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Senior Clinical Research Associate résumé example

Senior Clinical Research Associate résumé example — senior, written for United States, set in the Clarity design
Senior Clinical Research Associate résumé example, in the Clarity design

Ten years from study coordinator to senior monitor, measured as a sponsor measures: queries, findings, days to first patient.

Written for United States, at senior, in the healthcare field, shown in the Clarity design. Every name, employer, address and number below is invented.

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Bethany Kohl — Senior Clinical Research Associate

Philadelphia, PA

Clinical research professional with ten years in oncology and cardiology trials, the last five monitoring sites for a mid-size CRO. Rewrote the source-document worksheet sites complete at each visit, which took the query rate per subject from 4.8 to 1.6 across 14 sites.

Experience

Senior Clinical Research Associate, Ardenway Clinical Research · January 2022 – present

Monitors 14 oncology sites on a phase III trial of 620 patients, at 18 to 20 on-site visits a quarter.

  • Closed 213 monitoring findings across 14 sites at a mean 9 days to resolution, against a study target of 21.
  • Caught a consent version error at three sites within two weeks of activation; re-consenting 46 patients kept the study clear of a reportable deviation.
  • Rewrote the source-document worksheet used at every visit, taking the query rate per subject from 4.8 to 1.6.
  • Led the site readiness work that shortened first-patient-in from 94 days to 58 across the last six activations.
  • Mentors five CRAs through co-monitoring visits; all five reached independent sign-off inside 7 months against a CRO average of 11.

Clinical Research Associate II, Lowell Pike Therapeutics · March 2019 – December 2021

Sponsor-side monitoring on two phase II cardiology studies.

  • Managed nine sites and escalated four enrollment shortfalls early enough to move the targets to sites that could fill them, protecting the database lock date.
  • Rebuilt the monitoring visit report template, which cut the sponsor review cycle from 12 days to 4.
  • Hosted an FDA bioresearch monitoring inspection at the highest-enrolling site, closing with no Form 483 observations.

Clinical Research Coordinator, Rittenhouse Oncology Institute · August 2016 – February 2019

  • Coordinated 11 oncology trials with 60 to 70 active patients, covering consent, visit scheduling and specimen handling.
  • Raised screening-to-enrollment conversion from 38% to 61% by pre-screening the tumor board list the week before clinic.
  • Kept regulatory binders for 11 studies inspection-ready through two sponsor audits, which returned three minor findings between them.

Education

  • M.S. Clinical Research Organization and Management · Drexel University · September 2019 – June 2021
  • B.S. Biology · Rutgers University · September 2012 – May 2016

Skills

  • Monitoring: Risk-based monitoring, Source data verification, Site initiation and close-out, Protocol deviation management, Informed consent review, Co-monitoring and mentoring
  • Regulatory: ICH-GCP, 21 CFR Part 11, IRB submissions, Trial master file review, SAE and SUSAR reporting, Inspection readiness
  • Systems: Medidata Rave, Veeva Vault eTMF, CTMS, IRT and IWRS, ePRO platforms
  • Therapeutic areas: Solid tumor oncology, Hematology, Cardiology, Rare disease

Certifications

  • CCRA, Certified Clinical Research Associate — Association of Clinical Research Professionals
  • ICH-GCP E6(R3) and Human Subjects Protection — CITI Program
  • IATA Dangerous Goods, Category B biological specimens — International Air Transport Association
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