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Senior Clinical Research Associate Contractor, Italy

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) Position

At Biorasi, we are experiencing rapid growth, and we're looking for driven and passionate professionals to join our dynamic team. Whether you are a clinical trial veteran or new to the field, we welcome individuals who are excited to contribute to groundbreaking therapies and help improve patients' lives. Biorasi is a full-service, customer-focused, and award-winning Clinical Research Organization (CRO) committed to innovative solutions, work-life balance, and collaborative growth.

Your Role as a Clinical Research Associate (CRA)

As a Clinical Research Associate (CRA) at Biorasi, your key responsibilities will include:

  • Site Visits:

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

    • Track study progress, including regulatory/IRB submissions, enrollment, CRF completion, and data query resolution.
    • Organize the timely delivery of investigational products, laboratory supplies, CRFs, and other materials to clinical sites.
    • Oversee investigational product inventory, ensuring appropriate returns or destruction.
  • Compliance and Training:

    • Review study documents for compliance with protocols, ICH GCP guidelines, and regulatory standards.
    • Assist with investigator meetings, provide training on protocols, and ensure regular communication with sites.
  • Site Oversight:

    • Monitor site practices to ensure study integrity and adherence to regulations.
    • Work closely with the Clinical Trial Manager (CTM) to assist with resource allocation, site performance reviews, and issue resolution.
  • Collaboration:

    • Participate in regular team meetings and teleconferences.
    • Mentor and support associates in their professional growth.
    • Report on site performance, timelines, and study deliverables to the project management team.

Your Profile

To succeed in this role, you should have:

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

Why Biorasi?

  • Innovative & Collaborative Environment: Be part of a growing, award-winning CRO focused on new therapies and clinical excellence.
  • Work-Life Balance: Enjoy half-day Fridays, paid time off, paid holidays, and a supportive work environment.
  • Competitive Benefits: We offer medical, dental, vision, and life insurance, along with employee bonus programs, 401(k) matching, and ample career development opportunities.

How to Apply

If you meet the qualifications and want to be a part of a creative, fast-paced, and collaborative team, apply today through our website at Biorasi Careers or send your resume to careers@biorasi.com.

Equal Opportunity Employer

Biorasi 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.

Become part of the Biorasi family and help shape the future of clinical research!