Lia Adderley

· Coordinating patient involvement from study start-up until study completion, ensuring adherence to protocol visit windows and timelines

· Maintaining a thorough knowledge of study-specific inclusion/exclusion criteria

· Conducting safety and efficacy assessments including blood draws, EKGs, and vitals

· Collecting, processing, and shipping lab samples

· Maintaining accurate source documents, managing data entry, and resolving queries promptly

· Prepare and maintain regulatory submissions (initial submissions, continuing reviews, amendments, and study closeouts)

· Assisting investigators with adverse event(AE) reporting and ensured compliance with GCP

· Manages study supplies, drug supplies, and drug accountability at site

· Supported site selection, initiation, monitoring, and close-out visits for over 30 studies

· Managed CRF completion, data query resolution, and biologic sample processing in compliance with federal regulations and guidelines

· Prepared and maintained IRB submissions for over 20 studies (initial submissions, continuing reviews, amendments, and study closeouts)

· Facilitated audits and monitoring visits with CROs to maintain trial compliance

· Overseeing the administration of protocol and study-related training to research staff

· Manages study supplies, IP supplies, and study device supplies

· Provided personalized recommendations and after-sales support to ensure client satisfaction and repeat business.

· Managed product displays and promotional materials for B2B events, leading to increased awareness of brand offerings among business clientele

· Provided dedicated B2B customer service, addressing specific needs and concerns of high-value clients.

· Collaborated with the merchandising team to create corporate-focused product displays and presentations

· Verify and load patients’ insurance information into the hospital system.

· Interview patients and family to obtain accurate demographic and financial information.

· Ensure that all questionnaires and forms are completed according to pre-determined requirements by government or regulatory agencies.