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Cra/ Senior Clinical Research Associate

2-3 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 Summary

Biorasi, a dynamic and innovative global clinical research organization, is seeking experienced Clinical Research Associates (CRAs) to join our growing team. If you're passionate about clinical research and eager to contribute to driving new therapies to patients, Biorasi offers you the opportunity to be part of a fast-paced, evolving environment.

We value collaboration, innovation, and work-life balance. With Biorasi, you’ll become part of a company committed to delivering high-quality clinical trials and therapies globally.

Your Role

As a Clinical Research Associate, you will be responsible for managing and supporting clinical trial activities, ensuring compliance with protocols and regulations, and maintaining the quality and integrity of study sites. Key responsibilities include:

  • Site Visits:

    • Plan, schedule, and conduct Site Selection, Site Initiation, Interim Monitoring, and Site Close-out Visits.
    • Write reports and follow-up letters for each type of site visit.
  • Study Progress and Tracking:

    • Monitor the progress of assigned studies, including tracking regulatory/IRB submissions, recruitment, CRF completion, data queries, and resolutions.
    • Provide regular project updates to the project management team.
    • Ensure the delivery of investigational products, laboratory supplies, and study materials to clinical sites.
  • Study Site Management:

    • Perform investigational product inventory and ensure the return or destruction of unused products.
    • Assist in preparing for and attending Investigator Meetings.
    • Ensure compliance with study protocols, ICH GCP guidelines, and escalate any protocol deviations or safety issues to the project management team.
    • Collect and file essential study documents in the eTMF.
  • Training and Compliance:

    • Administer protocol and related training to site staff, ensuring adherence to study requirements.
    • Ensure the quality and integrity of site practices and compliance with applicable regulations.
    • Participate in quality assurance activities and assist with the resolution of audit findings.
  • Collaboration and Leadership:

    • Lead and participate in regular team meetings and teleconferences.
    • Provide mentorship and training to associates and junior staff on job performance and professional growth.
  • Other Duties:

    • Assist the Clinical Trial Manager with overseeing site performance, resource allocation, and review of site visit reports.
    • Provide feedback on site performance during project team meetings and assist in compiling feedback for study performance analysis.

Your Profile

  • Education: Bachelor’s Degree in biomedical sciences or a related scientific discipline.
  • Experience:
    • Minimum 2-3 years of monitoring experience in clinical trials, with a combination of clinical research coordination or other relevant clinical research experience.
    • Solid understanding of medical terminology, clinical monitoring processes, and clinical trial operations.
    • Knowledge of ICH GCP guidelines and applicable regulatory requirements.
  • Skills:
    • Strong communication, leadership, planning, and project management skills.
    • Proficiency with MS Office suite (Word, PowerPoint, Excel).
    • Ability to work effectively in interactive situations with peers, sites, and clients.

Compensation and Benefits

Biorasi offers a comprehensive benefits package, including:

  • Work-Life Balance: Half-day Fridays and generous paid time off (vacation, holidays, and sick days).
  • Health Benefits: Medical, dental, vision, life insurance, short-term and long-term disability.
  • Financial Benefits: Company matching 401(k), employee bonus programs, and career growth opportunities.
  • Career Development: Training, development, and support for professional growth.

Why Biorasi?

Biorasi is committed to innovation, collaboration, and maintaining a work-life balance. We foster a positive, diverse, and inclusive environment where your skills will help shape the future of clinical trials. We are proud to be an equal opportunity employer, offering career opportunities to all qualified applicants.

How to Apply

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at Biorasi Careers or email your resume to careers@biorasi.com.

Equal Opportunity Employer

Biorasi is committed to creating a diverse 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. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.