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    Senior Clinical Research Associate - Sponsor Dedicated - Ph I Oncology (Home-Based In Alberta)

    Syneos Health
    0-2 years
    Not Disclosed
    Remote, USA
    10 Dec. 23, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Here’s a rewritten version of the description with improved clarity and readability while maintaining professionalism:

    Job Title: Senior Clinical Research Associate I
    Organization: Syneos Health®

    About Syneos Health
    Syneos Health® is a fully integrated biopharmaceutical solutions company, focused on accelerating success for our customers. By combining clinical, medical affairs, and commercial insights, we deliver outcomes that address modern market challenges.

    Our Clinical Development model places the customer and patient at the center of everything we do. We strive to simplify processes, streamline work, and foster a collaborative environment to make Syneos Health not only an easier partner to work with but also an excellent place to work.

    Whether you join us as part of a Functional Service Provider (FSP) partnership or in a Full-Service environment, you’ll collaborate with passionate problem solvers dedicated to innovation and excellence. Together, we work to accelerate the delivery of therapies and improve lives.

    With a workforce of over 29,000 employees across 110 countries, we believe: Work Here Matters Everywhere.

    Why Syneos Health

    At Syneos Health, we are committed to:

    • Professional Growth: Offering career development opportunities, supportive line management, and specialized technical and therapeutic training.
    • Recognition and Rewards: Providing peer recognition and a comprehensive rewards program.
    • Inclusive Culture: Embracing diversity and fostering a culture where you can be your authentic self. Our global Total Self culture ensures every team member feels valued and supported.
    • Collaboration: Creating a space where diverse thoughts, backgrounds, and perspectives come together to build a sense of belonging.

    Key Responsibilities

    • Conduct site qualification, initiation, monitoring, and close-out visits (on-site or remote) in compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol standards.
    • Evaluate site and staff performance, ensuring adherence to regulatory and protocol requirements. Escalate issues as needed and develop action plans.
    • Verify informed consent processes, maintaining patient confidentiality and safety, while assessing protocol deviations and pharmacovigilance risks.
    • Perform activities per the Clinical Monitoring/Site Management Plan (CMP/SMP):
      • Assess site processes.
      • Conduct Source Document Review and verify clinical data accuracy.
      • Resolve queries and guide site staff to meet timelines.
      • Ensure compliance with electronic data capture (EDC) requirements.
    • Review and reconcile the Investigator Site File (ISF) and Trial Master File (TMF). Ensure proper archiving of essential documents per regulations.
    • Maintain thorough documentation of activities, including confirmation and follow-up letters, trip reports, and communication logs.
    • Support recruitment and retention strategies, and enter data into tracking systems to ensure observations and actions are resolved.
    • Manage site-level communication and activities to meet project deliverables and timelines. Adapt to changing priorities as needed.
    • Serve as a primary liaison with site personnel and ensure all assigned sites comply with project requirements.
    • Participate in investigator meetings, sponsor meetings, and global monitoring/project staff sessions.

    Additional Responsibilities for Real-World Late Phase (RWLP) Studies

    • Support sites throughout the study lifecycle, including chart abstraction and data collection.
    • Collaborate with sponsors, affiliates, and regulatory teams to ensure compliance with local requirements.
    • Identify operational efficiencies, process improvements, and potential sites based on local knowledge.
    • Develop country-specific informed consent forms.
    • Participate in bid defense meetings and provide support for regulatory updates.

    Qualifications

    • Bachelor’s degree or RN in a related field (or equivalent combination of education, training, and experience).
    • Proficiency in Good Clinical Practice (GCP)/ICH Guidelines and applicable regulatory requirements.
    • Strong computer skills and ability to adapt to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Willingness to travel up to 75% regularly.

    About Syneos Health

    Over the last five years, we have supported 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and conducted over 200 studies at 73,000 sites with 675,000+ trial patients.

    At Syneos Health, every role is an opportunity to challenge the status quo and drive innovation in a competitive and evolving environment. Learn more about our mission and culture.

    Additional Information

    The responsibilities outlined in this description are not exhaustive. The company may assign additional tasks or modify the role as necessary to meet organizational needs. We are dedicated to compliance with all relevant legislation, including providing reasonable accommodations under the Americans with Disabilities Act.

    This version refines the language and layout for readability, ensuring it communicates the role and organization effectively. Let me know if you’d like any further edits!

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