| Senior Regulatory Compliance Auditor -- Durham, NC |
Author: Yvonne Higgins
Date: 06-14-11 13:29
Senior Regulatory Compliance Auditor
Copernicus Group IRB
Durham, North Carolina
– Work closely with Manager, Quality Assurance & Regulatory Compliance in revising/improving internal policies and procedures as they relate to quality assurance/compliance needs.
– Assist in the development, implementation, and the administration of corporate quality and compliance systems ensuring the operations of the company are in compliance with applicable regulations and corporate requirements and expectations.
– Schedule, conduct, and provide timely reports of:
o Noncompliance investigations of principal investigators
o Vendor audits/assessments and internal systems/process audits to assure compliance with SOPs and applicable regulations and guidelines
o Routine and board-directed site visits of domestic clinical investigators approved by CGIRB, as directed
– Schedule and prepare for client visits and provide auditors with requested information while preserving the sensitive confidential information of the organization.
– Effectively communicate actionable findings to various staff levels. Effectively present findings to ensure clear understanding of deficiencies (verbal and written).
– Assist in the design and implementation of standard operating procedures (SOPs) related to auditing. Serve as a reviewer for other SOPs containing procedures related to quality assurance and regulatory compliance.
– Attend project meetings and special topic committees as QA/RC consultant to obtain status information and develop and propose project-specific audit plans and timelines.
– Provide consultative services to all CGIRB support staff regarding compliance issues and provide proactive recommendations/suggestions to insure adherence to FDA regulations and guidelines.
– Plan and deliver the training of new hires, existing staff and clients as needed/contracted
Qualifications:
Bachelor degree or an equivalent combination of education and clinical research or quality assurance experience. At least 4 years of experience working in clinical research or the pharmaceutical industry is required.
Experience in assessing regulatory compliance of IRBs is preferable; however at least 2 years of QA auditing is required. A practical knowledge of federal regulations concerning Good Clinical Practice (GCP), 21 CFR Parts 50, 56, 312, 45CFR Part 46, 160 & 164 and FDA, OHRP, and ICH, GCP guidelines is required.
Certification as a CQA, RQAP-GCP/RQAP-GLP, or RAC is desirable. Must be prepared to sit Institutional Review Board (IRB) examination within 24 months of hire. Must be conversant with quality sciences (Quality Assurance (QA) and Quality Control (QC)), and applicable regulations, validation strategy, and industry standards governing clinical research.
Qualified candidates must possess excellent verbal and written communication and presentation skills, and have intermediate to advanced skills in Microsoft Word, Excel, Outlook, Access, and PowerPoint. Ideal candidates have the ability to multi-task, work in demanding situations, meet strict deadlines, and work independently.
Strong interpersonal skills required. Candidates must be prepared to travel up to 25%. In most instances some advanced notice is provided; however, flexibility to travel on fairly short notice is also required.
If you meet the requirements listed and are seeking an opportunity, please send your cover letter, resume and salary expectations, to HR at hr@cgirb.com or via fax at 919-465-4308. If CGIRB sees a match between your qualifications and current hiring needs, we will contact you.
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Author |
Date |
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Senior Regulatory Compliance Auditor -- Durham, NC |
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Yvonne Higgins |
06-14-11 13:29 |
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