Senior Central Monitor from Joulé
San Rafael, CA 94903
About the Job
Job Title: Senior Central Monitor
Location remote
Hours/Schedule: Monday - Friday
Compensation: $35-40/hr
Overview
Joule is seeking a Senior Central Monitor to join a collaborative and innovative team for a 6-month contract. This role offers a unique opportunity to contribute to centralized monitoring and risk-based monitoring (RBM) activities in clinical trials. As a key member of the team, you will play a critical role in ensuring data quality, patient safety, and efficient trial execution while working closely with cross-functional teams to assess and mitigate risks. If you are detail-oriented, adept at managing data, and passionate about clinical research, this position is an excellent fit for you.
Responsibilities
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Develop and review study metrics, triggers, KRIs, and other monitoring tools to identify and mitigate risks in clinical trials.
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Collaborate with cross-functional teams to implement and review centralized monitoring outputs, ensuring data quality and patient safety.
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Set up and test study data integration with RBM systems to support key monitoring processes, including statistical analyses and root cause investigations.
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Communicate findings and monitoring observations to study teams, leading discussions and coordinating with appropriate partners.
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Ensure compliance with regulatory requirements (FDA, ICH, GCP) and align RBM implementation with data access plans.
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Demonstrate expertise in data management, statistical tools (SAS, R, Python), and clinical research processes, while managing multiple projects effectively.
Requirements
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Bachelor’s degree in life science, data science, statistics, or mathematics; Master’s degree preferred.
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Minimum of 5+ years of experience in data management or RBQM activities.
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Proficiency in statistical programming languages and Microsoft Office tools.
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Strong interpersonal and communication skills with the ability to work independently and collaboratively.
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Knowledge of clinical research and regulatory guidelines, including FDA, ICH, GCP, and GCDMP.
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Ability to manage priorities in a fast-paced environment and deliver high-quality results on time.