Site Engagement Coordinator

The Site Engagement Coordinator will work under the Executive Director of Clinical Trial Operations and the Associate Director of Clinical Trial Operations to oversee activity within the Alliance for Clinical Trials in Oncology site network across the Alliance Foundation Trials portfolio of clinical research projects.

This position will help to track and maintain up to date metrics on site performance including: site recruitment - both overall policy and trial specific; patient recruitment and retention planning; site initiation; ongoing site management; and remote site monitoring and site close-out activities. The Site Engagement Coordinator works in partnership with the Executive Director and Associate Directors of Clinical Trial Operations, as well as individual study teams to ensure all site selection and oversight activities are compliant with AFT SOPs and Alliance for Clinical Trials in Oncology membership standards.

The Site Engagement Coordinator will also be responsible for assisting AFT study teams with management of the electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS). Responsibilities will include management of shared eTMF inbox, document uploading, indexing, filing and review as necessary, as well as collaborative work with AFT QMC and Ops teams to develop processes for management of overdue or missing documents in the eTMF.

• In conjunction with the Clinical Operations leads, Director of Information technology, and lead CRPs at Alliance sites, ensure optimal capture of Alliance site information in all necessary systems and databases.
• Oversee/maintain the data located in the Site Management tab of the CTMS (Global site management) with routine reviews/audits. Provide support to enable project teams to maintain study-specific site management information.
• Ensure all participating sites on AFT trials are Alliance members in good standing prior to formal site selection. For sites not in good standing, work with the Clinical Operations leads to determine eligibility for participation in AFT trials.
• Ensure site/study close-out is conducted according to GCP, internal SOPs and policies, and within required timelines.
• Debriefs with Alliance Sites after completion of site activation on AFT trials to get feedback and guidance on ways to improve AFT startup processes.
• Working with the Project Managers is accountable for the quality and consistency of site management activities and compliance with SOPs.
• Oversees all patient transfers and ensures AFT SOPs are followed before any patient transfers are finalized.
• Builds positive relationships with principal investigators and site personnel.
• Actively participate in clinical trial operations with the study team to stay current with study needs, communicating as needed with sites within defined timelines.
• Primary liaison to Alliance membership manager for exchange of site level performance information.
• Serves as primary manager of the AFT eTMF and Site Engagement inboxes and manages incoming documents for AFT study teams.
• Works with QMC and AFT Ops to implement process for following up on missing or overdue documents in the eTMF.

• A minimum of a BA/BS degree is required
• Degree in a health or science major preferred
• Minimum two years clinical research experience required, particularly in site management area
• Solid understanding of the drug development process, including Good Clinical Practice (GCP) and FDA Code of Federal Regulations.
• Fully COVID-19 Vaccinated
• Solid computer skills, including a working knowledge of various CTMS, TMF, eReg, and EDC software
• Strong Microsoft Excel skills
• Understanding of general clinical research operations at institutions/sites
• Excellent organizational, leadership, and problem-solving skills
• Excellent written and verbal communication skills
• Ability to successfully work both within a team and independently
• Ability to travel several times a year

• 100% Medical option, Dental & Vision for employee, with 50% spouse and children - begins on the 1st day of employment
• 20 Days PTO, 5 Sick Days & 10 Holidays Off (Already Designated)
• Tuition Reimbursement
• Match 3% of a Simple IRA.
• 50% Transit or Parking paid
• Annual Employee Bonus Program
• Annual Cost of Living Increase