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.
The Lead Patient Guide will oversee the day-to-day operations on a variety of virtual clinical research studies. Collecting, recording, reporting, and interpreting information from patients enrolled and/or seeking enrollment in our virtual studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Carry out complex duties to ensure projects meet intended goals. Assist with daily workload planning.
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
Recruit and screen patients for clinical trials and maintain subject screening logs;
Schedule and execute study visits and perform study procedures;
Handle lab vendors working with virtual sites and the lab logistics;
Assist with study data quality checking and query resolution
Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards
Provide training to new investigator site staff members on study-specific topics and requirements.
Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies, as needed.
Assist research team and virtual sites with coverage planning related to staffing and scheduling for research projects
Escalate issues and concerns to Virtual Trials Operations Manager/CRA/Clinical Lead
May communicate directly with vendors and other business partners; act as liaison for group when communications stall.
Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits
Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness;
Monitor subject safety and report adverse reactions to appropriate medical personnel;
Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring.
Record, report and interpret study findings appropriately to develop a study-specific database.
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