Audrey Silvey
Clinical Research Professional
Maryland Heights,MO
Summary
With background in fast-paced healthcare environment, brings strong organizational skills and attention to detail. Adept at managing compliance and verification processes, and ready to transition into new field where these skills can be applied. Focused on ensuring efficiency and accuracy in any professional setting.
Experienced with credentialing processes and regulatory compliance in healthcare sector. Utilizes efficient database management and meticulous record-keeping to ensure accuracy and timeliness. Strong understanding of teamwork dynamics and adaptability, contributing to operational success.
Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.
Overview
9
9
years of professional experience
4
4
years of post-secondary education
Work History
Credentialing Coordinator (Remote)
MTM Transportation
10.2024 - 01.2025
- Review several hundred documents per day to stay ahead of incoming workflow.
- Responsible for obtaining and verifying appropriate credentialing documentation for all necessary stakeholders including, but not limited to: Drivers, Members, vehicles, and Transportation Providers, completing with a high level of accuracy.
- Accurately follow the credentialing protocols of Network and Client contracts.
- Review credentialing documents and determine whether compliance standards have been met; escalate to Legal Department as necessary.
- Ensure timely review of all documents.
- Make educated approval decisions based on assessment results.
- Lead calibration meetings to ensure compliance of stakeholders nationwide.
- Maintain metrics related to credentialing activity.
- Review the list of stakeholders that are currently not in compliance or those who are at-risk of becoming non-compliant and make appropriate determinations.
- Audit to ensure stakeholder compliance and communicate any necessary updates.
- Determine approval or rejection of stakeholder credentials.
- Make process recommendations to Legal Department, in efforts to improve quality and process.
- Audit contractual documents for accuracy and compliance.
- Run sanction checks, as required.
Study Data Specialist (Remote)
Clinical Ink
11.2021 - 11.2023
- Manage approximately 30 studies at once, providing oversight and ensuring that deliverables are met for all studies.
- Assist in developing training and mentor program for Study Data specialist team members
- Participate in project team meetings as Study Data team representative; provide updates on deliverables
- Monitor and work to maintain/improve client satisfaction by ensuring high quality service communication, and management of source data
- Handle both internal and external issue escalations; escalate issues to manager, project team, and/or Sponsor/CRO in a timely manner, and follow issues through to resolution
- Liaise between Sponsor, Project management, Clinical Programmers and Quality teams
- Work with Sponsor/CRO to determine Data Service deliverables
- Oversight, review and approval of study configurations and study database build
- Oversight, review and approval of data export mapping needs and the creation of data export specifications based on customer analysis/needs
- Ensure deliverables meet the expectations of ICH GCPs, data standards and internal procedures
- Ensure quality and on-time completion of all Data Services deliverables, including, but not limited to: Data Transfers, Custom reports, User Acceptance Testing, End of Study Documentation, Archiving
- Create and maintain all Data Services related study documentation association with each assigned study
- Provide support around presentations and/or training sessions and present to applicable client study team members at meetings such as Kick Off Meetings, Ad-hoc trainings, Data Export or Data Mapping questions, End of Study, etc.
- Contribute to the development and/or revision of Data Services SOPs and related documentation
- Participate in departmental discussions regarding technical, functional, and process involvement; assist in peer review/QC of department deliverables
- Triage, research and provide solutions for identified data issues
Clinical Data Coordinator (Hybrid)
Clario
09.2015 - 11.2021
- Manage data approximately 15 studies from study start-up to end of study, making sure that edit checks were functioning correctly and querying sites for any discrepancies.
- Support departmental workflow by taking action on discrepant data through investigation and issuance of queries to sites/sponsors to verify/obtain demographic and visit information on source data in accordance with departmental SOPs and SWIs.
- Communicate with Project Managers, Data Management, IT, Logistics, other Departments and Data Coordinators within the company to resolve client and database related queries and issues.
- Troubleshoot equipment, clarify protocol and handle equipment return issues with sites and Investigators during support calls.
- Investigate and enter resolutions and/or revisions received across operational systems within turn around time goal.
- Process source data across operational systems.
- File and organize source documents once workflow is complete and archive documents upon notification of study lock within requested time frame
- Maintain departmental metrics in accordance with goal plan.
- Participate in required training programs.
- Assist in training new hires.
- Report any equipment and/or system problems.
- Maintain accurate and complete Data Coordination files as defined by the department’s SOPs.
- Assist as requested with data reconciliation activities for my studies ensuring that database updates are complete within the Sponsor requested timelines.
- Volunteer participation and planning in work sponsored EPIC (Event Planning Initiative Committee) events.
- Cross-trained between Cardiac Safety and Respiratory Department.
- Initiated and completed archiving project for Respiratory Department.
- Initiated and completed organization of active/closed studies in Respiratory Department database.
Escalation Specialist Customer Relations (On-Site)
Trane Midwest
10.2018 - 03.2019
- (Note: Left Clario due to layoffs to work at Trane and returned to Clario within six months, per Clario Manager's request)
- Work directly with Trane/American Standard end users, homeowners, dealers and technicians via phone and email to ensure that the brand lives up to the company and client’s objectives and expectations.
- Work a log of homeowner complaints by taking on at least 5 complaints a week with a 95% resolution rate.
- Work in the highest tier of Consumer Relations that addresses and resolves all residential consumer complaints regarding dealers, equipment/installation issues. Addressed complaints on social media, to corporate, Better Business Bureau and Attorney General.
- Adhere to a set of guidelines and warranty terms to offer monetary assistance to consumers on a case by case basis.
- Collect and review documents and statements from homeowners and dealers to determine entire issue how determine to resolve it.
- Communicate with homeowners, dealers, technical support, warranty department, sales offices and other internal departments to gather information and provide solutions.
- Have a general understanding of functionality of HVAC equipment and terminology.
Education
Bachelor of Arts - Spanish
Missouri State University
Springfield, MO 08.2003 - 12.2005
Associate of Arts - General Studies
Jefferson College
Hillsboro, MO 08.2001 - 05.2003
Skills
- Data Entry Proficiency
- Electronic Data Capture (EDC)
- RAVE
- Good Clinical Practice (GCP)
- Clinical Data Management
- Quality Control
- Legal Compliance
- Project Plans
- Software Development
- Data Mapping
- CDISC Standards
- Salesforcecom
- Cross-functional Collaborations
Timeline
Credentialing Coordinator (Remote)
MTM Transportation
10.2024 - 01.2025
Study Data Specialist (Remote)
Clinical Ink
11.2021 - 11.2023
Escalation Specialist Customer Relations (On-Site)
Trane Midwest
10.2018 - 03.2019
Clinical Data Coordinator (Hybrid)
Clario
09.2015 - 11.2021
Bachelor of Arts - Spanish
Missouri State University
08.2003 - 12.2005
Associate of Arts - General Studies
Jefferson College
08.2001 - 05.2003
Similar Profiles
Wendy MarianiWendy Mariani
Bus Driver at MTM TransportationBus Driver at MTM Transportation
Jumirea FieldsJumirea Fields
Medical Transportation Specialist at MTM TransportationMedical Transportation Specialist at MTM Transportation
Tymica BurdTymica Burd
Customer Service Representative at MTM TransportationCustomer Service Representative at MTM Transportation