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Clinical Project Associate

2+ 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: Be Part of Our Growth!

At Biorasi, we are passionate about delivering new therapies to patients, and we are expanding our team to continue driving innovation in clinical research. Whether you’re an experienced professional or just starting your career in clinical trials, we offer an exciting and dynamic environment where you can thrive, learn, and grow.

As an award-winning, customer-focused, full-service clinical research organization, Biorasi values creativity, collaboration, and work-life balance. Join us and become a vital part of our global team that’s reshaping the clinical research industry.

Your Role:

  • Communication: Participate in meetings and teleconferences, develop agendas, minutes, and status reports, and track action items to document project updates and communicate them to relevant stakeholders.
  • Site Management: Assist with site budgets, contracts, and payment administration, as well as track subject recruitment and site monitoring visits. Help with communication to sites regarding protocol deviations and other relevant updates.
  • Study Start-up: Support Clinical Trial Managers and Project Managers in developing project plans, documents for site feasibility, selection, and activation.
  • Site Activation: Coordinate with the project team to retrieve and review regulatory documents required for trial initiation.
  • Document Management: Assist the project team in managing essential study documents, including review, filing, and archiving. Ensure proper maintenance of the Trial Master File.
  • Supplies Management: Help coordinate logistics, including printing study tools, securing study supplies, and managing their distribution and tracking at study sites.
  • Study Management: Assist in creating and maintaining project trackers and systems (CTMS, study portal), and distribute routine correspondence to the project team, sponsor, sites, and stakeholders.
  • Vendor Management: Help with vendor identification, qualification, selection, and ongoing management during the trial, including vendor payment administration.
  • Compliance: Adhere to international GCP guidelines, regulations, and SOPs for clinical studies. Assist the team in resolving audit findings and ensure audit readiness.
  • Client & Investigator Meetings: Participate in client presentations and investigator meetings as needed.
  • Timely Project Support: Assist the study team in meeting timelines and report any out-of-scope issues to management.
  • Additional Duties: Assist with other assigned tasks to support the project team.

Your Profile:

  • Associate’s or Bachelor’s degree in biomedical sciences or a related field, or equivalent experience.
  • Fluent in English (oral and written) and applicable local business language.
  • Prior clinical research experience is required. Experience as a study coordinator or regulatory coordinator is preferred.
  • Basic knowledge of ICH GCP and applicable regulatory requirements is desired.
  • Proficiency in MS Office Suite (Word, PowerPoint, Excel).
  • Strong organizational and communication skills.

If you meet the qualifications and are excited to be part of an energetic, creative, and collaborative team, we encourage you to apply directly on our website at biorasi.com or email us at careers@biorasi.com.

Benefits:

At Biorasi, we are committed to the health and well-being of our employees and their families. Our benefits include:

  • Half-day Fridays
  • Paid time off and holidays
  • Country-specific benefits
  • Employee bonus programs
  • Career growth and development opportunities

Biorasi is an Equal Opportunity Employer. We embrace diversity and are committed to providing equal employment opportunities for all qualified applicants, regardless of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We also comply with all fair employment practices regarding citizenship and immigration status.