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    Sr Clinical Research Associate

    Medasource
    5+ years
    Preffered by Company
    Remote
    10 Sept. 3, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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 Title: Senior Clinical Research Associate

    Location: Remote with 50-70% Travel Required (Must be located in the Chicago area)

    Client: Large Life Sciences Company

    Start Date: ASAP (flexible)

    Duration: 12-month contract with potential for extension

    Hours: 20-30 hours per week initially, increasing to up to 35 hours per week

    Job Duties:

    • Monitor clinical studies at assigned sites and others as needed, ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), and accuracy standards during site initiation, periodic visits, and close-out visits.
    • Maintain regulatory and clinical protocol compliance for all assigned projects, including:
      • Reviewing data and source documentation for accuracy and completeness
      • Ensuring timely reporting of adverse events and protocol deviations
      • Reporting device complaints and malfunctions according to company policies and procedures
      • Resolving issues and facilitating the resolution of problems, including identifying causes and implementing actions to prevent recurrence
    • Coordinate with study teams, field clinical engineers, and specialists to:
      • Enroll sites in new and ongoing clinical studies
      • Facilitate subject enrollment via site coordinators
      • Address and resolve data queries and action items at clinical sites
      • Report monitoring visit findings according to company processes
    • Collaborate with in-house teams to ensure the complete submission of study documents
    • Participate in conference calls and training sessions
    • Train site personnel to ensure compliance with study protocols and local regulations
    • Mentor less experienced clinical team members as requested
    • Demonstrate strong written and verbal communication skills with internal and external stakeholders

    Minimum Qualifications:

    • Bachelor’s degree in a relevant field (e.g., natural science, pre-medicine, nursing, bioengineering)
    • At least five years of clinical research experience
    • Excellent written and verbal communication, interpersonal, presentation, analytical, and organizational skills
    • Ability to interpret basic clinical data and meet deadlines
    • Proficiency with word processing software and relevant clinical applications
    • Ability to work independently and as part of a dynamic, global team
    • Capable of exchanging straightforward information, asking questions, and ensuring understanding

    Preferred Qualifications:

    • Prior clinical monitoring experience
    • Familiarity with cardiac, vascular, and/or neuromodulation technologies
    • Experience in a medical device/pharmaceutical company or clinical/hospital environment
    • Certification by an industry-recognized professional society (e.g., Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP))

    If you meet the qualifications and are excited about the opportunity, please apply ASAP!

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