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Clinical Trials Data Quality Analyst

Black Canyon ConsultingBethesda, Maryland
On-site Full-time $65K/yr - $70K/yr

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Experience Level

Entry Level

Qualifications

Duties & Responsibilities:Conduct thorough quality assurance and quality control (QA/QC) assessments of clinical trial registration submissions to ensure adherence to review criteria. Develop a comprehensive understanding of ClinicalTrials.gov Protocol Data Element Definitions (https://clinicaltrials.gov/policy/protocol-definitions) and registration review criteria (https://clinicaltrials.gov/submit-studies/prs-help/protocol-registration-quality-control-review-criteria). Communicate effectively via email and record reviews with responsible parties (e.g., clinical trial sponsors and principal investigators) regarding the conformity of clinical trial records. Perform meticulous proofreading tasks.

About the job

Black Canyon Consulting (BCC) is actively seeking a Clinical Trials Data Quality Analyst to enhance the integrity of data submitted to ClinicalTrials.gov, a critical registry operated by the National Library of Medicine (NLM) under the National Institutes of Health (NIH). ClinicalTrials.gov serves as a vital database for both publicly and privately supported clinical research conducted globally. The submission process is managed through the Protocol Registration and Results System (PRS), where responsible parties register their trials and submit results ahead of journal publication. Unlike peer-reviewed articles, data posted to ClinicalTrials.gov undergo specific review criteria to ensure accuracy.

The ideal candidate will be tasked with reviewing submitted results data to verify compliance with the established review criteria for ClinicalTrials.gov postings. For more details about the ClinicalTrials.gov database and reporting requirements, please visit https://clinicaltrials.gov/policy/fdaaa-801-final-rule.

About Black Canyon Consulting

At Black Canyon Consulting, we are dedicated to advancing clinical research by ensuring data quality and compliance with regulatory standards. We pride ourselves on fostering a collaborative and supportive work environment that empowers our employees to excel in their roles.

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