Clinical Trials Monitor
About The Position
The Clinical Trials Monitor monitors and audits investigator-initiated clinical research studies across disease groups in the Cancer Clinical Trials Office. The role also supports audit preparation by reviewing records for potential FDA or sponsor audits and may contribute to quality improvement and policy activities. The position is primarily remote, with some on-site work potentially required. The monitor supports research quality and regulatory compliance through study and facility monitoring, detailed study reviews, audits, documentation management, staff training, inspection readiness, and review of clinical trial and non-human primate data. The role also assists with laboratory administration and regulatory filings, and manages laboratory communications and web content in accordance with institutional guidelines.
Requirements
- Bachelor's degree in Life Sciences or a related field.
- 1–3 years of related work experience in clinical trials and/or regulatory work.
- Solid understanding of FDA good clinical practice guidelines.
- Ability to maintain confidential and sensitive information, set priorities, and work independently and collaboratively with research and hospital personnel.
- Positive, professional, and collaborative attitude, with organization, time-management, and critical-thinking skills.
- Advanced skills with Microsoft applications, which may include Outlook, Word, Excel, PowerPoint, or Access, and other web-based applications; ability to produce complex documents, perform analysis, and maintain databases.
- Competence in ICH E6 (GCP/GLP/GCLP), ICH Q9, 21 CFR, GDPR, and HIPAA laws and regulations.
- Ability to make decisions guided by general instructions and practices, interpret situations, and recommend solutions to problems of moderate complexity and importance.
- Ability to analyze varied problems using observation, knowledge, skills, and general precedents.
- Ability to follow precedents and procedures, prioritize and organize work within general guidelines, and seek assistance in difficult or unpredictable situations.
- Clear and effective written communication in English with internal and external customers.
- Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families, and external customers.
- Working knowledge of standard concepts, practices, procedures, and policies, with the ability to apply them in varied situations.
- Ability to lead small projects or work groups, foster a collaborative and respectful team environment, and improve workflows.
- Ability to provide professional, respectful, service-oriented customer service and remain calm in stressful situations.
Nice To Haves
- Master's degree in Life Sciences or a related field.
Responsibilities
- Monitor study facilities to assure compliance with GCLP and ICH guidelines.
- Conduct detailed reviews of clinical studies in collaboration with pharmaceutical companies and other sponsors.
- Audit study facilities, including equipment, documents, and procedures, to ensure regulatory compliance.
- Manage Corrective Action Logs, Deviation Trending Logs, SOPs, GCLP documents, and personnel performance for accurate risk assessment; recommend and oversee improvements to research quality and efficiency.
- Help prepare the study facility for inspections through collaboration across teams and departments, and ensure GCP/GCLP staff in designated areas are adequately trained according to regulatory and SOP standards.
- Collaborate with the document control team on the development, implementation, and maintenance of SOPs, study protocols, and supporting documents.
- Review clinical trial and non-human primate data for integrity, privacy, consistency, and compliance across multiple trials.
- Assist with day-to-day laboratory administration, including calendar management, ordering, event planning, and other administrative functions as needed.
- Assist with laboratory regulatory filings, including shipping permits and adding personnel to IACUC animal protocols.
- Manage the laboratory's social media and center website according to institutional guidelines, including creating content and updating news, publications, staff profiles, and information about activities and events.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
