Kimberly Medlin Email and Phone Number

•Develop and submit Institutional Review Board [IRB] documents such as consent forms, protocols, and continuing reviews. Maintain study level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. •Provide regulatory and safety reports.•Maintain study compliance according to institutional requirements, protocols and other applicable policies such as NIH Public Access policy, ct.gov, and Research Data Security Plans.•Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific •Work closely with study sponsors on regulatory and safety issues.•Prepare for study monitoring and study audit visits. Assist with addressing and correcting findings from study monitoring and study audit visits.•Complete and submit Adverse Events

•Assist with clinical, regulatory, business and other documentation associated with oncology research projects/clinical trials•Maintains Appropriate documentation for assigned studies•Assist In maintaining clinical trial compliance by reporting Issues and problems appropriately.•Supports the clinical trial team to efficiently complete task Including documentation, serious adverse events (SAEs)/safety reports

•Verifying insurance and validating membership.•Submitted Insurance claims based on providers charges•Customer satisfaction and greeting

•Ensuring privacy and accuracy to healthcare records.•Responsibilities were to release to Attorneys for legal and disability purposes.•Testifying In court hearings for the accuracy of records•Speaking with patients and requestors for status updates•Verified the ICD 9 codes for billing