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 regional CRAs and/or clinical sites. Discuss recruitment issues and strategies with study team Prepare site regulatory documents and packages. Review study site regulatory documents and approve documents in eTMF using ALCOA-C criteria during all phases of the trial(s) Oversee study, country, and site level TMF creation and maintenance Assist with onsite monitoring visits, including ensuring all materials are received at the clinical site prior to the scheduled Site Initiation Visit (SIV), Interim Monitoring Visit (IMV) and Close Out Visit (COV), review site data entry, queries, etc. and alert Data Management of upcoming IMVs to ensure up to date reviews. Communicate with sites as applicable to ensure study supplies are adequate and assist with re-order as needed Support activity around investigational product inventory supply requirements including proactive management of required study supplies (storage, distribution, site inventory, etc.) Support quality assurance prior to, during and after sponsor and site audits including assisting with corrective actions, remediation and follow up Work with the Clinical Project Manager and/or Clinical Study Manager to organize data and present study metrics to study team, medical monitor or DSMB related bodies Managed Vendor relations with the site

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, and event term relevant lab data. Site correspondence includes monitor duties such as phone calls, email correspondence, query resolution, and report clarifications. Project management duties include protocol mailbox monitoring, case intake supervision, reconciliations, SMP (safety management plan) updates, query tracking, closing endpoints by assisting adjudication team, report quality control, Argus and ARISg database process, regulatory report generation/submissions of MedWatch and CIOMS reports, due diligence for any outstanding queries, and the archiving of electronic trial master files (eTMF).• 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 correspondence, SMP familiarization, updates for SAEs and queries, mailbox monitoring, correspondence with sponsors, and trial master file (TMF)/eTMF archiving. Ensure all report timelines are met, and report all endpoints to clients, regulatory authorities, ethics committees, investigators, and any applicable project personnel.• 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 meeting minutes, assist my team in completion of tasks to meet department goals.

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).