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    Clinical Research Associate

    Tigermed
    0-2 years
    Not Disclosed
    Remote, USA
    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: Senior Clinical Research Associate (CRA)

    Location: Home-based (Washington, Oregon, Colorado, Wyoming, Montana, Utah, Arizona, Idaho, Nevada, New Mexico)
    Employment Type: Permanent, Full-Time

    Company Overview:

    We are one of the fastest-growing Contract Research Organizations (CRO), offering a dynamic work environment and the opportunity to grow within an expanding organization. We are currently seeking a Senior Clinical Research Associate (CRA) to join our team. This is a permanent, home-based position, and the successful candidate can be located in several U.S. states, including Washington, Oregon, Colorado, Wyoming, Montana, Utah, Arizona, Idaho, Nevada, and New Mexico.

    Position Overview:

    As a Senior Clinical Research Associate (CRA), you will be responsible for monitoring clinical trials, ensuring that they are conducted in compliance with clinical protocols, and adhering to applicable federal regulations and FDA guidelines. You will play a critical role in safeguarding the rights and safety of human subjects involved in clinical studies while ensuring data quality and integrity.

    Key Responsibilities:

    • Site Monitoring: Conduct on-site monitoring visits, ensuring that clinical trials are conducted according to the study protocol, Good Clinical Practices (GCPs), and regulatory requirements.
    • Investigator Recruitment: Participate in the recruitment process by performing initial qualification visits of potential investigators, evaluating their capabilities to manage and conduct the clinical study.
    • Study Preparation: Coordinate with the Study Start-up Group and site staff to ensure the smooth initiation of studies, including obtaining regulatory approvals (IRB/EC) and completing required documentation.
    • Training & Support: Train site staff on the use of the EDC system, protocol requirements, and regulatory issues, ensuring smooth and compliant trial execution.
    • Data Review & Query Resolution: Review the quality and integrity of clinical data, perform source verification, and work with sites to resolve data queries. Ensure timely and accurate data transmission to the study database.
    • Documentation & Compliance: Conduct audits of site files to ensure adherence to GCPs, track investigational product inventory, and verify proper storage and handling of clinical trial materials.
    • Reporting & Communication: Prepare timely monitoring reports, document clinical findings, and serve as the primary point of contact between the company and study sites.
    • Study Close-Out: Perform study close-out visits, assist with final data review, and resolve any outstanding issues before database lock.
    • Mentorship: Mentor junior CRAs and provide guidance on monitoring activities and study procedures.
    • Travel: Travel domestically and internationally as needed (approximately 50-75% of the time).

    Qualifications & Skills:

    • Educational Background: BS/BA in life sciences or a related field.
    • Experience: Proven experience in monitoring and/or coordinating clinical trials. Experience in a clinical setting is a plus.
    • Knowledge of Clinical Research: Strong understanding of the clinical research process, medical terminology, and current GCP/ICH guidelines.
    • Technical Skills: Familiarity with electronic data capture (EDC) systems and basic data processing functions.
    • Communication Skills: Strong written and verbal communication skills with the ability to express complex ideas clearly to study personnel at research and clinical institutions.
    • Organizational Skills: Excellent organizational and interpersonal skills with the ability to prioritize tasks, manage timelines, and work independently.
    • Mentorship: Ability to mentor and support junior CRAs in field monitoring activities.
    • Travel & Logistics: Valid driver’s license, ability to rent an automobile, and willingness to travel both domestically and internationally (50-75% of the time).
    • Language: Proficiency in English (required).
    • Work Authorization: Must be authorized to work in the United States (required).

    Additional Requirements:

    • Ability to qualify for a major credit card for business travel.
    • Willingness to work in rotational shifts or as needed.
    • Prior experience in pharmaceutical or biotech-related clinical trials is highly preferred.

    Equal Opportunity Employer:

    We are an equal opportunity employer and value diversity in our workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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