The Study Concierge will work with the Lead Study Concierge and Virtual Coordinator supporting the Virtual Trial Solutions Clinical Operations Group and their assigned studies.
Specially developed, secure, platforms have been implemented to interact with study patients along with the sites and project vendors to ensure the patient-experience is high-quality, secure and pleasant.
The Study Concierge role supports all aspects of the virtual clinical trial operations from start-up to close-out; collecting, recording, reporting and interpreting information from patients enrolled and / or seeking enrollment onto our virtual studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP).
The Study Concierge carries out complex duties to ensure projects meet intended goals and assists with daily workload planning.
Essential Functions :
Provide clinical research support to virtual site investigators to prepare for and execute assigned research studies, including :
Review and become proficient with virtual study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to collect and record clinical research data;
May collect and submit regulatory / ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research;
Maintain subject screening logs;
Develop tracking logs and maintain source documentation based on protocol requirements;
Assist with the scheduling of virtual study visits in conjunction with Virtual Coordinator / Patient Guide and the virtual site;
Collect, record, and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness;
Correspond with virtual research subjects and troubleshoot study-related questions or issues;
Assist Patient Guides / Virtual Study Coordinators with gathering responses and communicating with virtual study participants
Participate in huddles to confirm and execute daily study tasks are executed to the expected standards;
Assist with study data quality checks and query resolution.
Assist virtual investigator and site staff in verifying that research study objectives are met on time and according to applicable protocol requirements, clinical research regulations and quality standards.
Provide training to new investigator site staff members on study-specific systems / platforms and requirements.
Assist virtual investigator and site staff with training requirements for compliance and documentation of such trainings.
Assist with other regulatory compliance documentation collection as needed
Assist research site with coverage planning related to staffing and scheduling for research projects.
Attend all relevant study meetings;
Facilitate shipment study supplies to study sites, including monitor Investigational Device inventory and liaison with Clinical Supply Management.
Prepare and send study-related documents and materials to virtual sites on behalf of sponsor.
The Study Concierge should have demonstrated ability to solve problems, be detail-oriented, and strong interpersonal skills.
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