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    Cra Ii - Fsp - Anywhere In Turkey

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 8, 2024
    Job Description
    Job Type: Full Time Remote 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 II (CRA II) – Oncology Experience Preferred

    Location: Anywhere in Turkey
    Company: Syneos Health
    Travel: Up to 75% travel within Turkey

    About Syneos Health

    Syneos Health® is a fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We leverage unique clinical, medical, and commercial insights to address the dynamic realities of today’s market.

    Our Clinical Development model places both the customer and the patient at the core of everything we do. We are continuously working to streamline and simplify our processes to not only make Syneos Health easier to work with but to also ensure we are an outstanding company to work for.

    Whether you are working in a Functional Service Provider (FSP) partnership or within a Full-Service environment, you’ll collaborate with innovative problem solvers to achieve shared goals and deliver impactful therapies that change lives.

    Join Syneos Health, and discover what our 29,000 employees in 110 countries already know: WORK HERE MATTERS EVERYWHERE.

    Why Syneos Health?

    We are passionate about developing our people through career development, progressive opportunities, supportive line management, specialized training, peer recognition, and a total rewards program.

    At Syneos Health, we value our Total Self culture, where you can bring your authentic self to work. By embracing diversity in thoughts, backgrounds, and perspectives, we create an inclusive environment where everyone belongs.

    Job Responsibilities

    As a Clinical Research Associate II (CRA II), you will be responsible for site management and monitoring, ensuring regulatory and protocol compliance, and contributing to the successful execution of clinical studies.

    • Site Monitoring & Management:

      • Perform site qualification, initiation, interim monitoring, and close-out visits (on-site and remotely).
      • Ensure compliance with ICH-GCP, regulatory requirements, and study protocols.
      • Provide recommendations on site performance and escalate issues as needed.

    • Informed Consent & Patient Safety:

      • Verify that informed consent is properly documented and patient confidentiality is maintained.
      • Identify any risks to patient safety or data integrity, including protocol violations or pharmacovigilance concerns.

    • Source Document Review & Query Resolution:

      • Conduct thorough source document reviews and verify the accuracy and completeness of clinical data entered in the Case Report Form (CRF).
      • Resolve queries both remotely and on-site, ensuring timely closure in line with study timelines.

    • Investigational Product (IP) Management:

      • Perform investigational product inventory and ensure proper dispensing, administration, and security at the site in accordance with the protocol.
      • Ensure that IP labeling, storage, and return procedures meet GCP/local regulations.

    • Documentation & Compliance:

      • Regularly review Investigator Site Files (ISF) and reconcile them with the Trial Master File (TMF).
      • Ensure all essential documents are archived according to regulatory requirements.
      • Document site visits and activities, ensuring accurate records in compliance with SOPs and the Clinical Monitoring Plan (CMP).

    • Project Coordination & Communication:

      • Manage site-level activities, ensuring project timelines, objectives, and deliverables are met.
      • Communicate effectively with study site personnel, serving as the primary liaison.
      • Participate in global clinical monitoring meetings and ensure sites are trained and compliant with study requirements.

    • Audit Readiness & Compliance:

      • Support audit preparation and provide guidance to maintain audit readiness.
      • Adhere to and stay current with ICH-GCP, regulatory requirements, and company SOPs.

    • Training & Mentorship:

      • May provide training to junior CRAs and support the onboarding of new staff members.
      • Participate in Investigator Meetings and sponsor meetings as needed.

    Qualifications

    • Education:

      • Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.

    • Experience:

      • At least 2 years of experience as a Clinical Research Associate (CRA), with oncology experience preferred.
      • Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and other relevant regulatory requirements.
      • Experience in oncology clinical trials is highly desirable.

    • Skills:

      • Proficient in clinical trial management systems and comfortable with technology.
      • Excellent communication, presentation, and interpersonal skills.
      • Strong attention to detail and critical thinking abilities.

    • Language:

      • Fluent in Turkish and proficient in English.

    • Travel:

      • Must be willing to travel up to 75% within Turkey.

    Get to Know Syneos Health

    In the last five years, Syneos Health has worked on 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites, enrolling more than 675,000 trial patients.

    No matter your role, you will have the opportunity to challenge the status quo and contribute to meaningful change in a fast-paced, evolving industry.

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