Clinical Research Associate

Responsibilities

• Support site initiation, ongoing site management, and close-out activities in accordance with sponsor oversight plans and study timelines.
• Ensure clinical trial conduct complies with study protocol, ICH-GCP, FDA and global regulatory requirements, and company SOPs.
• Participate in data review and data cleaning activities to support data snapshots, as assigned.
• Review site status, enrollment progress, data trends, and action items to support efficient trial execution and escalate issues in a timely manner to the study lead and oversight director
• Provide oversight of CRO CRAs, participate in co-monitoring
• Provide oversight of CRO site management activities
• Maintain a compliant and contemporaneous study Trial Master File. Responsible for ensuring documents are filed correctly and timely, provide oversight of the CRO TMF management activities
• Perform regular TMF review and QC checks to ensure TMF health
• Participate in protocol deviation review and management of PDs
• Contribute to authoring and review of study documents and training materials
• Support site readiness and issue resolution through ongoing follow-up and communication with study sites
• Partner with patient operations to support certain cell therapy logistics operations, as needed
• Participate in the review monitoring reports, follow-up letters, and site action plans prepared by CRO CRAs and support issue resolution as needed.
• Support inspection readiness activities and support the team in regulatory inspections or audits as needed.
• Support metrics review and feedback for assigned clinical trials.
• Identify and escalate site compliance issues, protocol deviations, and patient safety concerns.
• Partner with cross-functional study team members on ongoing study activities and contribute to study team meetings
• Build strong relationships with clinical trial sites and serve as the sponsor point of contact for site staff

Qualifications

• Bachelor's degree in life sciences, nursing, or a related field required; advanced degree preferred.
• Minimum of 3+ years of clinical operations experience in biotech, pharma, or CRO environments. Must have Sponsor side experience.
• Prior experience supporting site management, CRO oversight, or co-monitoring activities strongly preferred.
• Prior experience monitoring cell therapy, gene therapy, immunology, or other complex therapeutic areas strongly preferred.
• Strong knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements.
• Experience with EDC systems, CTMS, eTMF, and safety reporting processes.
• Familiarity with risk-based monitoring approaches.
• Prior inspection or audit support experience preferred.
• Exceptional attention to detail and organizational skills.
• Strong written and verbal communication skills.
• Ability to manage multiple sites and priorities independently.