Sara Richards

About Sara Richards

I am a GCP-trained clinical research professional with 4+ years of experience supporting industry-sponsored clinical trials. Currently, I am a Regulatory & Start Up Specialist at IQVIA, reviewing Informed Consent Forms (ICF) and Regulatory Documents, completing tracking and filing, and providing local expertise to various departments as necessary during initial and on-going project timeline planning. Prior to my current role, I was a Site Activation Specialist at IQVIA for 2+ years, specifically reviewing Informed Consent Forms (ICF) and Essential Documents Packs (EDP).I began my clinical research career as a Clinical Trials Associate I & II at IQVIA. I worked in Study Start-Up, Maintenance, and Feasibility in the therapeutic areas of two Oncology studies and one Pediatric Dermatology study. Preceding that, I worked at a pharmaceutical company, selling and distributing drugs for research and laboratory use.In 2020, I obtained my bachelor\'s degree in Biology from the University of Nevada, Reno.I am a personable, adaptable, detail-oriented, and dependable professional with an interest in healthcare, research, and scientific discovery. I am motivated to work both independently without supervision and as part of a team – driven to contribute a growth mindset, teamwork, and a high level of organization.

Experience

1. Regulatory & Start up Specialist

   IQVIA

   Sep 2025 — Present · US

   Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.• Prepare site regulatory documents, reviewing for completeness and accuracy.• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.• Review and provide feedback to management on site performance metrics.• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.• Inform team members of completion of regulatory and contractual documents for individual sites.• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.• Perform quality control of documents provided by sites.• May have direct contact with sponsors on specific initiatives.

Education

• Universidad del País Vasco/Euskal Herriko Unibertsitatea

  Spanish Language and Literature

  2019 — 2019

• University of Nevada-Reno

  Bachelor of Science - BS

  2016 — 2020