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    Bilingual Clinical Research Associate Ii (Cra Ii)

    Innovaderm Research
    1-3 years
    Not Disclosed
    Montreal
    Not Disclosed Nov. 24, 2024
    Job Description
    Job Type: Full Time 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

    Bilingual Clinical Research Associate II (CRA II)

    Overview
    The CRA II plays a key role in ensuring clinical studies are conducted according to protocols, SOPs, ICH-GCP, and all applicable regulatory requirements. Working either remotely or on-site, the CRA II monitors study progress, ensures data accuracy, and builds productive relationships with investigators and site staff.

    This role is ideal for experienced CRAs seeking opportunities to specialize in dermatology within a mid-sized CRO where contributions are recognized and valued.

    Responsibilities

    • Conduct site qualification, initiation, monitoring, and close-out visits per study protocols, Innovaderm SOPs, and ICH-GCP guidelines.
    • Participate in investigators' meetings to align on study goals and expectations.
    • Prepare comprehensive site visit reports and follow-up letters to investigators.
    • Build strong relationships with investigators and site staff to facilitate study objectives, including patient recruitment.
    • Verify source data and ensure proper on-site drug storage, dispensing, accountability, and regulatory documentation.
    • Perform additional responsibilities as assigned, with appropriate training and qualifications.

    Requirements

    Education

    • Bachelor’s degree in a field relevant to clinical research or nursing, or equivalent experience.

    Experience

    • 1-3 years of on-site clinical monitoring experience in the biotechnology, pharmaceutical, or CRO industries.
    • Experience with phase 1 units or monitoring phase 1 studies (an asset).

    Knowledge and Skills

    • Strong understanding of ICH-GCP standards and applicable regulations.
    • Excellent verbal and written communication skills in English.
    • Proven ability to prioritize tasks, maintain attention to detail, and meet deadlines under pressure.
    • Strong problem-solving and decision-making skills.
    • Willingness to travel approximately 65% of the time.
    • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
    • Dermatology experience (an asset).

    Why Innovaderm?

    Perks and Benefits

    • Flexible work schedule.
    • Permanent full-time, remote position with regional travel.
    • Comprehensive benefits, including medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, and social activities.
    • Ongoing professional development opportunities.

    Work Environment

    • Home-based position with a dedicated office or workspace.
    • Proximity to a major travel hub in Canada required.

    About Innovaderm

    Founded in 2000 and headquartered in Montreal, Innovaderm is a Contract Research Organization (CRO) specializing in dermatology. With a reputation for exceeding client expectations, Innovaderm is growing across North America and Europe, offering an innovative and collaborative work environment.

    Commitment to Equity
    Innovaderm is dedicated to equitable treatment and providing equal opportunities to all. Accommodations are available throughout the recruitment process for applicants with disabilities upon request.

    Applicants must be legally authorized to work in Canada.

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