data and proper management of study parameters and budget
• Responsible for on-going client communication, mentoring and training team of CRAs/CRAssistants
Clinical Research Associate I/II, Senior Clinical Research Associate
• Responsibilities included preparation, review, and collection of regulatory documents
• Served as a liaison between Sponsor companies and investigative sites;
• Other duties included clinical trials monitoring, site evaluation and initiation, data collection and review
• Performed Investigational Product accountability at trial sites to ensure compliance with protocols
• Monitored sites and data to ensure compliance with FDA regulations, ICH guidelines, and local requirements
• Supervised and motivated a team of reimbursement hotline analysts handling 16 product lines for 7 pharmaceutical companies
• Served as a liaison between clients and PAREXEL
• Provided product-specific reimbursement training for client sales force
• Assisted in the production of monthly activity reports and budgets
• Assisted with recruitment and interviewing of potential employees
• Developed, organized, and conducted training program for analysts
• Developed Standard Operating Procedures for new and existing programs
• Assisted in the development of new program database
• Provided input on performance evaluations and conduct performance reviews.
Medical Marketing Services Reimbursement Analyst
• Responded to inquiries regarding pharmaceutical programs and products
• Researched individual cases and made recommendations to optimize provider reimbursement
• Reviewed and processed patient assistance applications, identifying alternative reimbursement resources
• Responsible for researching and reporting third-party payer policy changes
Home Health Equipment Company, Alexandria, VA August 1994 – May 1996
• Audited personal and corporate accounts, and administered corrective actions to ensure appropriate reimbursement
• Researched and processed inquiries and correspondence from third-party payers, patient representatives, and individual clients
Masters of Health Science, Health Policy & Management May 2001
The Johns Hopkins University, Bloomberg School of Public Health Baltimore, MD
Bachelor of Science, Health Policy & Administration, May 1994
The Pennsylvania State University University Park, PA
ACRP- Certified CRA
Therapeutic Areas include oncology, CNS, and endocrine/metabolism.
Experience in conducting pre-study through close-out visits.
Served as Lead CRA on several international studies.
Familiar with EDC and CTMS.
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