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    Clinical Research Coordinator

    Katalyst Healthcares & Life Sciences
    2+ years
    Not Disclosed
    Rockville
    10 Nov. 11, 2024
    Job Description
    Job Type: Full Time 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

    Job Title: Immuno-Oncology Clinical Project Coordinator

    Location: Remote
    Employment Type: Contract

    Company Overview:

    Katalyst Healthcares & Life Sciences is hiring entry-level and experienced candidates for several contract research positions in clinical trials for drugs, biologics, and medical devices. We partner with university hospitals, pharmaceutical companies, and recruiting firms to bring innovative therapies to market.

    Position Overview:

    We are seeking a Clinical Project Coordinator to support the Immuno-Oncology (IO) Global Medicines group. The IO Clinical Project Coordinator will work with a cross-functional team to develop, maintain, and manage a web portal and database for the Toxicity Management Guidelines (TMGs) used across the IO Program. This role involves collaborating with various stakeholders, including project teams, physicians, IT teams, vendors, and external investigational sites globally.

    Key Responsibilities:

    • Website & Database Management: Collaborate with IT to develop and maintain a web portal and associated applications for IO project teams and external investigators.
    • Database Maintenance: Ensure proper management of investigator sites, including access control based on IRB and regulatory approval dates.
    • Communication & Collaboration: Develop and execute a communication plan to ensure the smooth exchange of information across internal and external stakeholders, including IT, Site Management & Monitoring (SM&M), and external vendors.
    • Process Improvement: Conduct gap analyses, propose, and implement process improvements for the management of TMGs and related processes.
    • Stakeholder Liaison: Work closely with the IO Lead Safety Physician and other stakeholders to ensure alignment and effective communication across global teams.

    Qualifications & Skills:

    • Education: Undergraduate degree (preferably in Life Sciences or a related field).
    • Experience:
      • General knowledge of the drug development process.
      • Experience in database management and process maintenance in a complex, multi-disciplinary environment.
      • Experience working in global, multi-cultural teams.
      • Proven ability to adapt quickly, learn rapidly, and transition between roles.
      • Experience with Clinical Trial Management Systems (CTMS), such as IMPACT.
      • Ability to develop, maintain, and improve processes for cross-functional teams.

    Additional Information:

    All personal information will be kept confidential in accordance with EEO guidelines.

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