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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 are committed to supporting your career journey in an innovative, collaborative, dynamic, and evolving environment. As an award-winning, customer-focused full-service clinical research organization, we leverage your strengths while promoting a healthy work-life balance.

We are seeking top performers who share our passion for clinical research—whether you're a seasoned clinical trial veteran or an industry newcomer ready to make an impact. Here’s your chance to play a crucial role in a rapidly expanding global company within the clinical research sector.

Your Role:

  • Site Visits: Schedule, plan, and conduct various site visits, including Site Selection, Initiation, Interim Monitoring, and Close-out Visits.
  • Reporting: Write comprehensive reports and follow-up letters for all site visits.
  • Study Management: Oversee the progress of assigned studies by managing 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, and study-specific materials to clinical sites.
  • Inventory Management: Conduct inventory of investigational products and ensure proper return or destruction of unused items.
  • Investigator Meetings: Assist with preparations and attendance at Investigator Meetings for assigned studies.
  • Document Compliance: Review study documents to ensure compliance with protocols and ICH GCP guidelines; escalate any issues to project management.
  • 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 open communication with sites regarding project expectations.
  • Quality Assurance: Evaluate site practices to ensure adherence to regulations and participate in planning quality assurance activities.
  • Team Support: Assist the Clinical Trial Manager in clinical operations by managing 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 field.
  • Language Skills: Fluent in English (oral and written) and any applicable local business language.
  • Experience: Minimum of three years in monitoring, preferably with experience as a clinical research coordinator or similar role.
  • 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 global 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 possess the necessary experience and are eager to join an energetic, creative, 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 are committed to creating a diverse environment 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 uphold fair employment practices regarding citizenship and immigration status.

Join us in shaping the future of clinical research!