Clinical Trials Monitor

Job Description

The Clinical Trials Monitor (CTM) monitors and audits the investigator-initiated clinical research studies across all disease groups in the Cancer Clinical Trials Office. The CTM will also help with audit prep by reviewing records for potential FDA or sponsor audits and may be involved in quality improvement and policy.

Essential Responsibilities

• Maintains compliance with GCLP and ICH guidelines during study facility monitoring.
• Collaborates with pharmaceutical companies and other sponsors for detailed study reviews.
• Audits study facilities, including equipment, documents, and procedures, to ensure regulatory compliance.
• Ensures study facility inspection preparedness by collaborating across teams and departments.
• Develops, implements, and maintains SOPs, study protocols, and supporting documents.
• Ensures integrity, privacy, consistency, and compliance of clinical trial and non-human primate data for multiple trials.
• Supports lab administration in day-to-day functions such as calendar management, ordering, event planning, and regulatory filings.
• Engages externally and internally by managing the lab's social media presence and regulatory filings.
• Performs other duties as assigned.

Required Qualifications

• Bachelor's degree in Life Sciences or related field required; Master's degree in Life Sciences or related field preferred.
• 1-3 years related work experience required in clinical trials and/or regulatory.
• Solid understanding of FDA good clinical practice guidelines.
• Ability to maintain confidentiality and sensitive information, set priorities, and work independently and collaboratively.
• Advanced skills with Microsoft applications and other web-based applications.

Competencies

• Decision Making: Ability to make decisions guided by general instructions and practices.
• Problem Solving: Ability to address problems using analysis or interpretation of the situation using direct observation, knowledge, and skills based on general precedents.
• Independence of Action: Ability to follow precedents and procedures, set priorities, and organize work within general guidelines.
• Written Communications: Ability to communicate clearly and effectively in written English.
• Oral Communications: Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families, and external customers.
• Knowledge: Ability to demonstrate full working knowledge of standard concepts, practices, procedures, and policies.
• Teamwork: Ability to act as a team leader for small projects or work groups, creating a collaborative and respectful team environment, and improving workflows.
• Results: Ability to impact the operations of one or more departments.
• Customer Service: Ability to provide a high level of customer service to patients, visitors, staff, and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving.

Pay Range

$58,240.00 USD - $90,002.00 USD