Quality Assurance Associate - GCP
Idenix Pharmaceuticals, Inc. - Cambridge, Massachusetts
The Quality Assurance Associate - GCP reviews and assesses systems supporting all clinical research associated activities for Idenix by conducting internal and external compliance audits. Under the supervision of QA Management, identifies risks, makes recommendations for systems/process upgrades, and implements systems/process changes as required. Consults with Clinical Research and acts as GCP resource to ensure compliance with applicable guidelines and regulations.
Principal Duties and Responsibilities:
* Conducts external clinical trial site and clinical vendor audits, both foreign and domestic, to ensure studies were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and applicable regional and local regulatory requirements.
* Conducts internal compliance audits to ensure compliance with policies and procedures.
* Issues detailed written audit reports, tracks and reviews all audit responses for complete corrective and preventative actions.
* Contributes to the preparation and revision of standard operating procedures related to clinical research.
* Provides GCP training as needed.
* Works directly with outside vendors in support of Clinical Operations.
* Supports regulatory inspection readiness for all GCP related areas.
* Works on other GCP/GLP projects under the guidance of QA Management.
Requirements:
Requires a Bachelor's degree in a scientific discipline or equivalent with a minimum of 2-4 years clinical research experience, and a minimum of 2 years of GCP Auditing or Clinical Research Monitoring experience.
* Working knowledge of GCP, ICH, EU Directives, FDA guidelines and regulations. GLP knowledge and 21 CFR Part 11 compliance is a plus.
* Computer literate: MS Office, including Word, Excel and Access skills are required.
* Ability to travel. This position will require up to 30-40% international and US travel.
* Experience in both internal and external compliance audits, including clinical trial sites
* Ability to independently plan and lead audits for multiple projects with minimum supervision.
* Ability to independently conduct a root-cause investigation and provide recommendations for resolution.
* Demonstrated organizational skills, as well as written and verbal communication skills.
Idenix offers an excellent benefits package including competitive salary, equity compensation, major medical insurance, dental insurance, 401(k) plan participation, and group life and disability insurance.
To be considered for this position, please send your resume by email or by mail to: Human Resources Idenix Pharmaceuticals 60 Hampshire Street Cambridge, MA 02139
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus