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    Sr. Clinical Trial Specialist Iii (Remote)

    Tandym Group
    2-8 years
    $46/hr - $56/hr
    Remote, USA
    10 Aug. 2, 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, 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 Title: Senior Clinical Trial Specialist (Remote)

    About the Job:

    Our client, a leading pharmaceutical company, is seeking a Senior Clinical Trial Specialist (CTS) to provide comprehensive logistical support for clinical trial programs. This role involves collaborating with cross-functional teams to ensure that site start-up through close-out activities adhere to Standard Operating Procedures (SOPs) and relevant regulations.

    Job Type: Remote
    Employment Type: W2 Only

    Responsibilities:

    • Study Feasibility: Actively participate in feasibility assessments for studies.
    • Document Management: Develop and review study documents (e.g., site instructions, lab manuals, Pharmacy Binder, Study Management Plan) and clinical site documents (e.g., site-specific informed consent forms).
    • Regulatory Compliance: Manage the collection, review, and approval of regulatory documents from clinical sites.
    • Investigational Product: Coordinate investigational product release activities across clinical sites.
    • Trial Master File: Initiate, maintain, and reconcile the Trial Master File.
    • Meeting Preparation: Assist in preparing for Investigator and Study Coordinator Meetings.
    • Tracking Systems: Set up and maintain tracking systems (e.g., CTMS), tools, and report study metrics.
    • Payments Management: Manage and track study-specific payments.
    • Communication: Coordinate and communicate tracking information within the study team and to clinical sites.
    • SOP Development: Develop and review Standard Operating Procedures.
    • Subject Matter Expert: Serve as an expert on CTS initiatives and working groups.
    • Mentorship: Mentor Clinical Trial Associates and peer CTSs, including onboarding new hires.
    • Vendor Management: Manage ancillary vendors, such as specialty or central labs.
    • Training Assistance: Assist in training Clinical Research Associates.
    • Site Visits: Perform site initiation, routine monitoring, and close-out visits at select clinical sites, including co-monitoring with Clinical Research Associates.
    • Report Review: Review site visit reports under the direction of the Associate Director or designee.
    • Additional Duties: Other responsibilities as assigned.

    Qualifications:

    • Education: Bachelor’s degree or equivalent (scientific or healthcare discipline preferred).
    • Experience: Fully proficient in clinical trial coordination with a thorough understanding of study phases and their application to clinical development.
    • Regulatory Knowledge: Working knowledge of ICH Good Clinical Practice guidelines.
    • Skills: Ability to handle multiple tasks and deadlines; self-motivated with strong problem-solving skills; effective verbal and written communication.
    • Relationships: Capability to build and maintain positive relationships with management and peers.
    • Technical Skills: Proficient in using computer applications, including spreadsheets, email, word-processing software, and web-based systems.
    • Travel: 10-30% travel may be required.

    To apply, please submit your resume and cover letter outlining your qualifications and experience.

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