Sr. Clinical Research Associate
Location: Natick, MA
About the Role:
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).
Responsibilities:
- 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
- Monitor site performance indicators, including enrollment, protocol compliance, data entry, query resolution, etc.
- 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
About You:
- Strong organizational skills and disciplined follow-through
- Ability to independently identify, assess, escalate, and resolve operational risks
- Strong understanding of site monitoring and CROs
- Excellent written and verbal communication
- 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
Personal Attributes:
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.
Education and Experience:
- Bachelor’s degree in life sciences or related field (required)
- 5 years of CRA experience including a minimum of three years performing independent site monitoring supporting multicenter Phase 2 or Phase 3 clinical trials.
- Previous experience in a CRO environment required; sponsor or small biotech experience preferred.
- Experience using EDC, CTMS, eTMF and related clinical trial systems.
- Strong knowledge of ICH-GCP, FDA regulations, and clinical trial conduct
- Demonstrated ability to work independently in a fast-paced, resource-lean environment
- Willingness and ability to travel domestically and internationally based on program needs, potentially up to 30-40% during periods of increased study activity.
About Us:
Headquartered in Natick, MA, we have all the perks you can find in Cambridge (short distance to lunch, shopping, etc.) and more perks that you can’t:
- Ample free parking
- Easy/quick access to Route 9 and Mass Pike (equal distance to Route 495 or Route 95/128)
Anagram Therapeutics offers competitive compensation, including equity, and a comprehensive benefits package that includes medical, dental, short- and long-term disability, AD&D, 401(k) retirement plan, and an Employee Referral Program.
We are an equal employment opportunity employer and do not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Interested candidates contact us at careers@anagramtx.com