Ewa Heimlich

· Assist the site to oversee all aspects of the Regulatory Department, including:

· Manage all new study leads and ensure that CDA, FQs, etc. are submitted in a timely manner.

· Oversee timely and accurate submission of study start-up documents.

· Oversee timely and accurate submission of all continuing review documents

· Obtain and distribute IRB approvals, recruitment materials, IVRS and EDC access for all study staff, monitor study supplies and medication release.

· Schedule monitor visits in accordance with Principal Investigator and CRC schedules

· Host monitoring visit as well as FDA and Sponsor audits.

· Provide daily practical support to Investigators and all study staff members

· Facilitate communication between Site, Sponsor and CRO.

· Oversee regular maintenance of regulatory binders and contents for all active protocols

· Provide support to Financial Department in respect to clinical research budgeting

· Verifies if site and staff credentials are up to date and properly documented, including but not limited to: site equipment calibrations, CLIA waiver, medical licenses, CVs, training documentation

· Initiate and control single-handedly the entire study start-up process for 3 sites, 10 investigators and 50-60 studies per year.

· Obtain and distribute IRB approvals, recruitment materials, IVRS and EDC access for all study staff, monitor study supplies and medication release.

· Host study initiation visits as well as FDA and Sponsor audits.

· Oversee and document personnel training process, provide updates on Investigator Meetings, protocol amendments, webinars, refresher courses and other required certification.

· Provide daily practical support to 10 Investigators and all studies staff members and facilitate communication between Site, Sponsor and CROs.

· Maintain weekly operating reports.

· Organize training meetings and performance improvement meetings.

· Submit new studies to central Institutional Review Board and follow up submissions.

· Maintain regulatory files for all open protocols, provide necessary updates form study opening up to close out.

· Prepare for study close out. Archive activities.

· Cooperate with local laboratories regarding critical results.

· Enter study data into electronic CRFs (InForm, Tao, BIRT) as well as regular paper CRFs. Prepare clinical data for presentations (study poster)

· Maintain clinic logs for monitoring visits. Provide support for several study coordinators in daily activities and obtain necessary documentation.

· Help prepare study budgets and provide accounting of investigator initiated studies.

Maintain study binders for 74 open investigator initiated trials. Responsible for reviewing new patient information, 1572 FDA activities, cooperation with local IRB regarding Special Exception cases, verification and audit of all regulatory documentation, maintaining and updating CLIA logs.