Sr Associate R&D QA - Compliance & GCP, Clinical Auditing

In this professional role you will be a member of the R&D Quality Assurance organization, reporting directly to the Director of R&D Quality Assurance. This individual will work with the senior director of clinical operations and other clinical staff to establish an annual plan for audits of clinical trials that satisfies the requirements as set forth by the clinical departments standard operating procedure for audits of investigator sites.  Will plan timing of audits and perform audits at clinical investigator sites which may include any or all parties participating in clinical research such as but not limited to the institutions pharmacy, laboratory, hospital charts of enrolled patients, drug storage facilities and documentation etc.  In addition, other audits of the Talecris internal clinical department (including master file documentation), and audits of external contract research organizations (including compliance oversight) used by Talecris Clinical Department in conducting or support of Talecris clinical research will be executed by the incumbent.



Will coordinate and direct the work of any contractors that are usedto conduct audits. This will include the development of audit plans, scope/work agreements and ensuring necessary controls are in place for these services suchthat they are performed under compliance with all regulatory, corporate, departmental and quality system requirements.


Evaluate audit findings and suitability of responses to audit reports.
Review clinical documents such a protocols, amendments, sample case report forms, informed consent forms for compliance to requirements as necessary.
Perform additional audit activities related to GLP functions within R&D as well as develop and execute audit functions for healthcare compliance related activities for the Scientific Relations and Scientific Communications areas of Medical Affaires. 
Train Talecris and/or investigational site staff on regulatory requirements and quality initiatives. 
Responsible for the overall compliance of Talecris clinical studies and medical affaires activities with state, national, international and corporate policy, regulations and guidelines. 
Independently conduct in-depth audits of clinical investigator site, CRO/vendor, and data/case report forms of clinical research studies to assure compliance with all applicable state, national/international regulations and guidelines, Company policy, SOPs, and industry standards.
Independently conduct in-depth audits of internal groups and clinical quality systems/processes for adherence to all applicable regulations /guidances, company policy, SOPs and industry standards.
Independently prepare and issue detailed audit reports to auditees, including investigators, study personnel, CROs/vendors, clinical management, liaisons, Clinical Operations and Medical Affaires management. Through development and execution of departmental SOP?s the incumbent will review all audit findings and responses to audit reports to assure that all responsesproposed by the auditees to any observations are acceptable and all observations have been adequately addressed.
Independently conduct audits of activities in the post-marketing areas of Scientific Relations and Scientific Affaires for compliance to Talecris healthcare policy compliance.  These areas include audits of files/records and processes related to Liaison activities, Continuing Medical Education (CME), grants and medical expert contacts.
In partnership with Performance Development will conduct GCP and healthcare compliance training for internal and/or external study personnel.  Will also provide an interface for management in GCP, GLP and healthcare compliance areas to PD regarding current training needs and future direction for staff development. 
Perform routine surveillance to maintain a risk-awareness to new regulatory and industry developments in GCP, GLP and healthcare compliance areas and advise the appropriate staff of trends or changes as they impact Talecris business and quality practices. 

 

This position requires a BS in the Life Sciences (preferably medically related) with a MINIMUM of 8 years relevant experience in a quality assurance, regulatory affairs, or clinical research/study coordination function. OR an MS degree with a minimum of 6 years relevant experience is required. A minimum of 3 years of GCP auditing experience is required.  Candidates must be well organized, detail-oriented, and have the capacity to be an effective team player. Strong verbal and written communication skills are necessary. A thorough understanding of FDA and EU regulations, regulatory guidelines, and standards for the investigation of new medical products is required. Training in scientific, quality, or compliance audit techniques is required.



Please visit our website at