Clinical Trial Analyst

Key Role:

Perform quality assurance and quality control reviews for clinical trial results submissions for consistency with review criteria and guidelines. Communicate with study sponsors and data providers to assist with clinical trial results submissions and adherence to submission requirements. Provide training, guidance, and assistance to staff, researchers, and reviewers on querying results and best practices for obtaining clinical trial information. Lead and contribute to various projects related to collection and dissemination of clinical trial information

Basic Qualifications:

-2+ of experience with clinical trial submissions

-Experience with CDISC study data standards for clinical trial results submission, protocol documentation, and protocol reviews

-Knowledge of the requirements of the US Public Law 110-85 (FDAAA), US Public Law FDAAA 801, and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11)

-Knowledge of CDISC study data standards for clinical trial results submission

-Ability to obtain a security clearance

-BA or BS degree

Additional Qualifications:

-Knowledge of MeSH standards

-Possession of excellent oral and written communication skills

-PhD degree in a life sciences-related field

Clearance:

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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