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THE SENIOR CLINICAL RESEARCH ASSOCIATE

My client is the world’s leading developer of customized DNA-binding proteins for targeted gene regulation and genome engineering. They are applying this technology in diverse therapeutic areas including cardiovascular disease, diabetic neuropathy, neuropathic pain and HIV / AIDS. The company’s most advanced therapeutic compound, a designed zinc finger protein transcription factor that activates the VEGF-A gene, is in phase II testing for treatment of diabetic neuropathy. They also have active programs in crop engineering, the development of cell lines for biologics production, and the construction of animal models of human disease.

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Essential Functions

Essential functions include, but are not limited to the following:

 Assist in the design, planning and implementation of clinical research projects
 Manage the development of protocols, Investigator Brochures, case report forms, informed consents, study manuals and study budgets
 Negotiate and finalize site contracts and budgets, manage and calculate site payments
 Perform site visits including site qualification, initiation, monitoring and close-out visits; co-monitor with regional monitors and review monitoring reports
 Ensure adherence to the protocol providing for accurate data collection, documenting drug accountability and compliance with federal regulations
 Represent the company in a professional manner; establish and maintain good relationships with investigators and study site personnel
 Maintain frequent site contact; prepare and track required documentation and manage study supplies at clinical sites
 Oversee and track project progress at assigned sites (patient status, safety/adverse events, CRF completion, payments, study drug supply, regulatory documents)
 Review data listings on an ongoing basis
 Assist in planning Investigator Meetings
 Assist in preparing interim study analyses, annual reports, and clinical study reports
 Manage external vendors, develop study specifications, and finalize vendor contracts; vendors may include and are not limited to Contract Research Organizations (CROs), central laboratories, interactive voice response service for randomization (IVRS)

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Additional Details:

 Salary Range: $83K - $93K
 Preference given to strong experience in pharmaceutical clinical trials
 Device clinical trial experience does not qualify
 CRO site monitoring experience alone does not qualify
 Experience as Clinical Trial Associate would have to match all requirements
 Shave strong experience in the initiation, management, and close-out of pharmaceutical clinical trials
 Position reports to VP of Clinical Affairs

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 4 to 5 years of Pharmaceutical industry experience including direct site management
 BA/BS degree in nursing, pharmacy, life sciences or health-related discipline
 Thorough knowledge of GCP, ICH and FDA regulations
 Strong organizational skills, detail oriented, and able to multi-task and work effectively in a fast-paced environment
 Self-motivated, assertive and able to function independently or as part of a team
 Strong written and verbal communication; strong interpersonal skills
 Ability to work on company site and to travel 30-40%