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Senior Clinical Research Associate

Posted By:
Kate Higgins
Posting ID:
Mountain View, Ca
Category:Biotech / Science
Listing Type:Job
Employment:Full Time
Company:VIVUS, Inc.

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VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. Analysts speculate that the potential market for obesity ranges from $5 billion to $10 billion annually, and the indications targeted by VIVUS' sexual health products each represent a projected market greater than $1 billion annually. We currently have openings for a Senior Clinical Research Associate in our corporate headquarters in Mountain View, CA.

The Senior Clinical Research Associate will participate in the development, conduct and reporting of ongoing clinical trials in accordance with GCP requirements.


- Performs Pre-Study Site Inspections, Study
Initiation Visits, Interim Study Visits, Study
Termination Visits independently.
- Coordinates the in-house start-up of clinical
- Writes protocols under supervision of Senior
Manager or Director of Clinical.
- Ensures all regulatory issues are met prior to site
initiation (IRB approvals, contracts, 1572s, CVs).
- Facilitates contract negotiations.
- Assists in planning of data analysis.
- Independently manages one or more concurrently
ongoing clinical studies, including coordination of
contract personnel, in-house monitoring,
manufacturing for drug availability and the close
out of clinical studies.
- Performs routine monitoring visits.
- Writes and reviews Clinical Standard Operating
Procedures (SOPs).
- Assists in annual IND updates, annual revisions of
Investigator Brochures and with preparation of final
study reports and publications.
- Organizes presentations for professional meetings
hosted by VIVUS.
- Reviews quarterly payments for investigators.


- 3 to 8 years clinical trials experience in
pharmaceutical industry, particularly with drugs.
- BA/BS/ in life or bioscience required, MS highly
- Excellent written and interpersonal skills needed.
- Travel up to 20%.

Please submit your resume, with salary history and salary requirements.

Only candidates meeting this criteria will be considered.


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