Senior Clinical Research Associate at Immatics US Inc
Overview
Lead clinical trial site management and monitoring to ensure compliance with ICH-GCP and regulatory standards. Oversee high-quality study execution and patient recruitment while driving operational excellence remotely. This role shapes cancer immunotherapy impact one patient at a time.
What You'll Do9
- 1Conduct all clinical monitoring activities including site qualification and close-out visits
- 2Support site feasibility and ongoing management throughout the clinical trial lifecycle
- 3Review trial progress and implement actions to achieve study objectives
- 4Maintain accurate monitoring documentation including trip reports and trial master files
- 5Collaborate with vendors and cross-functional teams to ensure operational compliance
- 6Participate in investigator meetings and contribute to documentation development
- 7Mentor junior CRA team members and improve clinical operations processes
- 8Travel up to 75% to support site engagements and headquarters meetings
- 9Drive quality and efficiency initiatives in clinical operations
Requirements9
- 1Bachelor’s degree in life sciences nursing or related field with 4+ years on-site monitoring experience
- 2Strong knowledge of ICH-GCP FDA EMA regulations and clinical trial requirements
- 3Proficiency with CTMS eTMF and Microsoft Office tools
- 4Experience in oncology clinical trials or related therapeutic areas
- 5Demonstrated leadership in site management and regulatory compliance
- 6Excellent presentation organizational and stakeholder management skills
- 7Track record of mentoring junior staff and improving operational workflows
- 8Understanding of clinical trial recruitment strategies and data capture best practices
- 9Commitment to global harmonization and process optimization initiatives
Salary Insight
$120 - $135k per year
Location
Required Skills
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