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    Cra Ii/Sr Cra - Sponsor Dedicated - Respiratory (Home-Based, Pa/Va/Wv/Oh/In/Il))

    Syneos Health
    0-2 years
    $63,090 to $145,000
    Remote, USA
    10 Dec. 22, 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

    Job Title: Clinical Research Associate II
    Company: Syneos Health®

    About Syneos Health
    Syneos Health is a global, fully integrated biopharmaceutical solutions organization. We focus on accelerating the success of our clients by transforming clinical, medical affairs, and commercial insights into actionable outcomes. Our approach places the customer and patient at the center of everything we do, driving streamlined, impactful work to simplify processes and improve results.

    With 29,000 employees across 110 countries, we are passionate about delivering therapies that change lives.

    Why Syneos Health?

    • Career Development: We prioritize your professional growth with career progression opportunities, peer recognition, technical training, and a supportive work environment.
    • Inclusive Culture: Our Total Self culture promotes authenticity and inclusivity, ensuring every employee feels like they belong.
    • Global Impact: Join a global team that works with diverse perspectives to address modern healthcare challenges and deliver impactful therapies.

    Key Responsibilities:

    • Site Monitoring: Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely). Ensure compliance with regulatory standards, ICH-GCP, and the protocol.
    • Informed Consent & Confidentiality: Ensure informed consent is obtained and documented properly for each subject. Safeguard subject/patient confidentiality and assess factors impacting safety and data integrity.
    • Data Review & Query Resolution: Conduct source document review, verify accuracy of clinical data, and resolve queries both remotely and on-site. Ensure compliance with electronic data capture requirements.
    • Investigational Product (IP) Management: Oversee inventory, reconciliation, and storage of investigational products, ensuring proper dispensation and adherence to protocol.
    • Investigator Site File (ISF) Maintenance: Review ISF for accuracy and completeness, ensuring compliance with regulatory archiving guidelines.
    • Documentation & Reporting: Maintain accurate documentation, including trip reports, communication logs, and follow-up letters, and track action items to resolution.
    • Project Management: Manage site-level activities, communication, and budgets to ensure project objectives and timelines are met. Adapt to changing priorities and goals.
    • Audit Readiness & Compliance: Guide sites to meet audit readiness standards, assist with audits, and support necessary follow-up actions.
    • Training & Support: Provide training to site personnel on clinical study protocols and regulatory compliance. Collaborate with internal and external stakeholders to ensure project success.
    • Late Phase Real World Studies (RWE): For RWE, provide site support, perform chart abstraction and data collection, and collaborate with local teams, affiliates, and medical science liaisons.

    Qualifications:

    • Education: Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
    • Experience: Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements.
    • Skills:
      • Strong computer skills and willingness to learn new technologies.
      • Excellent communication, presentation, and interpersonal skills.
      • Ability to manage up to 75% travel on a regular basis.

    Additional Information:

    • Compensation and Benefits:
      • Base salary: $63,090 to $145,000, based on experience and qualifications.
      • Health benefits (Medical, Dental, Vision), company car or allowance, 401k match, employee stock purchase plan, and flexible paid time off (PTO) and sick leave.
    • COVID-19 Vaccination: Syneos Health strongly encourages employees to be vaccinated in compliance with company and local regulations.
    • Equal Opportunity: Syneos Health is committed to diversity, equity, and inclusion, and we support compliance with the Americans with Disabilities Act.

    Join Syneos Health to be part of a team that’s shaping the future of healthcare and delivering life-changing therapies to patients worldwide!

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