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    Clinical Research Associate (Rare Disease)

    Propharma
    0-3 years
    Not Disclosed
    Remote, USA
    10 Aug. 7, 2024
    Job Description
    Job Type: Full Time 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: Clinical Research Associate

    Company: ProPharma Group

    About ProPharma:

    For the past 20 years, ProPharma has been at the forefront of improving patient health and wellness by providing expert advice and services. As the world’s largest Research Consulting Organization (RCO), we empower biotech, medical device, and pharmaceutical organizations to advance scientific breakthroughs and introduce new therapies. Through our advise-build-operate model, we support clients across the entire product lifecycle with deep expertise in regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology. Our customizable consulting solutions are designed to de-risk and accelerate high-profile drug and device programs.

    Job Summary:

    The Clinical Research Associate (CRA) will be responsible for overseeing clinical monitoring for assigned protocols and investigational sites. This role ensures that studies are conducted and documented in accordance with study protocols, standard operating procedures (SOPs), Good Clinical Practices (GCP), and other applicable regulatory requirements.

    Essential Functions:

    • Monitoring: Conduct all types of monitoring visits (site initiation, interim, and close-out) both in-person and remotely. Ensure monitoring report writing and completion adhere to SOPs and local regulatory requirements.
    • Documentation: Support the development of study-specific documentation, including monitoring trackers, guidelines, and site tools. Manage and train site personnel on protocol requirements, source documentation, and case report completion.
    • Data Management: Review and ensure accuracy and integrity of source documents and case report forms. Identify and resolve data issues.
    • Investigational Supplies: Manage, prepare, and track investigational supplies. Document dispensing, inventory, and reconciliation of supplies.
    • Site Management: Monitor site activities, including enrollment, protocol deviations, serious adverse events, and other trial-related activities to ensure compliance with the protocol and regulatory requirements.
    • Regulatory Oversight: Review and oversee regulatory documentation accuracy. Address regulatory concerns and maintain timely communication with sites, investigators, and cross-functional teams.
    • Collaboration: Participate in meetings and calls with internal project teams, sponsors, and external partners to support the execution of clinical trials.

    Necessary Skills and Abilities:

    • Experience: Prior experience in rare diseases and/or CNS therapeutic indications is preferred.
    • Communication: Excellent verbal, written, and interpersonal skills.
    • Technical Skills: Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint) and experience with Electronic Data Capture (EDC), CTMS, IVRS, and eTMF.
    • Regulatory Knowledge: Understanding of applicable regulations, ICH Guidelines, and GCPs governing clinical trials.
    • Organizational Skills: Ability to prioritize tasks, plan proactively, and work independently with minimal supervision. Strong organizational skills and attention to detail are essential.
    • Problem-Solving: Ability to offer solutions to obstacles and train as necessary to meet project goals.

    Educational Requirements:

    • Degree: Bachelor's degree or an equivalent combination of education and experience.

    Experience Requirements:

    • Experience: 0-3 years of experience as a Clinical Research Associate.

    Diversity and Inclusion:

    ProPharma celebrates diversity and is committed to creating an inclusive workplace where every individual can be their authentic self. We encourage employees to unleash their innovative, collaborative, and entrepreneurial spirits. As an Equal Opportunity Employer, we provide a safe space where all employees are empowered to succeed.

    Application Instructions:

    ProPharma Group does not accept unsolicited resumes from recruiters or third parties. Please refrain from calling or emailing regarding this posting.

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