| Job details | |
| Job industry : | Biotechnology/Pharmaceutical |
| Job segment : | Education/Research |
| Job role : | Analyst |
| Job skill : | Informatica + Pharma exp needed- HOT HOT HOT |
| Position vacant : | 4465 - Sr. Clinical Quality Specialist |
| Job location : | Rochester, New York |
| Job details | |
| Company name : | Barron/Carlington Group |
| Minimum experience : | 3 years |
| Maximum experience : | 7 years |
| Job type : | Permanent |
| Gross pay : | 88000 Yearly |
| Job posted : | Jul 22, 2008 |
| Job description | |
| Job description: | POSITION DETAILS
Salary Range: $70K - 95K US Citizen or Permanent Resident [Green Card Holder] only Best Industry- Healthcare Department : Quality Assurance , Research & Development 4 Year Degree 3- 5-years exp Up to 25% Travel Relocation Available - moving allowance of one (1) month’s salary. Job Duties: Support the Global Clinical Programs Clinical Quality and Document Control function with a primary responsibility for conducting internal and external audits. Conduct external and internal comprehensive audits and document reviews independently and effectively in compliance with department SOPs. During audits, gather information and evaluate processes against applicable regulations (FDA, HIPAA, etc.), SOPs and policies, company business needs and other applicable standards. Distinguish between relevant and irrelevant facts to provide accurate and timely audit reports with recommendations for resolution; follow all major and critical findings to completion of resolution. Support department training and SOP development needs. Support department management when hosting FDA inspections. Special Skills: Expert organizational, written and verbal communication skills and the ability to present with a professional and diplomatic approach are required for this role. Specialized Training: Extensive knowledge of GCP regulations/guidelines and Privacy regulations worldwide, as they pertain to clinical research and a good understanding of drug and device clinical trial development processes and clinical monitoring practices. Candidate Must Have: Bachelor’s degree preferably in biological or medical sciences Five years experience in a compliance, regulatory or clinical environment, preferably with at least 2 years Good Clinical Practices audit experience. |
| How to apply : | Register to view |
| Third party mediation allowed : | No |
| Telecommute : | No |
| This job is expired. | ||||
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