Clinical Compliance Auditor

Title Clinical Compliance Auditor  Description Ikaria seeks a highly qualified Clinical Compliance Auditor for our corporate headquarters in Clinton, NJ. The Clinical Compliance Auditor will assist in the overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations by conducting audits of internal files, clinical sites, and vendors used to support clinical trials. The Auditor will support GCP monitoring and compliance for the organization by ensuring quality activities are performed and documented in compliance with Standard Operating Procedures, company guidelines, and applicable regulations. Scope of Responsibilities - Up to 50% travel, both domestic and international - Coordinate and conduct Clinical Site Audits in accordance with company SOPs and GCP regulations - Coordinate and conduct vendor and potential business partner audits - Conduct Trial Master File, Process and System audits to verify compliance with regulations, SOPs and guidelines - Develop audit plans and provide reports for various internal and external audits, assuring development and tracking of appropriate corrective action plans, as needed - Follow-up with individual departments on audit findings and corrective action plans - Attend project meetings as compliance representative and assist as a Quality/Compliance advisor - Provide oversight, guidance and training on regulations and compliance - Assist Manager with departmental activities as required and may act as Manager back-up - Willingness to cross train into cGMP to assist in support of GMP audits as needed

Please refer to job code ikaria-407526 when responding to this ad.

Category:	Accounting/Banking/Finance/Insurance
	> Auditing      > Other Banking
Location:	Clinton, NJ
County:	Hunterdon County
ZIP Code:	08809
Pay Rate:	Open
Job Terms:	full time
Company:	IKARIA
Phone:	email only please
Fax:	email only please