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    Senior Clinical Research Associate (Phase I)

    Premier Executive Transportation Inc
    5-7 years
    Not Disclosed
    Remote
    10 Aug. 20, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

    Position Overview:

    Senior Clinical Research Associate (Phase I, Central Region)
    Location: Central Region, United States

    At Premier Research, we're dedicated to turning groundbreaking ideas into real medical innovations. As a Senior Clinical Research Associate (Sr. CRA) on our Functional Services team, you'll play a crucial role in transforming biotech, medtech, and specialty pharma concepts into life-saving medicines, devices, and diagnostics. Our work profoundly impacts lives, and we value our team as the cornerstone of our success.

    Why Join Us:

    • Built for You: We support your growth with the skills and opportunities you need to excel professionally while maintaining a healthy work-life balance.
    • Built by You: Your ideas shape our work processes, and your voice is integral to our operations.
    • Built with You: As a vital team member, you contribute to delivering essential medical innovations.
    • Built for Biotech™: Be part of a team that is dedicated to building a future in biotech.

    What You’ll Be Doing:

    • Investigate and resolve data discrepancies identified during source verification.
    • Communicate effectively with clinical sites and project teams through monitoring reports, follow-up letters, study memos, and other correspondence.
    • Conduct on-site qualification, study initiation, interim monitoring, and close-out visits in accordance with the clinical monitoring plan.
    • Maintain thorough documentation and ensure proper escalation of issues.
    • Ensure site personnel are trained and prepared to conduct clinical studies according to the protocol and applicable regulations.
    • Address and document non-compliance issues, communicate them clearly, and escalate as needed.
    • Support regulatory inspection activities as required.

    What We Are Searching For:

    • Education: Bachelor’s degree or equivalent in a clinical, biological, scientific, or health-related field, or a combination of education, training, and experience.
    • Experience: 5 to 7 years of independent onsite monitoring and site management. Experience in a sponsor-embedded Functional Service Provider (FSP) model is highly preferred. Phase I and cardiology experience is also preferred.
    • Skills:
      • Excellent verbal and written communication skills in English.
      • Proven ability to deliver high-quality, timely results and maintain positive customer interactions.
      • Strong analytical and organizational skills, with the ability to manage multiple projects in a dynamic environment.
    • Location: Must be based in the Central Region of the United States (AR, CO, IL, IN, IA, KS, KY, LA, MI, MN, MO, MT, NE, NM, ND, OK, SD, TN, TX, WI, WY).

    Why Choose Premier Research:

    Premier Research is more than just a company; it's a community where people truly care about each other, our clients, and our mission to improve patients' lives. Our values—We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care—reflect our team's determination and flexibility.

    We provide innovative technologies and continuous learning opportunities to help our staff succeed. We believe that diverse perspectives fuel innovation and better connect us with the patients, physicians, and customers we serve.

    If you're excited about this role but your experience doesn’t perfectly align with the job description, we encourage you to apply. You might be the right candidate for this role or other opportunities.

    Equal Opportunity Employer:
    Premier Research is an equal opportunity employer. We comply with federal guidelines and provide equitable consideration to all qualified applicants without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.

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