Senior Lead Clinical Research Associate - Biotech Resume Search
Senior Lead Clinical Research Associate - Biotech Resume Search
My Spider Scam Awareness Contacting Us F. A. Q.
 
Job Seekers
Search Jobs
Browse Jobs
Post a Resume
Job Alerts
 
Employers
Search Resumes
Browse Resumes
Post a Job

Senior/Lead Clinical Research Associate Resume


Desired Industry: Biotech SpiderID: 23478
Desired Job Location: Washington, District of Columbia Date Posted: 11/20/2008
Type of Position: Full-Time Permanent Availability Date: ASAP
Desired Wage:
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


Objective:
Looking for a Senior/Lead CRA position, preferably home-based.


Experience:
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

Associate Manager

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
Claims Auditor

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


Education:
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


Affiliations:
ACRP- Certified CRA


Skills:
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.


Candidate Contact Information:
JobSpider.com has chosen not to make contact information available on this page.
Click "Contact Candidate" to send this candidate a response.


    





© 2020 Job Spider
Privacy Policy | CC Marketing Sites | Site Map | Links