Clinical Research Associate

About the organization

The Alliance for Clinical Trials in Oncology Foundation was established to broaden the capacity of the Alliance for Clinical Trials in Oncology to run large-scale cancer clinical trials and answer critical treatment questions. Its work supports research aimed at finding better ways to prevent, treat, and cure cancers such as leukemia, lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal tract, while also helping educate the medical community on cancer diagnosis, treatment, and prevention.

In May 2014, the Foundation launched Alliance Foundation Trials, LLC (AFT), a wholly owned subsidiary created to conduct cancer clinical research and address medical care and treatment through large-scale clinical trials with industry partners.

Role overview

Alliance Foundation Trials is hiring a Clinical Research Associate to help manage and execute clinical trial operations across AFT studies. This position focuses on site management and study start-up work such as feasibility review, support for site selection, maintenance of the electronic trial master file, and oversight of trial systems like CTMS. The role works closely with CROs, vendors, and investigative sites to keep studies aligned with ICH GCP requirements and internal standards from startup through ongoing study maintenance.

What you'll do

• Support the operations team in working with Alliance member sites and raise site-related issues when needed.
• Send, monitor, and assess study-specific as well as global feasibility questionnaires.
• Help with site selection and recruitment by preparing site identification reports, tracking feasibility and credentialing documents, and following up on accrual-related activity.
• Maintain training records and issue training materials for sites and contacts.
• Collect essential study-startup documents and review investigational product release packages.
• Prepare and help run investigator meetings and other site training sessions.
• Assist in building study startup plans and related templates.
• Keep all required study records filed accurately and on time in the eTMF in line with work instructions, SOPs, ICH GCP, and AFT expectations.
• Review filing practices regularly to ensure they meet current quality standards.
• Enter and maintain study information in CTMS, including training history, site rosters, monitoring report review, issue escalation tracking, resolution status, and feedback to CRO contacts.
• Take part in co-monitoring activities.
• Communicate with CROs, vendors, and study sites as needed, including monitoring study email inboxes.
• Review regulatory changes to informed consent forms and coordinate review with the Executive Officer and contracts team.
• Organize study-related meetings, record detailed minutes, capture decisions and action items, and circulate notes to the team.
• Perform additional duties as assigned to support departmental and organizational goals.

Benefits and workplace support

• 8 weeks of paid time off in the first year, covering PTO, sick time, and holidays.
• Medical, dental, and vision coverage, including a fully employer-paid option for employees.
• Tuition reimbursement support.
• Continuing education opportunities.
• 3% employer retirement match.
• Annual employee performance bonus program.
• Annual cost of living adjustment.
• 50% commuter reimbursement.
• Flexible, healthy work/life balance.

Required qualifications

• A BA/BS degree is required.
• A background in a health or science discipline is preferred.
• 2 to 4 years of relevant experience in biotech, pharma, and/or CRO settings, including at least 1 year in clinical research.
• Working understanding of clinical monitoring responsibilities and procedures.
• Prior hands-on experience with eTMF, CTMS, and IRT systems is strongly preferred.
• Advanced proficiency with Microsoft Office, especially Word and Excel.

Preferred strengths

• Excellent organization and the ability to manage priorities in a fast-moving environment with tight deadlines.
• Strong people skills along with clear written and verbal communication.
• Comfort working in a small-business environment that requires flexibility and adaptability.

Additional information

This is a full-time, onsite role based in Boston, MA. The role supports clinical trial operations for cancer research programs and requires collaboration with cross-functional internal and external stakeholders.