ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Support Clinical Operations Study Lead/Clinical Trial Manager (CTM) in the drafting/review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports

• Support and implement trial set-up, execution, generating reports for clinical studies

• Independently perform tasks related to the day-to-day clinical trial management with the implementation and conduct of clinical trials, enrollment, site management and monitoring oversight, data quality and study reporting

• Collect, track and conduct initial review for completeness of site regulatory documents for investigational product release and/or TMF filing, with CTM oversight

• Support and/or contribute to the creation and maintenance of study materials, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, site tools, study communications and presentations

• Manage third-party vendor with CTM oversight to ensure timely delivery of services/materials and coordinate activities, including vendor provided meeting minutes, study updates and trackers

• Maintain trackers following the progress of assigned clinical trials, such as study subject tracking, essential document tracking

• Tracking trial investigational product, clinical lab samples and lab data, sample shipments and reconciliation with sites, as needed

• Support CTM/Sr CTM in the review, tracking and follow-up of monitoring visit reports and unresolved issues

• Collect and collate site feasibility data

• Facilitate the execution of new CDAs and site contracts through the established legal approval process (CTAs, MSAs, work/task orders)

• Perform first pass review of site and some vendor invoices including tracking and generation of monthly/quarterly accruals

• Communicate directly with sites, Contract Research Organizations (CROs) and field CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close-out activities

• Responsible for the scheduling, agendas and minutes of internal clinical team meetings and other trial-specific meetings

• Receive and review regulatory documents from sites (direct or through CRO) for accuracy and compliance with applicable SOPs and regulatory guidelines

• Ensure timely updates of required trial registry websites, with CTM oversight

• Support the team in the development, review and implementation of departmental SOPs and processes

• Organize, maintain and participate in the audit and close out of the Trial Master File (TMF/eTMF)

• Participate in the EDC / IRT specification and user acceptance testing (UAT) processes, as appropriate

• Other duties may be assigned

• Strong, professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high quality work while managing competing priorities and maintaining tight timelines 

• Must be interested in working in a fast-past and team-oriented environment with the ability to effectively collaborate with the study team, cross-functional team members, and external partners