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    Contract Senior Clinical Research Associate

    Caidya
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 4, 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 Description: Freelance Senior Clinical Research Associate

    Job Location: UK (Home-based)

    Job Overview:
    The Contract Sr. Clinical Research Associate monitors investigational sites to ensure subject safety and deliver high-quality data review and reporting. This role complies with Caidya and/or client Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, ISO14155, and applicable local regulations. The Associate builds and supports strong site relationships while acting as a liaison between the Sponsor and assigned sites.

    Job Duties and Responsibilities:

    • Support the Project Team and Clinical Operations Team.
    • Maintain a strong working knowledge of protocols and Monitoring Plans for assigned projects.
    • Serve as the primary contact for assigned research sites.
    • Schedule and conduct pre-study visits, initiation visits, interim monitoring visits, and close-out visits according to the Monitoring Plan.
    • Ensure research sites adhere to protocol requirements and applicable regulations.
    • Protect the rights and well-being of trial subjects.
    • Reconcile site regulatory binders, ensuring the collection and completeness of regulatory documents.
    • Collect essential regulatory documentation from sites from study start-up through close-out.
    • Verify that written informed consent is obtained before each subject's participation.
    • Conduct source data verification against Case Report Form/Electronic Data Capture entries per the Monitoring Plan.
    • Ensure the quality of all recorded data and resolve data queries promptly.
    • Manage Investigational Product accountability, including storage, inventory, and records.
    • Support the recording and reporting of adverse events, ensuring compliance with regulatory requirements.
    • Ensure sites have sufficient project-specific supplies.
    • Communicate deviations from protocols, SOPs, and GCP to investigators and project management, taking appropriate action to prevent recurrence.
    • Deliver high-quality written trip reports and follow-up letters within SOP timelines.
    • Participate in site audits as requested.
    • Uphold confidentiality agreements with all clients and colleagues.
    • Proactively identify, manage, escalate, and resolve site issues effectively.
    • Attend and participate in team meetings and investigator meetings.
    • Demonstrate flexibility and adaptability in the role.

    Supervisory Responsibilities:
    None

    Job Requirements:

    Education:

    • 4-year college graduate, preferably in healthcare or life sciences.
    • In lieu of a degree, candidates with 3+ years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.

    Experience:

    • Minimum of 3 years of experience in on-site monitoring of clinical studies.

    Skills/Competencies:

    • Strong written and verbal communication skills.
    • Strong interpersonal skills and the ability to conduct all types of site monitoring visits independently.
    • Good documentation skills and a strong command of English and the local language.
    • Proficient in Microsoft Office and knowledgeable in GCP/ICH guidelines.
    • Proficiency in medical terminology and ability to exercise judgment within defined procedures.
    • Exceptional attention to detail and superior problem-solving skills.
    • Strong time management and organizational skills.

    Capabilities:

    • Valid driver's license and the ability to drive, if applicable.
    • Valid passport required for international business travel.
    • Ability to travel as needed.

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