The Virtual Trials Study Coordinator will work with the Virtual Trial Study Lead and Site Operations Manager for supporting the Virtual Trial Solutions Clinical Operations Group and their assigned studies.
Specially developed, secure platforms have been implemented to interact with the virtual study patient along with the sites and project vendors to ensure the patient-experience is high-quality, secure and pleasant.
Essential Functions :
Provide clinical research support to investigators and their study staff to prepare for and execute assigned research studies as part of the Virtual Trials Solution Group, including :
Serve as liaison between the Virtual Trials Site Operations group and virtual study site.
Resource to Patient Guides and Study Concierge on their assigned projects; provide first-line guidance to study teams on protocol, Case Report Forms (CRFs) completion, other study-specific documents, and virtual trial platforms / systems used to record clinical research data;
Generate protocol work flow files for virtual study visits
Assists with or contributes to the development of study documents / manuals for virtual study
Perform IRB activities on behalf of sites.
Track submissions, review approvals, and close-out notices.
Independently develop and maintain effective tracking systems to ensure regulatory documents are compliant, including process flows, training manuals, and SOPs to be used.
Support development of relevant tracking tools and other internal processes to increase departmental efficiency.
Generate and review reports (protocol deviation, adverse events, monitoring), for compliance to protocol
Monitor the collection of regulatory documents as required by FDA and other regulatory / ethics bodies governing the conduct of clinical research
Independently develop training mechanisms for study-level Patient Guides / Virtual Study Coordinators on projects and documentation processes
Assist with the onboarding and training of new hires. Develop mentoring / coaching processes
Provide oversight for team members maintaining patient-level documentation in virtual platforms
Participate in huddles to confirm daily study tasks are assigned to team members and are executed to the expected standards;
Attend all relevant study meetings
Bachelor's degree in life science or related field
3 years of relevant experience in a scientific or clinical environment, or equivalent combination of education, training and experience
Advanced in English