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Senior Clinical Research Associate Contractor

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 believe in supporting your career journey the Biorasi way—through innovation, collaboration, and dynamic growth. 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 on the lookout for passionate individuals—both seasoned clinical trial veterans and industry newcomers—who thrive in a fast-paced environment and are committed to advancing new therapies for patients. This is your opportunity to become an integral part of a rapidly expanding global company in the clinical research industry.

Your Role:

  • Site Visits: Schedule, plan, and conduct various site visits, including Site Selection, Initiation, Interim Monitoring, and Close-out Visits.
  • Reporting: Write reports and follow-up letters for all site visits.
  • Study Management: Track the progress of assigned studies by managing regulatory/IRB submissions, recruitment, CRF completion, and data queries.
  • Project Updates: Provide regular updates to the project management team.
  • Logistics: Organize the delivery of investigational products, laboratory supplies, and study-specific materials to clinical sites.
  • Inventory Management: Perform inventory of investigational products and ensure the proper return or destruction of unused items.
  • Investigator Meetings: Assist in the preparation and attendance of Investigator Meetings for assigned studies.
  • Document Review: Ensure compliance with study protocols and ICH GCP guidelines by reviewing essential study documents.
  • Training: Administer protocol training to site staff and establish effective communication channels.
  • Quality Assurance: Evaluate site practices for compliance and participate in planning quality assurance activities.
  • Team Support: Assist the Clinical Trial Manager in clinical operations by overseeing resource allocation and providing performance feedback to CRAs and CTAs.
  • Mentorship: May serve as a mentor to junior associates regarding job performance and professional growth.
  • Additional Duties: Perform other responsibilities as assigned.

Your Profile:

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

If you meet these qualifications and are eager to join a creative, energetic, and collaborative team, please apply directly on our website at Biorasi Careers or email us at careers@biorasi.com.

Our Commitment:

Biorasi is dedicated to enhancing the health and well-being of our employees and their families through thoughtfully designed benefits. We value diversity and are proud to be an equal opportunity employer. All qualified applicants will be considered 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 adhere to fair employment practices regarding citizenship and immigration status.

Join us and help shape the future of clinical research!