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    Medical Monitor (Argentina)

    Innovaderm Research
    3+ years
    Not Disclosed
    Argentina
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Education: Dermatologist/ MD 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: Medical Monitor
    Company: Innovaderm
    Location: Home-based position (Flexible work schedule)

    Overview

    Innovaderm is seeking a skilled Medical Monitor to provide medical and scientific support to clinical research programs. This role involves ensuring data integrity, subject safety oversight, and effective communication with clinical sites, investigators, and internal project teams.

    Responsibilities

    Protocols and Projects

    • Stay updated on study protocols, amendments, Investigator’s Brochure (IB), and relevant clinical research guidelines.
    • Develop or review the Medical Monitoring plan.
    • Provide training on study protocols and therapeutic areas to the project team.
    • Attend and present at Investigator’s Meetings.
    • Attend and participate in Safety Review Meetings as needed.
    • Provide 24/7 on-call service for urgent safety-related issues.
    • Offer ongoing medical support to investigators, site personnel, and monitors during the study.
    • Advise sites on protocol-related issues including inclusion/exclusion criteria, medications, and follow-up visits.
    • Review lab critical values and alerts and assess the impact of prohibited medications.
    • Evaluate subject drop-out and replacement appropriateness.
    • Provide emergency un-blinding code-break of randomized treatment assignments.

    Medical Dermatology Advisory Role

    • Provide project-related medical consultation to Innovaderm project team members.
    • Escalate significant safety or data integrity concerns to the Project Manager or Sponsor.
    • Attend meetings with Innovaderm team members and/or the Sponsor.
    • Verify the accuracy of subject safety data and assess the study's safety profile.
    • Review safety-related data listings to identify trends, protocol deviations, AEs, and SAEs.
    • Review clinical study reports and assess stopping rules.

    Data Activities

    • Participate in Central Monitoring for safety signal detection and risk management.
    • Review SAE forms and causality assigned by the Investigator.
    • Write and/or review SAE narratives.
    • Collaborate with Pharmacovigilance Services to review SAEs and follow up on safety queries.

    Safety Medical Monitoring and SAE Reporting

    • Assist with pharmacovigilance activities and serve as a non-voting member in committee meetings.
    • Support business development with proposal development and sales presentations.
    • Participate in feasibility discussions and draft SOPs for Medical Monitoring activities.

    Additional Duties

    • Perform other duties as assigned by the Director, Scientific and Regulatory Affairs or the Chief Medical Officer.

    Requirements

    Education

    • Medical degree (MD).

    Experience

    • Dermatologist with 3 years of Medical Monitoring experience or an MD with 3 years of Medical Monitoring experience in dermatology.

    Knowledge and Skills

    • Strong understanding of the drug development process.
    • Ability to work collaboratively in a multidisciplinary team and promote consensus.
    • Ability to manage multiple projects efficiently with shifting priorities.
    • Excellent verbal, written, and interpersonal communication skills.
    • Client-focused approach.
    • Knowledge of Good Clinical Practices and relevant regulations (Health Canada, FDA).

    About Innovaderm

    Innovaderm is a Contract Research Organization (CRO) specializing in dermatology, with a solid reputation for quality research and services. Founded in 2000, Innovaderm continues to grow across North America and Europe.

    Perks

    • Flexible work schedule and home-based position.
    • Ongoing learning and development opportunities.

    Equal Opportunity

    Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals, offering accommodations during the recruitment process for applicants with disabilities.

    Legal Eligibility

    Only applicants who can legally work in Argentina will be considered.

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