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Cra Ii/Sr Cra (Poland) - Sponsor-Dedicated

2+ years
Not Disclosed
10 Nov. 6, 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/Sr CRA – Sponsor-dedicated
Company: Syneos Health®
Location: [Insert Location or specify remote work]


About Syneos Health:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success. By translating unique clinical, medical affairs, and commercial insights into outcomes, we address modern market challenges. With a focus on simplifying and streamlining our work, Syneos Health strives to be the easiest organization to collaborate with and the best place to work.

As a global team of problem solvers, we’re dedicated to driving innovation and helping our customers achieve their goals faster. Join us as we deliver life-changing therapies to patients across the world.

Why Syneos Health?

At Syneos Health, we are deeply committed to career development, employee engagement, and a Total Self culture, where you can be your authentic self. Our diverse and inclusive environment encourages collaboration, growth, and recognition. We focus on building a company we all want to work for—one that values different perspectives and experiences, making us stronger and more innovative.


Job Responsibilities:

Regulatory Compliance & Site Management:

  • Ensure compliance with regulatory, ICH-GCP, and protocol standards at study sites.
  • Evaluate site performance, assess risks, and provide actionable recommendations.
  • Immediately communicate and escalate critical issues to the project team, creating action plans for resolution.
  • Oversee the informed consent process and ensure patient confidentiality at all times.

Monitoring & Data Management:

  • Conduct on-site and remote monitoring activities as per Clinical Monitoring/Study Monitoring Plan (CMP/SMP).
  • Perform Source Document Review and Source Data Verification (SDV), ensuring data integrity and accuracy in case report forms (CRFs).
  • Resolve data queries, verify data completeness, and follow up on protocol deviations.
  • Ensure proper documentation of site activities, including monitoring reports, communication logs, and follow-up letters.

Investigational Product (IP) Management:

  • Manage IP inventory and ensure proper dispensing, administration, and security per the protocol.
  • Ensure compliance with local regulations regarding blinded or randomized information related to IP.

Team & Site Collaboration:

  • Act as a liaison between study site personnel and internal project teams.
  • Assist with training site staff to ensure compliance with study protocols and regulatory requirements.
  • Collaborate with the Site Manager to manage site operations and maintain training and delegation logs.

Audit & Compliance Preparation:

  • Assist with site audit preparation and audit readiness at both the site and project levels.
  • Provide guidance on audit standards and facilitate corrective actions following audits.

Travel & Site Visits:

  • Ability to travel up to 75% regularly to monitor sites and perform study-related activities.

Qualifications:

  • Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
  • Strong understanding of Good Clinical Practice (GCP), ICH guidelines, and other regulatory requirements.
  • Proficient with computer systems and a willingness to embrace new technologies.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage up to 75% travel on a regular basis.

Why Work at Syneos Health?

  • Syneos Health has partnered with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products.
  • With over 200 studies across 73,000 sites and 675,000 trial patients, we are proud of our global reach and impact.
  • We offer a competitive benefits package, including health insurance, retirement planning, wellness programs, and more.

Join us at Syneos Health, where work matters everywhere. Learn more about us and apply today at our Careers Page.