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Senior Clinical Research Associate

3 months ago

Tampa, United States Meet Full time

Meet has partnered with a highly innovative oncology biotech that is seeking a Senior Clinical Research Associate to join the team In collaboration with the Head of Clinical Operations, the Sr CRA will manage clinical studies, with a focus on adherence to critical timelines, site training and support, vendor management, high-caliber document development and quality data collection. The Sr CRA will oversee and support site operations and will manage field study monitors’

activities in accordance with the trial-specific monitoring plan. The applicant should

possess strong critical thinking skills and the ability to comprehend technical subject

matter to effectively support sites and contribute to the organization. Oncology experience

is a must and frequent travel to study sites is expected.


Responsibilities:

  • Serves as a point of contact between CRO, vendors, clinical site personnel and the team
  • Support the management of the daily operations of clinical research studies to ensure
  • timely start-up, accrual, maintenance and close-out of assigned studies
  • Contributes to content generation, writing and editing of study protocols, amendments,
  • informed consents, committee charters, study reports, study plans and manuals, CRFs
  • and other related clinical and regulatory documents
  • Oversees and supports CRO and field monitors with monitoring related items and
  • follow-up on study tasks
  • Tracks specimens and radiology images going to central laboratories
  • Performs other tasks as directed by line management or project leadership


Qualifications:

  • BA/BS degree, preferably in scientific or healthcare related field. CRA certification desired
  • At least 5 years of experience in clinical research, with at least 3 years as a CRA
  • Oncology experience required
  • Ability to travel 40-50% of the time (domestic). Possible international travel
  • Expert knowledge of FDA regulations, ICH guidelines, GCP principles, and other
  • standards related to clinical trials
  • Strong attention to detail


Please reach out to Marina Menchero at marina@peoplewithchemistry.com if you'd like to learn more about this opportunity. This will be a fully confidential conversation.