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US-WA-Seattle: Clinical Research Associate in biotech
To see other BioTech job opportunities,
please visit http://biotech.fyicenter.com/
Date: 24-Jun-2008
Clinical Research Associate in biotech
1. Interact directly with clinical sites, including clinical investigators and other health care professionals involved in the clinical study, and maintain a positive rapport with each site.
2. Attend procedures to support sites (e.g. provide guidance in case report form [CRF] completion) and obtain product development feedback.
3. Monitor clinical study data at sites to ensure regulatory and protocol compliance.
4. Conduct other site visits (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim site visits, and study close-out visits), as required.
5. Generate clear and concise trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc) and, as required, clinical summaries.
6. Manage product inventories for clinical studies.
7. Maintain study documentation (e.g., correspondence, CRFs, deviations, budget information).
8. Ensure clinical studies are conducted in a timely manner and within site budgets.
9. Assist in generation of protocols, CRFs, Informed Consent documents, Instructions for Use, Operator's Manuals, and site training materials development for pre- and post-market studies.
10. Assist with CRF generation and report preparation as needed.
11. Prepare reports in support of external physician advisory committees.
12. Assist in preparation of reports for submission to regulatory agencies.
13. Assist with preclinical studies (i.e., phantom testing and animal testing)
14. Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and IDE) associated with preclinical and clinical studies.
SECONDARY RESPONSIBILITIES:
1. Assist in the analysis of clinical and research data.
2. Enter data into and maintain study related tracking database(s).
3. Participate in the design and submission of regulatory documents
4. Assist in the creation and editing of clinical transcripts
5. Follow all company safety policies and procedures while ensuring quality work.
6. Handle changing priorities and other duties as required.
MINIMUM REQUIREMENTS
1. Bachelor's degree or equivalent.
2. 1 year minimum experience in clinical monitoring and related experience as a CRA or clinical coordinator or 2 years experience in radiation therapy.
3. Experience with clinical studies and data collection
4. Ability to travel in support of the clinical and preclinical activities
SKILLS, ABILITIES AND OTHER REQUIREMENTS
1. Proficient in FDA regulations for clinical studies and medical devices, including GCPs and IDE regulations.
2. Working knowledge of medical terminology.
3. Excellent knowledge of MS Word and good knowledge of MS Excel.
4. Strong project management, documentation, and organizational skills; detail and accuracy oriented.
5. Strong verbal communication skills and effective writing skills.
6. Successful history in a team-oriented environment yet able to work independently.
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
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