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Senior Clinical Research Associate Contractor, Germany

3+ years
Not Disclosed
10 Sept. 30, 2024
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Our Growing Team at Biorasi!

At Biorasi, we’re committed to supporting your career journey in an innovative, collaborative, and dynamic environment. As an award-winning, customer-focused full-service clinical research organization, we capitalize on your strengths while promoting a healthy work-life balance.

We are looking for top performers who share our passion for clinical research—whether you are a seasoned clinical trial veteran or an enthusiastic newcomer ready to make a difference. This is your opportunity to be a vital part of a rapidly expanding global company in the clinical research industry.

Your Role:

  • Site Visits: Schedule, plan, and conduct Site Selection, Initiation, Interim Monitoring, and Close-out Visits.
  • Reporting: Prepare detailed reports and follow-up letters for all site visits.
  • Study Management: Track the progress of assigned studies, including regulatory/IRB submissions, recruitment, CRF completion, and data query resolution.
  • Project Updates: Provide timely updates to the project management team.
  • Logistics Coordination: Organize the delivery of investigational products, laboratory supplies, CRFs, and other study-specific materials to clinical sites.
  • Inventory Management: Conduct inventory of investigational products, ensuring proper return or destruction of unused items.
  • Investigator Meetings: Assist in preparing for and attending Investigator Meetings for assigned studies.
  • Document Compliance: Review study documents for compliance with protocols and ICH GCP guidelines, escalating issues to project management as necessary.
  • Essential Document Collection: Gather and review essential study documents for filing in the electronic Trial Master File (eTMF).
  • Training Administration: Provide protocol training to site staff and maintain regular communication to manage project expectations.
  • Quality Assurance: Evaluate site practices to ensure compliance with regulations and participate in quality assurance activities.
  • Team Support: Assist the Clinical Trial Manager by overseeing resource allocation, reviewing site performance, and providing feedback to CRAs and CTAs.
  • Mentorship: May serve as a mentor to junior associates on job performance and professional growth.
  • Additional Responsibilities: Perform other duties as assigned.

Your Profile:

  • Education: Bachelor’s degree in biomedical sciences or a related scientific discipline.
  • Language Skills: Fluent in English (oral and written) and any applicable local business language.
  • Experience: Minimum of three years in monitoring, with a background in clinical research coordination preferred.
  • Knowledge Base: Strong understanding of medical terminology and advanced proficiency in clinical monitoring processes.
  • Travel Requirement: Willingness to travel up to 70% based on project needs.
  • Regulatory Knowledge: Familiarity with ICH GCP and worldwide regulatory requirements.
  • Skills: Excellent leadership, planning, project management, and communication skills.
  • Technical Proficiency: Proficient in MS Office Suite, particularly Word, PowerPoint, and Excel.

If you meet these qualifications and want to be part of an energetic, creative, and collaborative team, please apply directly on our website at Biorasi Careers or email us at careers@biorasi.com.

Our Commitment to Diversity:

Biorasi is dedicated to fostering a diverse work 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. We also uphold fair employment practices concerning citizenship and immigration status.

Join us in shaping the future of clinical research!