Susan Farrow Email & Phone Number

Managed, implemented, and monitored clinical studies, by independently and proactively identifying, training / initiating, and closing out study sites. Managed 35 sites simultaneously across Phase 3 Oncology, Medical Device, and Pediatric Pulmonology trials from study start-up through study management.• Conducted monthly or biweekly site contact meetings and remote site monitoring visits per Monitoring Plan. Performed CRA responsibilities as required.• Acted as main point of contact for all study needs including site initiation, monitoring, close-out, SDV, SDR, regulatory file review and document filing, action item resolution, site personnel training, audit preparation, and IRB submissions.• Onboarded up to 5 lesser experienced colleagues on general site management duties, EDC systems, TMF systems, and study-specific onboarding. • Developed, recorded, and promoted 16 training tutorials for specific EDC system for 40-50 study sites driving higher levels of standard use of system and reducing errors.• Partnered with Clinical Trial Manager to create Monitoring Plan and Site Initiation Visit (SIV) slide deck. Proactively reviewed site and patient payment invoices to enable quicker, more efficient reconciliation.• As site management SME, invited to participate in weekly virtual and face-to-face sponsor meetings for updates on project status.

Reporting to the Clinical Operations Manager and working with Clinical Trial Managers, identified, selected, initiated, and closed-out investigational sites for clinical studies. Managed up to 25 sites simultaneously across Phase 1-4 Infectious Disease, Medical Device, and Vaccine trials from study start-up through study close-out.• Monitored clinical trial sites driving compliance to study protocols, SOPs, ICH-GCP principles, and regulatory requirements.• Worked closely with principal investigator, and other research team members, reviewed site activities and subject records, including participant enrollment, informed consent, data entry, adverse events, IRB and protocol compliance, protocol deviations, and regulatory documentation.• Routinely and independently completed at minimum 10 days on-site per month, maintained at least 95% compliance with TMF completeness and accuracy, ensured action items were resolved within 8 weeks of identification, and 100% of visit reports completed within 5 days of visit.• Ran reports from EDC and eTMF for clinical trial protocols before site visits to ensure compliance with document filing, data completion, and query resolution. Liaised with site personnel to secure missing documentation and ensure timely data entry and query resolution. • Recipient of multiple company Inspire Awards in recognition of work excellence.• Outperformed CRA metric regarding Days on Site (DOS).

Brentwood, Tennessee

Reporting to the Clinical Operations Manager and working with Clinical Trial Managers, identified, selected, initiated, and closed-out investigational sites for clinical studies. Managed up to 25 sites simultaneously across Phase 1-4 Infectious Disease, Medical Device, and Vaccine trials from study start-up through study close-out.• Monitored clinical trial sites driving compliance to study protocols, SOPs, ICH-GCP principles, and regulatory requirements.• Worked closely with principal investigator, and other research team members, reviewed site activities and subject records, including participant enrollment, informed consent, data entry, adverse events, IRB and protocol compliance, protocol deviations, and regulatory documentation.• Routinely and independently completed at minimum 10 days on-site per month, maintained at least 95% compliance with TMF completeness and accuracy, ensured action items were resolved within 8 weeks of identification, and 100% of visit reports completed within 5 days of visit.• Ran reports from EDC and eTMF for clinical trial protocols before site visits to ensure compliance with document filing, data completion, and query resolution. Liaised with site personnel to secure missing documentation and ensure timely data entry and query resolution. • Recipient of multiple company Inspire Awards in recognition of work excellence.• Outperformed CRA metric regarding Days on Site (DOS).

Brentwood, Tennessee

Provided administrative and project tracking support to the Project Managers and Clinical Trial Managers for 4 gastroenterology studies. Set up, organized, and maintained electronic Trial Master Files. • Project -tracked and maintained Clinical Trial Management System (CTMS). • Processed and tracked protocol deviations through weekly report creation for CRAs.• Generated 9 weekly study status reports from EDC, TMF, CTMS, and sponsor systems for study team review.• Created, edited, and organized complex Microsoft Excel data for study team use.• Coordinated, dispatched, and tracked study materials.• Generated study communications including meeting minutes and acted as primary point of contact for study team for administrative issues, requests, or queries.

Nashville, Tennessee

Mentored and trained new employees on extraction methods and laboratory instrument operation. Performed dilute and shoot, LLE, and SPE extraction techniques on samples in preparation to run on mass spectrometers for drug analysis. Operated wide range of laboratory instruments, and monitored and maintained quality of samples, batches, reagents, and chemicals. Performed sample and batch preparation and analysis.• Consistent high achiever as Forensic Processing Technician and Special Chemist delivering 150-180% batch completion monthly.

Nashville, Tn

Led and trained 5 employees on work protocols and acted as a point of contact for troubleshooting and problem resolution. Received and accessioned samples, maintained integrity of chain of custody, and prepared samples for further processing. Compiled work reports and submitted daily updates.

Frederick, Md

Received, handled, and inventoried specimens of human, animal, and plant origin at temperatures ranging from ambient to -180°C. Followed SOPs, maintained up-to-date documentation, and updated data files.

Rockville, Md

Provided navigational support and information services for the Nationwide Mortgage Licensing System (NMLS) website to current and aspiring Mortgage Loan Originators (MLOs) at FINRA’s NMLS Call Center. Assisted Mortgage Lending Officers (MLOs) nationwide to perform yearly renewal of licensing.