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Cra Ii - Must Have Immuno-Inflammation (Copd) Expereince - Sponsor Dedicated - Bulgaria (Homebased)

2+ years
Not Disclosed
10 Nov. 13, 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

Clinical Research Associate II | Syneos Health®

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We specialize in translating unique clinical, medical affairs, and commercial insights into tangible outcomes that address modern market challenges. Our Clinical Development model centers on both the customer and patient, aiming to simplify and streamline processes to make Syneos Health not only easier to work with but also easier to work for.

Why Work at Syneos Health? At Syneos Health, we prioritize the growth and development of our employees through career advancement opportunities, robust technical and therapeutic training, peer recognition programs, and a comprehensive total rewards package. Our Total Self culture fosters an environment where employees can authentically be themselves, contributing to a global, inclusive atmosphere where diverse thoughts, backgrounds, and perspectives are embraced.

Job Responsibilities:

  • Site Management: Perform site qualification, initiation, monitoring, and close-out visits, ensuring compliance with regulatory standards (ICH-GCP, GPP) and protocols. Use professional judgment to assess site performance and escalate serious issues when necessary.
  • Data Integrity: Verify informed consent, review clinical data entered into Case Report Forms (CRFs), and apply query resolution techniques both on-site and remotely.
  • Investigational Product (IP) Management: Oversee IP inventory, reconciliation, and ensure proper dispensing according to protocol, including adherence to GCP and local regulations.
  • Documentation and Compliance: Maintain accuracy in the Investigator Site File (ISF) and Trial Master File (TMF). Ensure that essential documents are archived in compliance with regulatory guidelines.
  • Site Support: Assist with site recruitment, retention, and awareness strategies while adhering to project scope, budgets, and timelines. Adapt quickly to changes in priorities to achieve project goals.
  • Collaboration: Act as a liaison between study site personnel and the project team, ensuring that sites are compliant with training and regulatory requirements. Participate in Investigator Meetings, clinical monitoring/project staff meetings, and clinical training sessions.
  • Audit Preparation: Provide guidance in audit readiness and assist with preparation and follow-up actions as required.
  • Real World Late Phase: For Real World Late Phase studies, perform site support activities, chart abstraction, and collaborate with local teams. Assist in training junior staff and proactively suggest potential sites.

Qualifications:

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

About Syneos Health: With over 29,000 employees across 110 countries, Syneos Health has been instrumental in supporting the development of 94% of all novel FDA-approved drugs, 95% of EMA authorized products, and over 200 studies across 73,000 sites globally. Joining Syneos Health means taking initiative and pushing boundaries in an ever-evolving, competitive environment.

Additional Information: The tasks and responsibilities listed above are not exhaustive. Syneos Health reserves the right to assign additional duties at its discretion. Equivalent experience and education will be considered for the role. All responsibilities comply with local, national, and global regulatory obligations.

Apply today and join us in making a global impact at Syneos Health!