Amanda Mitchell Email & Phone Number

Ambler, Pa, Us

Plymouth Meeting, Pennsylvania, United States

• Work as primary point-of-contact with multiple stakeholders including pharmaceutical grantors, academic site staff, and internal team members• Review and maintain regulatory eTMF for assigned studies according to GCP guidelines, federal regulations, and stakeholder contracts. • Review study budgets and disburse funding according to milestones set forth in research agreements. •Apply risk-based communication plan with research investigators in staying on track for study and… Show more • Work as primary point-of-contact with multiple stakeholders including pharmaceutical grantors, academic site staff, and internal team members• Review and maintain regulatory eTMF for assigned studies according to GCP guidelines, federal regulations, and stakeholder contracts. • Review study budgets and disburse funding according to milestones set forth in research agreements. •Apply risk-based communication plan with research investigators in staying on track for study and deliverable timelines.• Collect, review and reconcile quarterly reports from research investigators; Collate completed quarterly study information and provide to appropriate pharmaceutical grantors. • Review all SAE’s and ensure all required information is obtained for pharmaceutical grantors and internal requirements. • Led development and primary author of two new SOP’s• Acted as a system administrator for team’s clinical research management software Show less

• Extract data from electronic medical records (EMR) and paper source into EDC for up to seven phase one oncology trials simultaneously. • Complete electronic case report forms (eCRFs) for patients assigned in clinical trials. • Complete all query resolution and data reconciliation for assigned clinical trial studies. • Schedule monitoring visits (IMVs) for assigned studies and act as main point-of-contact for study monitors. • Collaborate with CRAs and data managers to ensure… Show more • Extract data from electronic medical records (EMR) and paper source into EDC for up to seven phase one oncology trials simultaneously. • Complete electronic case report forms (eCRFs) for patients assigned in clinical trials. • Complete all query resolution and data reconciliation for assigned clinical trial studies. • Schedule monitoring visits (IMVs) for assigned studies and act as main point-of-contact for study monitors. • Collaborate with CRAs and data managers to ensure clinical trial data is data-lock and audit ready. • Communicate with external vendors to ensure they receive all necessary ECG’s and blood samples. • Identify and properly document protocol deviations and non-compliance on supported trials. • Independently completed Office of Clinical Research archived study inventory and built excel directory of archived studies for office use. • Manage delegation logs, CAP and CLIA certifications, and create note-to-file’s (NTFs) to support regulatory work. • Independently identified bug in OnCore Financial Events and escalated appropriately for improved documentation of research monitor changes and IMVs. • Upkeep CTMS with patient visits, protocol deviations, and data throughout phase one oncology clinical trials in accordance to Good Clinical Practice (GCP) and HIPAA standards. • Trained new team members in data extraction and query resolution. • Perform all work-related tasks in compliance with ICH-GCP and HIPAA requirements. Show less

Chestnut Hill, Massachusetts, United States

• Transformed DNA into cancer cells and immortalized cells for studying proteins implicated in cancer and other human diseases.• Cultured bacteria under sterile conditions to avoid sample contamination.• Optimized research technique protocols to obtain accurate research results. • Purified and analyzed biological samples of interest.• Utilized PCR to amplify DNA samples for analysis.• Maintained inventory of biological samples. • Conducted independent reseearch in… Show more • Transformed DNA into cancer cells and immortalized cells for studying proteins implicated in cancer and other human diseases.• Cultured bacteria under sterile conditions to avoid sample contamination.• Optimized research technique protocols to obtain accurate research results. • Purified and analyzed biological samples of interest.• Utilized PCR to amplify DNA samples for analysis.• Maintained inventory of biological samples. • Conducted independent reseearch in development of novel FRET pairs utilized in biological research. • Interpreted and analyzed research data to draw conclusions on outcomes. • Collaborated with 8+ academic colleagues on areas of shared research interest and research techniques. • Wrote and edited experimental results for publication. • Performed supply management to maintain stock and inventory of laboratory supplies. • Followed standard operating procedures (SOPs) on for all processes to ensure safety and accuracy when carrying out work. Show less

• Demonstrated skills and safety procedures for up to 16 students per class during laboratory sessions. • Observed students to assess progress with laboratory work and assigned grades. • Graded quizzes, tests, homework, and projects for providing feedback to students.• Guided pre-medical students in understanding the relationships between scientific concepts, medicine, and healthcare. • Led one-on-one, small group, and large lecture hall study sessions of 50+ students in… Show more • Demonstrated skills and safety procedures for up to 16 students per class during laboratory sessions. • Observed students to assess progress with laboratory work and assigned grades. • Graded quizzes, tests, homework, and projects for providing feedback to students.• Guided pre-medical students in understanding the relationships between scientific concepts, medicine, and healthcare. • Led one-on-one, small group, and large lecture hall study sessions of 50+ students in preparation for science exams and medical school entrance exams. Show less

Master Of Science (M.S.), Chemistry

Bachelor Of Science (B.S.), Chemistry, Biology

Activities and Societies: Phi Beta Kappa