Sitero logo
Sitero

Advancing clinical research with a next-generation, technology-enabled delivery model.

Senior Clinical Research Associate

Research AnalystResearch AnalystFull TimeRemoteSeniorTeam 201-500H1B No SponsorCompany SiteLinkedIn

Location

Australia

Posted

141 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Clinical Research Associate

Sitero

• Primary point of contact for site personnel during life cycle of clinical trial. • Provides support to the Global Project Lead and CTM during project start up to ensure timely site selection and feasibility. • Assists with collection of essential documents from the site. • May assist with submission of central EC Applications, Local EC applications, RA applications and any other local regulatory applications/Approvals required. • Ability to identify protocol deviations and pharmacovigilance issues that might affect data accuracy or patient safety. • Conduct Site qualification, site initiation, routine site monitoring close out visits (remote and onsite), Central monitoring in compliance with study protocol and ICH-GCP. • Expert documentation of monitoring priorities/activities via site visit confirmation and follow up letters, monitoring visit reports, and any trial associated logs. • Oversees conduct trials by reviewing study data listings, vendor dashboards, and CTMS issues/actions documentation to identify trends, errors, and any potential breeches that can impact data integrity. • Ability to present essential function of CRA role in Bid Defenses, Investigator Meetings, and Sponsor Face to Face meetings. • Assists the Global Project Lead in identification of out-of-scope activities. • Basic understanding of assigned projects scope, milestones and budget and manages site level activities to ensure project deliverables are met. • Provides support to the CTM and Global project lead in negotiation of site budgets and contracts.

Job Requirements

  • At least three (3) years of independently monitoring drug trials experience with a Contract Research Organization
  • 5 + Years of experience independently monitoring drug trials required
  • Bachelor's degree or higher education in a science related field required
  • Previous Contract Research Organization or Pharma experience required
  • CNS (Central Nervous System) therapeutic alignment experience is highly preferred

Benefits

  • Competitive salary
  • Variable pay
  • paid time off
  • healthcare benefits
  • retirement benefits

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