Job Title:
Site Management
Department/Group: AFT Foundation
Location: Boston
Level/Salary Range: $
Job Description
Clinical Research Associate, Job Category: Exempt Non-Exempt
Reports to: Site Manager
Travel Required: Occasional
Position Type: Full-Time Part-Time
Contract Temporary
Date posted: Click here to enter a date. HR Contact: Tara Mangan
External posting URL: Click here to enter text.
Internal posting URL: Click here to enter text.
AFT Mission:
Alliance Foundation Trials, LLC (AFT) sponsors and conducts high-quality cancer clinical trials funded exclusively by non-NCI (National Cancer Institute) sources. AFT leverages the internationally recognized scientific experts and thought leaders of the Alliance for Clinical
Trials in Oncology with its expansive and established network of hospitals, medical centers, and community clinics across the North America.
Purpose/Scope:
The CRA is responsible for managing various aspects of AFT site management strategy, including but not limited to administration of the CTMS system, Study trial master file set up and maintenance, CRO vendor oversight, and site feasibility and start up activities.
R OLE AND R ESPONSIBILITIES

Assist Site Manager in supporting the Alliance member sites and act as the back up to the
Site Manager when dealing with site related issues

Review and approval of regulatory documents for IP release, during the study and for site close-out
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Filing of study documentation in electronic Trial Master File (eTMF)
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Quality Review of TMF: Ensures proper and timely filing of all relevant study documents on an ongoing basis; to ensure compliance with applicable work instructions, SOPs and ICH GCP guidelines and AFT expectations. Performs routine review of filing procedures to ensure adherence to current guidelines at all times.

Review of Monitoring Reports to identify deficiencies, adequacy of issue escalation and issue resolution
 Communicates with CROs, Vendors, and/or study sites as necessary to support the study
 Maintain site information and roster in the AFT Clinical Trial Management System (CTMS).
 Conduct regulatory review of ICF changes and coordinate review by executive officer and senior contracts manager (legal purposes) as necessary.
 Assist with site selection and recruitment by generating site identification reports (e.g., site accrual), collecting, reviewing and tracking site feasibility/credentialing documentation.
 Assist with preparation and execution of Investigator meetings and other site training programs.
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 Organize study related meetings; take detailed minutes at meetings on decisions and action items and distribute to the team, as assigned.
Q UALIFICATIONS AND E DUCATION R EQUIREMENTS
 A minimum of a BA/BS degree is required.
 Degree in a health or science major preferred.

2 – 4 years relevant biotech/pharma, and/or CRO, with 1 year industry experience
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Working knowledge of Clinical Monitoring responsibilities and procedures.
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Working knowledge of Clinical Trial Master File requirements.
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Software skills should include MS Office (Excel and Word)
P REFERRED S KILLS
K NOWLEDGE OF INDUSTRY STANDARDS AS APPLIED TO ICH GUIDELINES , GCP, AND THE CFR
A DDITIONAL N OTES
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