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    Sr Cra I

    Syneos Health
    2+ years
    Not Disclosed
    Lakeway Remote Korea
    10 Nov. 29, 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

    Senior Clinical Research Associate I (CRA I)

    Company: Syneos Health
    Location: [Location not specified]

    About Syneos Health

    Syneos Health is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With 29,000 employees across 110 countries, Syneos Health brings unique clinical, medical affairs, and commercial insights to address market realities and deliver therapies faster.

    "Work Here Matters Everywhere"

    Why Syneos Health?

    Syneos Health offers career development, progression, and opportunities for learning and growth. We value authenticity, foster a culture of inclusivity, and support diverse perspectives to create a workplace where everyone feels they belong.

    Role Overview

    As a Senior Clinical Research Associate I (CRA I), you will be responsible for site qualification, initiation, monitoring, management, and close-out visits, ensuring compliance with regulatory standards and protocol requirements. This role involves working independently to oversee site performance, monitor safety and data integrity, and mentor junior CRAs. You will also play a key role in the planning and execution of clinical trials, contributing to site recruitment, retention, and audit readiness.

    Key Responsibilities

    • Site Management & Monitoring:

      • Conduct site qualification, initiation, interim monitoring, and close-out visits (either on-site or remotely), ensuring compliance with regulatory guidelines (ICH-GCP, GPP, protocol).
      • Perform source document reviews to verify clinical data entered into case report forms (CRFs) and resolve any queries.
      • Ensure the informed consent process is conducted appropriately and that subject confidentiality is maintained.
      • Assess factors affecting subject safety and data integrity, and escalate any serious issues to the project team.
      • Manage investigational product (IP) inventory, reconciliation, storage, and security, ensuring adherence to protocol guidelines.

    • Project Support & Communication:

      • Ensure sites are compliant with electronic data capture (EDC) requirements.
      • Regularly update the Investigator Site File (ISF) for accuracy and ensure it aligns with the Trial Master File (TMF).
      • Document all site activities and interactions in accordance with SOPs, including confirmation letters, trip reports, and communication logs.
      • Provide guidance and mentorship to junior CRAs and assist in training new staff.

    • Study Lifecycle & Audit Readiness:

      • Participate in investigator meetings and sponsor face-to-face meetings as required.
      • Provide guidance towards audit readiness and support audit preparations and follow-up actions.
      • Collaborate with other team members to identify site recruitment strategies, support patient retention, and ensure regulatory compliance throughout the study lifecycle.

    • Real World Late Phase Studies (RWLP):

      • For RWLP studies, you will assist in site support, chart abstraction, and collaborate with regulatory teams to ensure up-to-date regulatory information.
      • Provide input on site selection based on knowledge of local treatment patterns, patient advocacy, and healthcare provider associations.

    Qualifications

    Education & Experience:

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
    • Proficient in clinical monitoring, including site management, monitoring, and adherence to study protocols.
    • Experience with real-world late-phase studies (RWLP) is preferred.

    Skills & Competencies:

    • Strong computer skills and proficiency with new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Basic critical thinking abilities, with a focus on site-level problem-solving and decision-making.
    • Ability to manage travel requirements (up to 75%) and work in a dynamic environment.

    Why Work with Us?

    • Career Growth: Syneos Health offers extensive career development and skill-building opportunities.
    • Collaborative Environment: Work in an inclusive culture with a focus on diversity and personal growth.
    • Global Impact: Be part of a team that works with top global biopharmaceutical organizations and contributes to the development of life-saving therapies.

    Apply Now to join Syneos Health, where you’ll play a pivotal role in advancing clinical trials and improving the health outcomes of patients worldwide.

    Syneos Health is committed to building a diverse and inclusive workplace. We encourage individuals from all backgrounds to apply, and we value transferable skills. Join our Talent Network to stay connected to additional opportunities.

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