Clinical Trials Scientific Review And Monitoring Coordinator

Job Title:

Clinical Trials Scientific Review and Monitoring Coordinator

Job Description

This role supports high-impact oncology clinical research by coordinating scientific review and ongoing monitoring of clinical trials to ensure regulatory compliance, data integrity, and protection of human subjects. The Clinical Trials Scientific Review and Monitoring Coordinator works as part of a respected cancer research program, serving as a key liaison between investigators, scientific review bodies, and oversight committees. The position involves detailed review of clinical trial protocols and data, oversight of compliance with applicable regulations and Good Clinical Practice (GCP), and participation in study audits and monitoring activities in a fast-paced, intellectually stimulating environment.

Responsibilities

+ Coordinate and support scientific review and monitoring activities for oncology clinical trials in accordance with institutional policies and applicable regulations.

+ Conduct detailed reviews of clinical trial protocols, informed consent documents, and related study materials to ensure scientific rigor, regulatory compliance, and protection of human subjects.

+ Participate in and support internal and external study audits, including on-site and remote audits, to assess adherence to Good Clinical Practice (GCP), institutional requirements, and sponsor expectations.

+ Monitor clinical trial conduct and documentation, including data quality, chart reviews, and adherence to protocol requirements, and identify potential issues or deviations.

+ Collaborate closely with investigators, study coordinators, data management teams, and other stakeholders to resolve compliance issues and improve study processes.

+ Interface with Institutional Review Boards (IRBs) and scientific review committees, assisting with submissions, responses to queries, and ongoing reporting as needed.

+ Support clinical data management activities, including review of data in electronic data capture (EDC) systems and other clinical data platforms to ensure accuracy and completeness.

+ Apply strong analytical and critical thinking skills to evaluate complex clinical research information and provide clear, actionable feedback to study teams.

+ Manage multiple projects simultaneously, prioritize tasks, and meet time-sensitive deadlines in a fast-paced environment with competing priorities.

+ Maintain thorough and organized documentation of monitoring activities, findings, and follow-up actions in accordance with institutional and regulatory standards.

+ Contribute to the development and refinement of operational procedures and best practices that support exceptional compliance and operational excellence in clinical research.

+ Build and maintain positive working relationships at all levels of the institution, fostering a collaborative and supportive team environment.

+ Demonstrate a strong customer service attitude when interacting with investigators, staff, and external partners, providing clear guidance and support.

+ Use advanced computer software tools to manage data, track activities, prepare reports, and support the overall scientific review and monitoring process.

Essential Skills

+ Minimum of a BA/BS in a relevant discipline, with a focus on biological sciences required.

+ 2-3 years of experience and knowledge directly related to clinical research.

+ Detailed knowledge of applicable regulations related to clinical research, including human subjects protections and Good Clinical Practice (GCP).

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Experience with Institutional Review Board (IRB) processes and/or scientific review of clinical research.

+ Hands-on experience in clinical research operations, including clinical trials, monitoring, and auditing.

+ Experience working with oncology clinical research and oncology clinical trials.

+ Proficiency in clinical data management, including use of electronic data capture (EDC) systems and clinical data platforms.

+ Demonstrated project and time management skills, with the ability to manage multiple studies and deadlines concurrently.

+ Ability to work independently with minimal supervision while contributing effectively to a team…