Sarah Hopson

About Sarah Hopson

I am a former research scientist turned clinical research associate. I earned my PhD in…

Experience

1. Senior Clinical Research Associate Ii

   IQVIA

   Sep 2023 — Present

   Job Overview Perform monitoring and site management work for a variety of protocols, site and therapeutic areas. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator\'s Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Act as a mentor for clinical staff including conducting co-monitoring and training visits. • Collaborate and liaise with study team members for project execution support as appropriate.

Skills

• Dot Blot
• Protein Expression
• Protein Chemistry
• Yeast Transformation
• Maldi-Tof
• Dna Electrophoresis
• Bacterial Cell Culture
• Molecular Genetics
• Protein Chromatography
• Research
• Bacterial Transformation
• Isothermal Titration Calorimetry
• Dna Ligation
• Dna Quantification
• Molecular Cloning
• Basic Cell Biology
• Recombinant Protein Cloning: E. Coli and P. Pastoris
• Dna Manipulation
• Bca Protein Assay
• Yeast Cell Culture
• Chemistry
• Molecular & Cellular Biology
• Aseptic Technique
• Molecular Dynamics
• Protein Quantitation
• Transient Transfection
• Osha Regulations
• Chemical Inventory
• E. Coli
• University Teaching
• Site-Directed Mutagenesis
• Dna Extraction
• Genomic Dna Isolation
• Pcr
• Protein Characterization
• Fluorescence Anisotropy
• Molecular Biology
• Protein Production
• Western Blotting
• Dna Methylation Array Analysis