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    Cra/ Senior Clinical Research Associate

    Biorasi
    2-3 years
    Not Disclosed
    Remote
    10 Oct. 8, 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

    CRA/Senior Clinical Research Associate
    Remote - India

    Join us at Biorasi, where your career journey is supported in an innovative, collaborative, and dynamic environment. As an award-winning, customer-focused full-service clinical research organization, we value your strengths while promoting a healthy work-life balance.

    We are seeking passionate clinical research professionals—both seasoned veterans and newcomers—to thrive in our fast-paced setting and contribute to advancing new therapies for patients. Here’s your opportunity to become an integral part of our growing global team in the expanding clinical research industry.

    Your Role:

    • Site Visits: Schedule, plan, and conduct site selection, initiation, interim monitoring, and close-out visits.
    • Documentation: Write reports and investigator follow-up letters for all site visits.
    • Study Management: Track the progress of assigned studies, including regulatory/IRB submissions, recruitment and enrollment, CRF completion, and data query resolution.
    • Project Updates: Provide regular updates to the project management team.
    • Logistics: Organize the delivery of investigational products, laboratory supplies, CRFs, and other study-specific materials to and from clinical sites.
    • Inventory Management: Perform inventory checks of investigational products and ensure the proper return or destruction of unused items.
    • Investigator Meetings: Assist in preparing for and attending investigator meetings for assigned studies.
    • Compliance Review: Review study documents for compliance with protocols and ICH GCP guidelines, and escalate any issues as necessary.
    • Documentation Collection: Gather and review essential study documents for filing in the eTMF.
    • Training Administration: Administer protocol and study training to assigned sites, maintaining communication to manage 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 with clinical operations activities, resource allocation, and site performance reviews.
    • Mentorship: May mentor associates regarding job performance and professional growth.
    • Team Meetings: Lead and participate in regular team meetings and teleconferences.
    • Other Duties: Perform additional tasks as assigned.

    Your Profile:

    • Education: Bachelor’s degree in biomedical sciences or a related scientific discipline.
    • Language Skills: Fluent in English (oral and written) and applicable local business language.
    • Experience: Minimum of 2-3 years of monitoring experience preferred, along with relevant clinical research coordinator experience.
    • Knowledge Base: Strong understanding of medical terminology, clinical monitoring processes, ICH GCP, and applicable regulatory requirements.
    • Communication Skills: Excellent verbal and written communication skills, with the ability to present effectively.
    • Leadership Skills: Strong planning, project management, and interpersonal skills.
    • Technical Skills: Proficient in MS Office suite (Word, PowerPoint, Excel).
    • Business Acumen: Effective in interactive situations with peers, sites, and clients.

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

    Benefits:

    Biorasi offers thoughtfully designed benefits to enhance your health and well-being, including half-day Fridays, paid time off, holidays, extensive country-specific benefits, employee bonus programs, and opportunities for career growth and development.

    Biorasi is committed to fostering 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. We are also committed to fair employment practices regarding citizenship and immigration status.

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