Amanda C. Email & Phone Number

Remote

Flexible Resource on assignment to Seagen

Michigan, United States

United States

Prepare and submit Central IRB documentation and provide support to central and local IRB/ECs during reviews. Assist in the review of the site modifications of the ICF template and completes the ICF Checklist Issue site communications such as site activation letters and site closeout notifications Track screening and enrollment activity; obtain logs from.

Ann Arbor, Michigan

• US and global safety lead which entails direct correspondence with client, site, clinical team, and adjudication services team members to ensure the highest case quality, report deliverables, concise case narratives.
• Quality control (QC) of SAEs (serious adverse events) and ESRs (Expedited safety reports)
• Processing of SAE reports and applicable expedited reports for several post market and clinical trials which entails entry into databases, trackers, quality control review, collaboration with medical staff, site.
• Mentor other contractors/colleagues on all aspects of case-handling and serious adverse event reporting, as well as providing employee onboarding training.
• Extensive experience with Argus, RAVE, Inform, Citrix, and ARISg. This includes case processing, troubleshooting, process improvement, and report generation.

Greater Chicago Area

Collected, reviewed, and tracked regulatory documentation, retrieved and distributed safety ad hoc reports, performed document processing with redactions, maintained files including periodic file reviews, performed all safety adverse event processing functions until completion of a case, attended bi-weekly meetings and obtained information to process.

Attended Investigator Meetings, kick-off meetings, conducted phone screens for eligibility, screening/randomization/follow up visits, dispensed study drug, maintained drug accountability, performed blood draws and processed samples for shipment, maintained the regulatory binder (updating/submitting regulatory documents).

Attended Investigator Meetings, kick-off meetings, conducted phone screens for eligibility, screening/randomization/follow up visits, dispensed study drug, maintained drug accountability, performed blood draws and processed samples for shipment, maintained the regulatory binder (updating/submitting regulatory documents).