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Sr Cra I Barcelona Or Madrid. Experience In Neurology. Sponsor Dedicated.

2+ years
Not Disclosed
10 Dec. 13, 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 Description
Senior Clinical Research Associate I

Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical, medical affairs, and commercial insights, we deliver innovative solutions to address evolving market demands.

Our Clinical Development model places both the customer and the patient at the center of all that we do. By continuously simplifying and refining our processes, we aim to make Syneos Health not only easier to work with but also an exceptional place to build your career.

With over 29,000 employees in 110 countries, discover why Work Here Matters Everywhere.


Why Syneos Health?

  • People Development: We focus on career growth through development programs, supportive management, and opportunities for advancement.
  • Inclusive Culture: Our Total Self culture encourages employees to bring their authentic selves to work, fostering diversity and belonging.
  • Innovative Environment: We prioritize collaboration, inclusion, and innovation to create a workplace our employees and clients value.

Your Role

As a Senior Clinical Research Associate I, you will perform a variety of essential site management and monitoring responsibilities across the clinical trial lifecycle. This includes ensuring regulatory compliance, upholding ethical standards, and supporting sites through qualification, initiation, monitoring, and closure activities.

Primary Responsibilities

  • Conduct site visits (on-site and remote) for qualification, initiation, interim monitoring, and close-out, ensuring adherence to ICH-GCP, regulatory requirements, and protocol compliance.
  • Verify that informed consent is properly obtained and documented, maintaining patient confidentiality and data integrity.
  • Assess site processes and perform source document reviews to ensure the accuracy of data and protocol adherence.
  • Resolve queries, provide site staff guidance, and ensure timely data capture and issue resolution.
  • Verify investigational product (IP) management, including inventory, storage, dispensing, and compliance with protocol and regulations.
  • Review Investigator Site Files (ISFs) for accuracy, reconcile with Trial Master Files (TMFs), and ensure archiving compliance.
  • Document activities through confirmation letters, follow-ups, and trip reports as per clinical monitoring plans.
  • Support patient recruitment and retention efforts and enter data into tracking systems to monitor status and resolve actions.

Additional Responsibilities

  • Participate in Investigator Meetings and clinical team sessions.
  • Provide site-level guidance for audit readiness and assist with preparation and follow-up.
  • Offer training and mentorship to junior CRAs as assigned.
  • Engage in operational efficiencies, process improvements, and informed consent development.
  • Collaborate with regulatory teams, sponsors, and affiliates, and participate in bid defense meetings.

Qualifications

  • Education: Bachelor’s degree or RN in a related field; equivalent education/experience will be considered.
  • Experience:
    • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
    • Familiarity with late-phase study designs and real-world evidence collection.
  • Skills:
    • Strong computer proficiency and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage up to 75% travel and adapt to changing priorities.

Why You’ll Love Syneos Health

  • Innovation in Action: We’ve partnered on 94% of all FDA-approved drugs over the past five years.
  • Global Impact: Collaborate with 73,000+ sites and 675,000+ trial patients worldwide.
  • Commitment to Diversity: We foster an inclusive workplace, where unique perspectives drive progress.

Not Ready to Apply?
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At Syneos Health, we value transferrable skills and encourage applicants from diverse backgrounds to apply, even if they don’t meet all listed qualifications.