Sasha Studebaker

Key Responsibilities

• Supported the clinical operation team during study start-up, maintenance, and closure
• Reviewed PSV reports and made site selection recommendations
• Developed onboarding process for new hire CTAs
• Mentor new hire CTAs during their onboarding
• Lead CTA on a Phase Ib/II NSCLC global trial with 60+ sites
• Assisted with preparation, maintenance and close-out of the Trial Master Files (eTMF) for one or more studies
• Reviewed study start-up plans
• Documented findings and trends identified during routine reviews of the eTMF and communicated/escalated to the applicable project team members for resolution.
• Performed multiple rounds of UAT for IRT systems for multiple studies

Theraputic Area Experience

First in Human Solid Tumor, Phase I

Non-Small Cell Lung Cancer, Phase Ib, II

Key Responsibilities

• Adhered to Good Clinical Practices and specific study protocols
• Ensured scientific integrity of data and protected the rights, safety, and well-being of patients enrolled in clinical trials
• Recruited and coordinated the trial subjects covering informed consent, screening and inclusion of the subjects, adhering to safety and compliance issues
• Coordinated and managed the clinical trial through direct communication with the sponsor and other authorities, visit coordination, biological sampling, time management and product accountability.
• Collected and managed data utilizing source documents and case report forms, registered and managed AEs and SAEs, filed and archived various study documents, managed monitoring visits
• Close-out of the clinical trial, audit preparation, assisted in the final study report.

Therapeutic Area Experience

• Multiple Personality Disorder, Phases II, III
• Major Depressive Disorder Phases II, III
• Binge Eating Disorder, Phase III
• Pediatric Bipolar/Schizophrenia Phase II, III

Key Responsibilities

• Supported Coordinators in preparing for upcoming visits including scheduling and document creation.
• Responded to all data queries in a timely manner.
• Performed a variety of tests including laboratory/phlebotomy, vital signs, ECGs, as well as other needs as outlined in the study protocol(s).
• Obtained medical records.
• Responds to patient inquires via phone or in person in a timely manner.
• Processed and shipped samples collected as outlined in the study protocol(s).

Therapeutic Area Experience

• Nonalcoholic Fatty Liver Disease, Phase II, III

• Promoted physical and mental health of each animal with regular contact and treatment.
• Identify injuries through animal examinations and observations.
• Developed solid relationships with customers.
• Monitored animals for abnormal behaviors and potential injuries.
• Kept records of customer interactions or transactions, recording details of inquiries, complaints, or comments, as well as actions taken.
• Checked to ensure that appropriate changes were made to resolve customers' problems.
• Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
• Small business owner

• Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.
• Promoted professional growth and facilitated talent development of each associate to drive performance excellence.
• Maintained records related to sales
• Conducted research, compiled data, and prepared papers for consideration and presentation by executives.
• Assessed job applications and made hiring recommendations to bring in top candidates for key vacancies.
• Prepared sales slips or sales contracts.

• Answered owner animal health questions and advised on best care practices.
• Collected patient biopsies and blood samples for laboratory analysis.
• Assisted senior staff with blood analyses and physical assessments.
• Administered medications to animals in treatment and documented changes in condition.