Clinical Research Quality Assurance Specialist

Revival Research Institute is a growing Clinical Research Organization. This dynamic group is growing all over US, with offices in over 6 States and exceptional Clinical research and support team. The Clinical Research Quality Assurance Specialist ensures the integrity and quality of clinical trials are maintained and conducted in accordance w/ federal, state, and local regulations, Institutional Review Board (IRB) approvals, and other policies, and procedures. This position is primarily responsible for the accurate completion data entry for study patients according to protocols, and for protecting the integrity of Research data.

Representative Responsibilities:

· Data and Documentation of clinical trials visits

· Manage the QA team of 7 individuals working oversees for Quality Assurance of all Clinical Research sites

· Review and analyze clinical trial data and related documentation (internal and external). Provide guidance to clinical faculty and staff in clinical research documentation clinical trials. Develop monitoring plans with indicators of quality, reliability, and adherence to SOPs. Develop and communicate outcome measures.

· Monitoring the development of Electronic Source documents along with template for study procedures

· Develop comprehensive data safety monitoring plans for all clinical trial activities within the assigned department to ensure that trials are conducted in compliance with the protocol, SOPs, ICH GCP, federal, state, and local regulatory requirements.

· Prepare and execute monitoring plans both internally and at affiliate sites, including site visits to ensure protocol and regulatory compliance; data management tasks to ensure study data integrity; verify essential documents are accurate, complete, and maintained; and coordination of applicable follow-up activities. Assist in the development and implementation of action plans for external monitoring/audit follow-up. Assist in preparation and conduct of audits/surveys/inspections by FDA, DHHS, institutional, and accreditation agencies. Develop improvement plans using quality improvement methods (process improvement, continuous improvement, total quality management, etc.).

· Protocols Provide input into the development of new protocols and plans for implementing new trials as requested by Principal Investigators/Managers. Participate in the development of investigator-led protocols, e.g., data safety monitoring plans. Develop and maintain SOPs for clinical trials. Act as a primary resource on an ongoing basis for clinical trials staff, responding to questions and issues pertaining to study documentation, GCP, or other issues as requested.

· Training Assist in developing and providing clinical trial training and consultation for faculty, staff, and affiliate sites. Provide training (ICH GCP, FDA, DHHS, state, local, and institutional) and/or other training initiatives to faculty and staff, as assigned.