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About our client
Our client is a leading global health-care supplier and the world’s largest manufacturer of over-the-counter (OTC) pharmaceutical and nutritional products for the store-brand market. The company also develops and manufactures generic prescription (Rx) drugs, active pharmaceutical ingredients (API), and consumer products.
Position	Location
Clinical Compliance Associate	New York
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Assess quality systems / scientific reports and clinical data 2) Conduct external audits of clinical investigator sites, contract research organizations, and vendors 3) Generate audit reports and render quality assurance presentations to affiliates, clinical investigators, and R&D personnel 4) Coordinate, collect, and distribute regulatory documents for the initiation of clinical studies as well as maintenance of those documents 5) Assist the Director and Project Managers with tracking of training and compliance documents in accordance with FDA requirements 6) Maintain a database of audit findings, qualifying investigator sites and vendors, and implement a grading system 7) Serve as Study File Manager 8) Reconcile study drug returns for compliance assessment and initiate destruction processes 9) Review periodic monitoring reports for ongoing clinical trials 10) Follow up on corrective and preventive actions to ensure continued efficacy 11) Support generation of submission reports to the FDA 12) Assist in the distribution of IND safety letters 13) Oversee maintenance of retention samples at sites as well as the company 14) Track training and compliance documents for all staff 15) Review and provide feedback on clinical study reports 16) Maintain department SOPs and assess compliance periodically 17) Assist in developing SOPs to ensure regulatory compliance 18) Work closely with Pharmacovigilance group and regulatory bodies to monitor AEs / SAEs and report to the FDA 19) Maintain Pharmacovigilance data in a database
Requirements
1) BS degree in a Physical or Life Sciences, Nursing, or Pharmacy, or equivalent experience in lieu of a degree 2) Certification preferred 3) 3-5 years’ pharmaceutical clinical research and/or quality assurance monitoring experience 4) Auditing training/experience (e.g. RAB or similar type training and/or extensive auditing experience in a cGMP environment) 5) Familiarity with current and pending FDA Regulations, 21CFR, and ICH Guidelines 6) Knowledge of cGMPs, GCPs and SOPs 7) Familiarity with HIPAA requirements 8) Thorough understanding of clinical practices 9) Good communication, analytical, and organizational skills with attention to details 10) Ability to prioritize, multi-task, and work with minimal supervision 11) Strong computer knowledge 12) Willingness to travel - Up to 50% (both national and international)