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Senior Clinical Research Associate Contractor

3+ years
Not Disclosed
10 Nov. 26, 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

Join the Biorasi Team! Clinical Research Associate (CRA) Opportunity

At Biorasi, we are growing fast and looking for talented individuals who are passionate about clinical research. Whether you're an experienced clinical trial professional or just starting your career, we offer a collaborative, innovative, and dynamic environment where you can thrive. Biorasi is an award-winning, full-service Clinical Research Organization (CRO), committed to providing high-quality services and driving new therapies to patients globally.

Your Role as a Clinical Research Associate (CRA)

As a CRA at Biorasi, your responsibilities will include:

  • Site Visits:

    • Schedule, plan, and conduct various site visits, including Site Selection, Site Initiation, Interim Monitoring, and Site Close-out Visits.
    • Write Reports and Investigator Follow-up Letters for each site visit type.
  • Study Management:

    • Track study progress through regulatory/IRB submissions, recruitment, CRF completion, and data query resolution.
    • Organize the delivery of investigational products, laboratory supplies, and other study materials to clinical sites.
    • Perform inventory checks for investigational products, ensuring proper returns or destruction of unused items.
  • Compliance & Training:

    • Review study documents for compliance with protocol, ICH GCP guidelines, and regulatory requirements.
    • Assist with investigator meetings and provide necessary study-specific training.
    • Administer ongoing protocol and regulatory training to clinical sites and ensure adherence to study conduct regulations.
  • Study Oversight:

    • Monitor the quality and integrity of study site practices, escalating issues as needed.
    • Assist the Clinical Trial Manager (CTM) with resource allocation, site performance reviews, and feedback to CRAs and CTAs.
    • Participate in team meetings and teleconferences, and assist with reporting site performance on timelines and deliverables.
  • Travel Requirement:

    • This role requires up to 70% travel to different clinical sites depending on project needs.

Your Profile

To be successful in this role, you should have:

  • Education: A Bachelor’s Degree in biomedical sciences or a related scientific discipline.
  • Experience: A minimum of three years in clinical monitoring, with a combination of clinical research coordinator experience or other relevant clinical research roles.
  • Knowledge & Skills:
    • Strong understanding of medical terminology, clinical monitoring processes, and ICH GCP.
    • Ability to work with MS Office suite (Word, PowerPoint, Excel).
    • Leadership, planning, project management, and communication skills.
    • Ability to travel up to 70% based on project requirements.

Why Work with Biorasi?

  • Innovative & Collaborative Environment: Join a growing global company with a focus on innovative research and therapeutic breakthroughs.
  • Work-Life Balance: Enjoy benefits like half-day Fridays, paid time off, and paid holidays.
  • Competitive Benefits: We offer medical, dental, vision, and life insurance along with a company-matching 401(k), employee bonus programs, and career development opportunities.

How to Apply

If you meet the above qualifications and are ready to contribute to a dynamic team, apply directly through our website at Biorasi Careers or send your resume to careers@biorasi.com.

Equal Opportunity Employer

Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Join Biorasi and be part of shaping the future of clinical research!