Alliance FOR Clinical Trial IN Oncology Foundation

Clinical Research Associate

Boston, Massachusetts, United States

Sponsorship not specifiedDetected 106 days ago

GCPClinical TrialsClinical ResearchResearchLab ResearchCommunicationAdaptabilityOrganizational SkillsMicrosoft Office

About the role

In May 2014, the Foundation created the Alliance Foundation Trials, LLC (AFT), respectively, a wholly-owned subsidiary of the Foundation.
Come join an organization full of passionate, team-oriented professionals driven to change the face of cancer.

The Alliance Foundation Trials (AFT) is seeking a Clinical Research Associate (CRA) to support the management and execution of clinical trial operations across AFT studies.
This role is responsible for key site management and study start-up activities, including feasibility assessments, site selection support, maintenance of trial master files (eTMF), and oversight of clinical trial systems such as CTMS.
The CRA will collaborate closely with CROs, vendors, and investigative sites to ensure studies are conducted in compliance with ICH GCP guidelines and organizational standards, while supporting studies from start-up through ongoing maintenance.
Communicate with CROs, vendors, and/or study sites as necessary to support the study, which includes monitoring email accounts related to studies.
Collection of essential documents related to study start-up and review IP release packages.
Ensure proper and timely filing of all relevant study documents into the eTMF on an ongoing basis to ensure compliance with applicable work instructions, SOPs and ICH GCP guidelines and AFT expectations.
Perform routine review of filing procedures to ensure adherence to current quality guidelines at all times.
Accurately enter and manage data within the

A minimum of a BA/BS degree is required.
4 years relevant experience in biotech, pharma, and/or CRO, including 1 year of clinical research industry experience.
Working knowledge of clinical monitoring responsibilities and procedures.
Strong organizational skills and ability to prioritize workload to meet tight deadlines in a fast-paced and dynamic work environment.

Previous experience with eTMF, CTMS, and IRT clinical trial systems is strongly preferred.
Proficient in Microsoft Office Suite, especially Word and Excel.

AFT was also created to conduct cancer clinical research and address medical care and treatment through large-scale clinical trials involving various industry-related partners.

This listing is sourced directly from Alliance FOR Clinical Trial IN Oncology Foundation's careers page and normalized into a canonical job model.