• Establish and manage study lifecycles in the electronic Trial Master File (eTMF), ensuring document completeness and compliance with regulatory standards.• Assist Clinical Research Associates and site personnel with document collection, review, and maintenance, while providing guidance to junior Clinical Trial Associate team members.• Create and maintain operational tracking tools for Key Performance Indicators and quality metrics, and participate in Clinical Inspection Readiness activities.• Contribute to project team meetings with minute preparation and action log maintenance, and support the training and onboarding of new staff members.

• Verified and documented any necessary changes due to discrepancies for complete quality assurance.• Performed daily/ongoing management of protocol queries to ensure accurate information in databases.• Reviewed reports received for completeness and consistency according to SOPs and sponsor protocols.• Establish and maintain the Trial Master File (TMF) in inspection-ready state.• Performs study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.• May serve as an Independent Essential Document Reviewer and/or perform second review of Essential Documents.• Liaises with internal and external customers to meet project specific goals including participation in sponsor and project related meetings.• Assists with resolution of investigational site/data queries.• Documents site and Sponsor contact and study interactions in a timely and professional manner.• Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.• Interacts with site, clients, vendors and PRA functional areas as secondary project contact for site issues and questions.• Ensure accurate and timely review and filing of clinical trial related materials.• Establish and maintain the Trial Master File (TMF) in inspection ready state.

➢ Processes data and queries for assigned clinical trials and ensures appropriate updates are made for sponsors prior to potential FDA submission● Process data using all active Cardiac Services’ systems and databases (i.e. Cami, eStore, Expert, GLS, OnBase, MUSE)● Review reports received for completeness and consistency according to SOPs and sponsor protocols● Verify and document any necessary changes due to discrepancies for complete quality assurance● Collaborate with sponsors and sites to ensure ERT data, for individual studies, are identical to eCRFs● Perform daily/ongoing management of protocol queries to ensure accurate information in databases● Prepare and assign reports to study-specific cardiologists for review● Initiate contact with cardiologists for any STAT over-reads to ensure patient safety

**Through acquisition, Biomedical Systems is now known as ERT. ➢ Processed data and queries for assigned clinical trials and ensures appropriate updates were made for sponsors prior to potential FDA submission● Communicates with investigative sites, coordinators and referral sources both verbally and in writing to ensure patient data questions are clarified, documented and processed in a timely manner● Review pulmonary reports received for completeness and consistency according to SOP’s and Sponsor protocol● Perform daily/ongoing management of data queries, Verify and properly document any necessary changes due to discrepancies● Prepare and send reports to over-reading clinicians and sponsors for review● Complete edit checks, audits and report findings to the assigned Clinical Project Manager● Technical support telephone coverage for daily incoming calls● Customer service support to the investigative sites as needed.● Had the ability to troubleshoot simple computerized pulmonary function systems to help sites with ongoing issues.

➢ Applied appropriate coding and billed charges to insurance companies, posted payments to patients’ accounts and filed many appeals on patients’ behalf● Interpret data/information into alphanumeric code● Post charges for assigned doctors’ accounts on a timely and accurate basis● Perform checks and balances on all charges to ensure data entry reconciles to source documents● Collect, post and manage account payments● Submitting claims to insurance as well as processing insurance and patient payments● Prepare and review detailed statements● Follow up on accounts and call for collection● Data entry in to applicable systems (Medical Manager Software)● Integral knowledge of several different coding systems● Investigate accounts for possible fraud

➢ Scheduled multiple tests and procedures for all physicians while obtaining prior authorizations for such tests● Check patients out following physician visits● Schedule various tests and surgical procedures● Obtain insurance precertification’s● Data entry (EPIC Software)● Manage phone and physician schedules while performing general office duties● Collect copays and payments on accounts

➢ Schedule multiple tests, procedures and follow-up appointments for all physicians in the practice● Check patients in & out following physician visits● Schedule various tests and surgical procedures● Data entry● Manage phone and physician schedules while performing general office duties