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    Clinical Research Associate

    Tigermed
    0-2 years
    Not Disclosed
    Remote, USA
    10 Nov. 6, 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: Senior Clinical Research Associate (SCRA) – Home-Based (Multiple Locations)

    Location: Washington, Oregon, Colorado, Wyoming, Montana, Utah, Arizona, Idaho, Nevada, New Mexico (Home-Based)

    About the Role:

    An exciting opportunity has arisen for a Senior Clinical Research Associate (SCRA) to join one of the fastest-growing CROs. This is a home-based position with flexibility to be based in Washington, Oregon, Colorado, Wyoming, Montana, Utah, Arizona, Idaho, Nevada, or New Mexico. As an SCRA, you will play a key role in the successful monitoring and oversight of clinical trials, ensuring compliance with regulatory requirements and safeguarding the rights and safety of trial participants.

    Responsibilities:

    • Monitor Clinical Trials: Ensure that clinical trials are conducted in accordance with federal regulations, FDA guidelines, and the study protocol.
    • Site Qualification & Recruitment: Participate in the investigator recruitment process, conduct initial qualification visits, and evaluate sites' ability to manage clinical studies.
    • Study Start-up: Collaborate with the Study Start-up Group to prepare sites for study initiation, including obtaining regulatory approvals and training site staff on study protocols and eCRF completion.
    • Site Training: Provide training to site staff on the EDC system and ensure proper setup of site computer systems.
    • On-Site Monitoring: Perform site visits to ensure compliance with GCPs and SOPs. Conduct source document verification and ensure data quality.
    • Investigational Product Management: Manage clinical trial materials, ensuring proper storage, accountability, and return or destruction of materials.
    • Data Review & Query Resolution: Review electronic CRFs and work with sites to resolve data queries.
    • Study Close-Out: Assist with study close-out activities and review final data before database lock.
    • Investigator Liaison: Serve as the primary point of contact between the company and study sites, facilitating communication and timely data transmission.
    • Mentorship: Provide guidance and mentorship to new clinical study monitors as needed.
    • Auditing: Request and perform site audits to validate study data as required.

    Qualifications & Skills:

    • Experience: Proven experience in monitoring and/or coordinating clinical trials. Clinical setting experience is a plus.
    • Education: BS/BA in life sciences or a related field.
    • Knowledge: Familiarity with the clinical research process, medical terminology, and GCP/ICH guidelines.
    • Skills: Strong organizational, communication, and interpersonal skills. Ability to think critically and recommend solutions in clinical settings.
    • Data Capture: Understanding of electronic data capture (EDC) systems and data processing functions.
    • Travel: Willingness to travel 50-75% domestically and internationally.
    • Licenses & Certifications: Valid driver’s license and eligibility for a major credit card.
    • Work Authorization: Must be authorized to work in the United States.

    Why Join Us?

    • Be part of one of the fastest-growing CROs in the industry.
    • Flexible home-based position with travel opportunities.
    • Work in a dynamic, collaborative environment where you can make a real impact on the success of clinical trials.
    • Competitive salary and benefits package.

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