Clinical Advisor

3 weeks ago

Rockville, United States RJ IT Solutions Full time

RJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/project management. Our commitment to excellence has made us a trusted partner of top research organizations, including multiple institutes at the National Institutes of Health (NIH). At RJIT Solutions, we combine the agility of a small business with the comprehensive capabilities of a large organization to accelerate research and enhance decision-making processes in healthcare and research sectors. As part of our unrelenting focus on quality and compliance, RJIT Solutions delivery is based on Certified Matured Processes including CMMI L3 SVC, ISO 20000, ISO 27001, and ISO 9001 quality processes.

Technical Requirements: Clinical Advisor

Provide project management of day-to-day DAIDS TMF activities including but not limited to coordinating and leading meetings, and discussions regarding all aspects of trial master files.

Serve as the primary reviewer of TMF deliverables including but not limited to standard TMF reports, TMF messages, and TMF documents in electronic systems.

Manage and design TMF related trainings for DAIDS and collaborators and present proposals/materials to the federal client for approval prior to implementation.

Coordinate and communicate to provide support and guidance to various functional areas supporting DAIDSTMFs.

Provide support of DAIDS TMF operations during TMF implementation, audits, and/or regulatory inspections.

Ensure TMFs are inspection ready at all times and TMF documents are filed contemporaneously.

Monitor and identify trends, communicate issues, and recommend policy and procedural changes to improve operations to the federal client prior to implementation.

Represent DAIDS on working groups and committees to communicate information regarding TMF policies, procedures, and requirements.

Provide guidance, consultation and expert advice on regulations, policies and procedures to DAIDS staff and collaborators.

Establish quality assurance standards and metrics for TMF policies and procedures.

Ensure DAIDS compliance with all regulations, policies and procedures related TMFs.

Participate in working groups and team meetings, as required.

Develop SOPs as required to ensure oversight of the DAIDS TMF process.

Other Requirements:

Telework may be authorized if approved by the Task Leader, COR, and the Contracting Officer.

Specific Qualifications:

MS degree is required.

Minimum of 3-5 years of TMF specific experience is required.

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