Wendy Bigger Email & Phone Number

Durham, North Carolina, United States

- Managed multiple aspects of clinical trials, providing timely updates and escalating issues as needed.- Supported amendments, trackers, and site follow-up for smooth study execution.- Developed reports to summarize study progress and status for management.- Provided comprehensive site support during study start-up, ensuring collection and communication of essential documents, supplies, and study information.- Assisted with document collection and tracking (IRB submissions, procurement), supply shipment to sites, and internal/external document review.- Maintained clinical trial master files (TMF/eTMF) and ensured documentation accuracy.- Coordinated study team activities on behalf of study management.

Littleton, Colorado, United States

- Adhered to research department Standard OperatingProcedures (SOP's), Good Clinical Practices (GCP)Guidelines, regulations necessary for the Protection ofHuman Subjects (PHRP), federal regulations governing theconduct of clinical research, and the policies andprocedures as outlined by the individual study protocols- Ensure scientific integrity of data while protecting therights, safety, and well-being of patients enrolled in clinicaltrials- Assisted Principal Investigator to assure that all staffmembers assisting with data collection or participation inthe clinical research studies have met education andtraining requirements in accordance with federalregulations- Maintained documentation of staff members' clinicalresearch education and training- Collaborated with the PI and sponsors to prepareInstitutional Review Board (IRB) and any other regulatorysubmission documents as required by the protocol- Prepared study materials to include the informed consentdocument, case report forms (CRFs), enrollment logs, anddrug/device accountability logs- Established and organized study files, including but notlimited to, regulatory binders, case report forms, and studyspecific source documentation- Collected documents needed to initiate the study forsubmission to the sponsor (e.g., FDA Forms 1572, CVs, etc.)- Coordinated and facilitated monitoring and auditing visits- Collaborated with PI and research department staff torespond to any monitoring/audit findings and implementapproved recommendations- Facilitated the tracking of research study visits, providedmonthly reporting on the department financials toaccounting team, practice owners and PracticeAdministrator, and provided a reconciliation of maintainingthe research department budget- Requested and track research subject reimbursementsafter study visits are performed- Managed all aspects for sponsor invoicing and accountsreceivable

Littleton, Colorado, United States

- Facilitate all research administrative tasks and data entry- Answer incoming calls regarding patient care- Review patient charts to screen for study qualification- Facilitate communication between physicians, technicians,and patients- Maintain and manage patient digital profile and electroniccharting systems- Appropriately file regulatory documents in site Trial Master File- Submit protocols to IRB and FDA- Track, file, and implement protocol amendments- Oversight of patient reimbursement payments

Highlands Ranch, Co

Remote

- Quoted and met with prospective clients.- Assist agent with document completion and filing.- Audit accounts to ensure accuracy.- Research client policy inquiries.

Wichita, Kansas, United States

- Monitored and interpreted electrocardiogram rhythms.- Collaborated with Registered Nurses to provide optimal patient care.- Ensured the safety and ethical treatment of patients.- Established effective communication and relationships with all departments.