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    Sponsor Dedicated Sr Cra Ii - Oncology

    Syneos Health
    2-8 years
    Not Disclosed
    Remote, USA
    10 Aug. 13, 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

    Senior Clinical Research Associate II

    About Syneos Health: Syneos Health® is a leading biopharmaceutical solutions organization, dedicated to accelerating customer success. We integrate clinical, medical affairs, and commercial insights to address the complexities of today's market, putting the customer and patient at the center of everything we do. Our innovative approach is designed to streamline processes and create an environment that is both efficient and fulfilling to work in.

    Why Join Us? At Syneos Health, our people are our greatest asset. We are committed to fostering a culture that supports career development, progression, and personal well-being. Through engaged line management, comprehensive training, and peer recognition, we ensure that our employees have the tools they need to succeed.

    Our Total Self culture encourages everyone to bring their authentic selves to work. We believe that diversity of thought, background, and experience makes us stronger, and we're dedicated to creating a workplace where everyone feels they belong.

    Job Responsibilities:

    • Conduct site qualification, initiation, interim monitoring, management, and close-out visits, both on-site and remotely, ensuring compliance with regulatory, ICH-GCP, and protocol requirements.
    • Assess site processes, verify informed consent documentation, and ensure subject/patient confidentiality.
    • Review clinical data for accuracy and completeness, utilizing query resolution techniques and ensuring compliance with electronic data capture requirements.
    • Manage investigational product (IP) inventory, ensuring proper storage, labeling, and dispensing according to protocol and regulations.
    • Maintain the Investigator Site File (ISF) and ensure its alignment with the Trial Master File (TMF).
    • Document activities and communications according to SOPs and Clinical Monitoring Plan/Site Management Plan.
    • Support recruitment, retention, and subject/patient awareness strategies, and enter data into tracking systems.
    • Manage site-level activities to ensure project objectives, deliverables, and timelines are met.
    • Act as a primary liaison with study site personnel, ensuring compliance and training of site team members.
    • Prepare for and attend Investigator Meetings, sponsor meetings, and global clinical monitoring/project staff meetings.
    • Provide site and project-level guidance towards audit readiness and support audit preparation.
    • Mentor and supervise junior CRAs, providing training and oversight as needed.
    • Participate in business development proposals and defense meetings under the supervision of an experienced Clinical Operations Lead (COL) or operational line manager.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
    • Solid background as a CRA, with significant experience as a Senior CRA, particularly within the UK and in a Pharma or CRO environment.
    • Extensive knowledge of Good Clinical Practice (GCP) and ICH Guidelines, along with other applicable regulatory requirements.
    • Oncology experience is essential.
    • Strong communication, presentation, and interpersonal skills, with a moderate level of critical thinking.
    • Ability to manage travel requirements of up to 50% on a regular basis.

    About Syneos Health: In the last five years, we have supported 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 sites and 675,000+ trial patients. At Syneos Health, you’ll be part of a dynamic and innovative team, challenging the status quo and driving the future of clinical development.

    Additional Information: The tasks and responsibilities outlined in this job description are not exhaustive. Syneos Health may assign additional duties or modify job responsibilities at its discretion. Equivalent experience, skills, or education will be considered, and qualifications may differ from those listed. The company is committed to compliance with the Americans with Disabilities Act and providing reasonable accommodations when necessary.

    Apply Now: If you're passionate about making a difference and believe you have the skills to contribute to our team, we encourage you to apply—even if your experience doesn't align perfectly with the requirements. Join our Talent Network to stay connected to future opportunities at Syneos Health.

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