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Senior Clinical Research Associate Contractor

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

Job Opportunity: Clinical Research Associate (CRA) at Biorasi

Biorasi, a fast-growing global clinical research organization (CRO), is looking for talented and passionate Clinical Research Associates (CRAs) to join our dynamic team. Whether you're an experienced clinical trial veteran or an industry newcomer, this is your chance to contribute to the development of innovative therapies and become part of a customer-focused, evolving organization.

Why Biorasi?

We are Innovative, Collaborative, Dynamic, and Evolving. Biorasi supports your career journey by capitalizing on your strengths while encouraging work-life balance. Join a global company that’s shaping the future of clinical research.

Your Role

As a Clinical Research Associate, you will be responsible for overseeing and supporting clinical trial activities, ensuring compliance with study protocols and regulatory requirements. Key responsibilities include:

  • Site Visits & Management:

    • Schedule, plan, and conduct Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits, and Site Close-out Visits.
    • Write Reports and Investigator Follow-up Letters for each type of site visit.
    • Track study progress, including regulatory/IRB submissions, recruitment, CRF completion, data queries, and resolution.
    • Manage the delivery of investigational products, laboratory supplies, CRFs, and other study materials to clinical sites.
    • Perform investigational product inventory and ensure the return or destruction of unused products.
  • Study & Site Compliance:

    • Review study documents for compliance with protocols, ICH GCP guidelines, and regulatory requirements.
    • Identify Protocol Deviations, Violations, or Waivers and escalate any safety events to the project management team.
    • Administer protocol and study training to site staff and establish strong communication lines to manage ongoing expectations.
    • Evaluate site practices to ensure adherence to applicable regulations and maintain high-quality study standards.
  • Collaboration & Mentorship:

    • Assist the Clinical Trial Manager in clinical operations, resource allocation, site performance review, and issue resolution.
    • Lead and participate in regular team meetings and teleconferences.
    • Mentor junior team members, providing guidance on job performance and professional growth.
  • Travel Requirement:

    • Ability to travel up to 70% depending on project needs.

Your Profile

To succeed in this role, you should meet the following qualifications:

  • Education: Bachelor’s Degree in Biomedical Sciences or a related scientific discipline.
  • Experience: Minimum 3 years of clinical monitoring experience, with a combination of clinical research coordinator or other relevant clinical research roles. More experience is preferred.
  • Knowledge:
    • Advanced proficiency in the clinical monitoring process and medical terminology.
    • Solid understanding of ICH GCP and worldwide applicable regulatory requirements.
    • Familiarity with MS Office Suite (Word, PowerPoint, Excel).
  • Skills: Strong leadership, planning, project management, and communication skills (both verbal and written).

Compensation & Benefits

Biorasi offers a competitive benefits package, designed to enhance your health and well-being, including:

  • Work-Life Balance: Half-day Fridays, paid time off, and paid holidays.
  • Health Benefits: Medical, dental, vision, life insurance, short-term and long-term disability.
  • Financial Benefits: Company-matched 401(k), employee bonus programs.
  • Career Development: Opportunities for training, growth, and career advancement.

How to Apply

If you have the experience required and are eager to join a dynamic, creative, and collaborative team, please apply directly at Biorasi Careers or email your resume to careers@biorasi.com.

Equal Opportunity Employer

Biorasi is proud to be an equal opportunity employer. We are committed to a diverse and inclusive work environment, ensuring that all qualified applicants 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 adhere to fair employment practices regarding citizenship and immigration status.

Join us at Biorasi and make an impact on the future of clinical research!