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Senior Clinical Research Associate Contractor

Biorasi
Biorasi
3+ years
Not Disclosed
10 Dec. 24, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Clinical Research Associate (CRA)
Company: Biorasi


About Biorasi
Biorasi is a customer-focused, full-service clinical research organization committed to innovation, collaboration, and evolution. We aim to provide a dynamic work environment that supports your career growth while promoting work-life balance. Be part of a global team passionate about bringing life-changing therapies to patients.


Your Role

As a Clinical Research Associate (CRA), you will be responsible for ensuring the effective execution of clinical trials while maintaining compliance with regulatory requirements and study protocols. Your key responsibilities include:

  • Site Visits and Monitoring:
    • Schedule, plan, and conduct Site Selection, Site Initiation, Interim Monitoring, and Close-out Visits.
    • Prepare detailed reports and investigator follow-up letters for site visits.
  • Study Progress Management:
    • Track regulatory/IRB submissions, enrollment progress, CRF submissions, and data query resolutions.
    • Provide updates to project management teams.
  • Study Support Activities:
    • Organize the delivery and inventory of investigational products and study materials.
    • Assist with Investigator Meetings and protocol-related training.
  • Regulatory Compliance:
    • Review study documents for adherence to protocol, ICH GCP guidelines, and regulatory requirements.
    • Escalate site issues to project management as needed.
  • Essential Documentation:
    • Collect and review essential documents for eTMF filing.
    • Evaluate site practices for quality and compliance.
  • Team Collaboration:
    • Assist Clinical Trial Managers in resource allocation, performance reviews, and site visit report oversight.
    • Participate in team meetings and provide feedback for overall study performance analysis.
  • Leadership and Mentorship:
    • Mentor team members in job performance and professional growth.
    • Conduct on-site evaluations and training for CRAs.
  • Additional Duties:
    • Perform investigational product inventory and manage return or destruction.
    • Support quality assurance activities and resolve audit findings.

Your Profile

  • Education and Experience:
    • Bachelor’s degree in biomedical sciences or a related field.
    • Minimum 3 years of monitoring experience (more preferred), with a background in clinical research coordination or similar roles.
  • Skills and Knowledge:
    • Proficiency in clinical monitoring processes and medical terminology.
    • Familiarity with ICH GCP guidelines and global regulatory requirements.
    • Strong leadership, planning, and communication skills (verbal and written).
    • Advanced knowledge of MS Office Suite (Word, PowerPoint, Excel).
  • Other Requirements:
    • Fluent in English (oral and written) and applicable local business language.
    • Ability to travel up to 70%, depending on project needs.

Why Join Biorasi?

We offer competitive benefits designed to support you and your family, including:

  • Half-day Fridays.
  • Paid time off and holidays.
  • Comprehensive country-specific benefits.
  • Employee bonus programs.
  • Career growth, training, and development opportunities.

Apply Now

If you meet the qualifications and are excited to join a passionate, collaborative team, apply at our Careers Page or email us at careers@biorasi.com.


Diversity and Inclusion

Biorasi is an equal-opportunity employer committed to fostering diversity and inclusion. We welcome applicants of all backgrounds and comply with fair employment practices regarding citizenship and immigration status.