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The Alzheimer's Disease Cooperative Study (ADCS) is a multi-center clinical trials consortium created to provide an operational framework for large scale Alzheimer's disease research projects. The ADCS is a growing, progressive, multi-tiered organization which coordinates and manages approximately 10-15 different multi-center clinical trials at over 145 sites with federal and private grant and contract support. The type of studies that are managed by the ADCS range from Phase I through Phase III under IND(s) or IND- exemptions. The studies under IND are held to FDA standards and are held to regulatory scrutiny. The Regulatory Affairs Specialist is responsible to ensure compliance with FDA regulations and therefore will have a minimum of 5 years proven experience providing support in an FDA-regulated environment.
The Regulatory Affairs Specialist (RAS) works under the general supervision of the Regulatory Affairs Manager. The Alzheimer's Disease Cooperative Study conducts multiple clinical trials related to Alzheimer's Disease involving more than 2000 subjects. Clinical Research is conducted at multiple consortium member sites located at major educational institutions throughout the US plus additional contracted sites. At participating sites each protocol has a study coordinator who is responsible for organizing and implementing the protocol. The Regulatory Affairs Specialist (RAS) resides at the ADCS and the functions are divided into three phases throughout the duration of the study; protocol implementation, maintenance and study close out.
This position is responsible for developing documents required for study start-up activities, implementing tracking aides, as well as on-going monitoring strategies to ensure regulatory compliance. The RAS authors the initial regulatory essential documents templates required for each clinical site's IRB applications and follows through until FDA/NIH/IRB approvals are granted. Incumbent interacts routinely with the University of California San Diego departments and officials involved in clinical research oversight, the NIH, FDA, OHRP, and other regulatory entities responsible for human subject protections and Good Clinical Practices (GCP). Duties include the application and use of medical terminology and scientific/biological procedures, implementation of Good Clinical Practices (GCP), Good Document Practices (GDP), federal research regulations requirements, clinical trials administration and regulatory monitoring.
The incumbent will create subject informed consent forms, review and analyze proposed informed consent documents for consortium participating sites; provide support in the development, review and distribution of study set-up materials including, but not limited to, subject consent forms, clinical study protocols and regulatory packages; distribute final protocols and subsequent protocol amendments. In addition to supporting UCSD's ADCS IRB submissions and renewals, incumbent will interface and serve as a liaison with all participating ADCS clinicians, study coordinators, and IRBs to ensure protocol approval and will provide frequent reports to management on the status of clinical investigator documentation.
The Regulatory Affairs Specialist will play an active role in IND or IND-Exemptions determinations, interacting with the FDA project managers to determine type of submissions. The ADCS IND sponsor-investigator-initiated trials (IIT) will be submitted to the FDA by the Regulatory Affairs Specialist. The regulatory submissions will be maintained and filed electronically to FDA. In QA GCP and FDA audits, the Regulatory Affairs Specialist will play an active role, ensuring regulatory compliance, facilitating the audit and responding to questions or clarifications that may arise during the audit (s).
Theoretical knowledge of medical and pharmaceutical terminology and concepts, and/or biological science, with a Bachelor's Degree in pharmacy, biology or hematology, sufficient to prepare, review and understand the contents of medical research protocols and amendments; or an equivalent combination of education and experience.
Proven project management experience with the ability to successfully plan, organize, prioritize, develop, analyze, implement and manage multiple clinical research projects with complex logistics involving multi-sites and priorities.
Working knowledge of FDA regulations, OPRP, HRPP policies and procedures, and HIPAA. Familiarity with t
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