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Clinical Research Associate, Senior

5+ years
Not Disclosed
10 Nov. 27, 2024
Job Description
Job Type: Full Time Remote 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 Title: Senior Clinical Research Associate (Sr. CRA)
Job Family: Clinical Research Associate
Location: Remote (site travel as needed)


Position Summary

The Senior Clinical Research Associate (Sr. CRA) plays a key role in managing complex site activities, mentoring junior CRAs, and ensuring the successful conduct of clinical studies. This position involves advanced responsibilities in site management, regulatory compliance, and quality monitoring. The Sr. CRA also contributes to process improvements, audit preparations, and the development of study-specific materials.


Key Responsibilities

  • Oversee site monitoring activities for complex clinical studies, ensuring high-quality deliverables and adherence to regulatory requirements.
  • Mentor and support junior CRAs in best practices for site management and monitoring.
  • Collaborate in the creation and review of study plans, forms, tools, and site training materials.
  • Prepare comprehensive monitoring reports and documentation with minimal oversight.
  • Provide strategic insights to study teams to improve processes and enhance study efficiency.
  • Facilitate audit preparations, monitor data quality, and resolve protocol deviations.
  • Act as a subject matter expert, offering guidance on critical clinical study management issues.

Qualifications

Required Qualifications

  • Education: Bachelor’s degree in life sciences, biomedical sciences, or a related field with a strong understanding of oncology terminology and clinical practices.
  • Experience:
    • Minimum of 5 years in clinical research monitoring.
    • At least 1 year of CRA experience at LumaBridge preferred.
  • Leadership: Proven track record in mentoring and guiding junior CRAs.
  • Regulatory Knowledge: Advanced understanding of ICH-GCP, FDA regulations, and clinical study standards.
  • Communication Skills: Exceptional verbal and written communication skills, with the ability to present complex information clearly.
  • Technical Proficiency: Advanced proficiency in Microsoft Office Suite, EDC, and CTMS applications.

Preferred Qualifications

  • Oncology Expertise: Early-phase oncology experience is highly preferred.
  • Process Improvement: Experience in identifying and implementing process improvements within clinical monitoring.
  • Audit Management: Familiarity with audit processes, including preparation and follow-up activities.

Why Join Us?

We are an equal-opportunity employer committed to fostering an inclusive and diverse workplace. Our team celebrates diversity and mutual respect, encouraging applicants from all backgrounds to apply.

Accessibility & Accommodation:
We are dedicated to providing equal opportunity and reasonable accommodations for individuals with disabilities. If you require any adjustments during the application or interview process, please contact our HR department at hrapplicants@lumabridge.com.


Disclaimer:
This job description outlines the general scope of responsibilities and qualifications for the role. Additional duties may be assigned, and responsibilities may evolve based on organizational needs.