In-House Sr. Clinical Research Associate; to Perm

Anagram Therapeutics is seeking a hands-on, collaborative In-House, Sr. Clinical Research Associate who will provide sponsor side oversight and hands on operational support for global clinical trials. This role is a 6-9 month consultant role with the potential to become a permanent position. This position will focus on site performance, CRO monitoring oversight, site enrollment, data quality/tracking, protocol compliance and timely resolution of operational issues.

In a small biotech environment, the successful candidate must be comfortable working independently, identifying risks early, and taking ownership of follow-up through resolution. The role will conduct sponsor oversight, co-monitoring, remote monitoring and targeted site visits as needed to supplement CRO activities and address risks and support enrollment and data completion objectives.

Domestic and international travel will be required as needed (estimated up to 30-40% at times based on project need).

• Perform sponsor oversight, co-monitoring, and/or targeted on site visits based on study needs
• Serve as a sponsor point of escalation for site issues, protocol deviations, and data quality concerns from a monitoring perspective
• Assess site readiness for activation, enrollment, subject visits and study closeout.
• Support TMF completeness and inspection readiness, ensuring accurate and timely documentation
• Track samples and supplies as needed for a study
• Provide focused support to high risk or underperforming sites
• Support the onboarding, training and study specific readiness of CRO CRAs
• Maintain accurate trackers, documentation and status reporting for assigned activities
• Contribute to the development and improvement of clinical operations processes and tools
• Contribute to audit and inspection readiness activities and support responses to monitoring related findings.
• Other responsibilities associated with trial operations and clinical development as needed

• Strong organizational skills and disciplined follow-through
• Ability to independently identify, assess, elevate, and resolve operational risks
• Strong understanding of site monitoring and CROs
• Ability to manage multiple priorities with limited oversight
• Hands-on, solution-oriented mindset
• Comfortable operating in a small biotech / startup environment where priorities may evolve
• Strong collaboration skills across internal functions, CRO teams, vendors and clinical sites

Execution:
Demonstrates and fosters a winning mind set, a sense of urgency, optimism, and ownership, and a strong drive to achieve goals and organizational success. Delivers business results for the organization. Accountable for effectively and efficiently completing work responsibilities and tasks with high quality. Demonstrates initiative, works to achieve results, meets or exceeds goals, and acts on opportunities to create value

Collaboration:

Promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-cultural communication and collaboration in all interactions. Credits others for their contributions and accomplishments.

Communication:
Prepares and delivers clear, concise, accurate, effective, and persuasive written and verbal materials/messages. Attentively and accurately listens to others. Promotes a free and timely flow of high-quality information between self and others and across the organization; encourages the open expression of ideas and opinions.

Adaptability:
Responds resourcefully, flexibly, and positively when faced with new challenges and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively under conditions of change or uncertainty.