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Summary of job:
Assure a high level of quality in global clinical research projects, as defined in Federal Regulations, local regulations, GCP, company policies and applicable industry standards.
Support the outsourcing of Clinical Investigator Site Audits
Conduct Trial Master File Audits, Clinical Study Report audits and Internal Process Audits
Assist with health authority inspection preparation and facilitation
Conduct peer reviews of audit reports
Act as a scribe during meetings and author meeting minutes
Conducting peer reviews of audit reports
Providing GCP guidance to external customers
Risk assessments of audit observations and audit observation responses
Bachelor?s degree in associated functional discipline, advanced degree preferred
Clinical Quality Assurance experience
Fundamental knowledge of US, EU and International regulatory standards and guidelines for the conduct of clinical trials
Technical and administrative capabilities to carry out routine audits with minimal supervision or to play a supporting role in more complex audits
Must be analytical and thorough in work habits and report writing
Must have mature and professional communications skills, strong independent time management skills and the ability to multi-task
*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role*?
Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascents fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.
If you are ready to propel your career to new heights read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.