Clinical Research Associate

4 weeks ago

Dubai, United Arab Emirates Actalent Full time

Description:

  • Performs site qualification,initiation, interim and close-out monitoringvisits.
  • This role ensures compliance withclinical trial protocols andregulations.
  • Conducts monitoring visits atsites to perform source data verification and study file(regulatory) review and addresses identified issues directly withsite staff.
  • Manages complex issues with minimalsupport.
  • Analyzes trends in identified issuesand write visit follow-up reports with minimal oversight andguidance. For sites with systemic issues identified, performs rootcause analysis, and implement corrective and preventativeactions.
  • Communicates with sites to effectivelyresolve issues. Provides clear and technically accurateinformation, both orally and inwriting.
  • Participates in training junior CRAson moderately complex concepts, processes, andtasks.
  • Manages moderately complex projects asassigned under the direction of the Clinical ProjectManager.
  • Creates and/or contributes to thedevelopment of monitoring/audit tools and materials (e.g.,project-specific work instructions, training materials,newsletters)
  • May participate in the developmentof study protocols, case report forms, and clinical monitoring planand provides expert input.
  • Authors and reviewsdrafts of project-specific forms instruction manuals/CRF completionguidelines.
  • Other duties asassigned.

Additional Skills& Qualifications:

  • Clinical research study processes,study design and/or protocolmanagement.
  • Clinical trial monitoringprocedures and clinical data reportingprocesses.
  • ICH GCP guidance and FDAregulations.
  • Medical terminology andanatomy/physiology.
  • Microsoft Suite of softwareproducts.
  • Intermediate project management,training, and conflict resolutionskills.
  • Perform tasks requiring excellentattention to detail.
  • Manage multiple deadlinesand priorities while ensuring quality andtimeliness.
  • Work effectively and efficiently ina remote environment.
  • Travel up to 70% of time(domestic and international).

AboutActalent

Actalent is a globalleader in engineering and sciences services and talent solutions.We help visionary companies advance their engineering and scienceinitiatives through access to specialized experts who drive scale,innovation and speed to market. With a network of almost 30,000consultants and more than 4,500 clients across the U.S., Canada,Asia and Europe, Actalent serves many of the Fortune500.

Diversity, Equity &Inclusion

At Actalent,diversity and inclusion are a bridge towards the equity and successof our people. DE&I are embedded into our culturethrough:

  • Hiring diversetalent
  • Maintaining an inclusive environmentthrough persistent self-reflection
  • Building aculture of care, engagement, and recognition with clearoutcomes
  • Ensuring growth opportunities for ourpeople

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