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Clinical Research Associate

2+ years
Not Disclosed
10 May 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

JOB DESCRIPTION

Organization: Fortrea

Position: Clinical Research Associate (CRA)


About Fortrea

Overview:

  • Leading global contract research organization (CRO).
  • Provides a wide range of clinical development, patient access, and technology solutions.
  • Specializes in more than 20 therapeutic areas.
  • Operates with over 19,000 staff in more than 90 countries.
  • Committed to transforming drug and device development for partners and patients globally.

Website: Fortrea


Summary of Responsibilities

  • Site Management: Manage clinical studies according to Fortrea’s SOPs, ICH GCP Guidelines, project plans, and Sponsor requirements.
  • Site Monitoring: Conduct site monitoring for clinical trials, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
  • Project Planning: Prepare and implement project plans related to Clinical Monitoring responsibilities.
  • Subject Protection: Verify adherence to informed consent procedures, protocol requirements, and regulatory requirements.
  • Data Integrity: Review and verify source documents, generate and resolve queries, ensuring data integrity against established guidelines.
  • Regulatory Compliance: Ensure Site Regulatory documents and eTMF/Sponsor Documents are complete and current.
  • Investigational Product Management: Ensure accurate inventory and accountability of study materials, secure storage per protocol.
  • Quality Control: Adhere to global quality control and CRA performance metrics.
  • Audit Readiness: Ensure sites are audit-ready.
  • Leadership: Act as Lead CRA as assigned.

Qualifications

Education:

  • University or college degree, or certification in a related allied health profession (e.g., nursing licensure) from an accredited institution.
  • Equivalent experience may be substituted as appropriate.

Knowledge:

  • Thorough understanding of ICH GCP Guidelines and local regulatory requirements.

Experience

  • Minimum of 2 years of Clinical Monitoring experience.

Fortrea’s Commitment

Fortrea seeks motivated problem-solvers and creative thinkers to revolutionize the clinical trial development process. We are dedicated to delivering life-changing ideas and therapies swiftly to patients in need. Join our team and embrace a collaborative environment that nurtures personal growth and enables a meaningful global impact.


Equal Opportunity Statement

Fortrea is an Equal Opportunity Employer (EOE/AA), striving for diversity and inclusion. We do not tolerate harassment or discrimination of any kind and make employment decisions based on business needs and individual qualifications without regard to:

  • Race
  • Religion
  • Color
  • National origin
  • Gender (including pregnancy or other medical conditions/needs)
  • Family or parental status
  • Marital, civil union, or domestic partnership status
  • Sexual orientation
  • Gender identity
  • Gender expression
  • Personal appearance
  • Age
  • Veteran status
  • Disability
  • Genetic information
  • Any other legally protected characteristic

Encouragement: We encourage all to apply.

For more information, visit Fortrea.