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Sponsor Dedicated Cra Ii - Home Based Portugal

2+ years
Not Disclosed
10 Dec. 5, 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

Here is a summary of the Sponsor Dedicated Clinical Research Associate II (CRA II) position at Syneos Health for Home-Based Portugal:


About Syneos Health

Syneos Health is a global biopharmaceutical solutions organization focused on accelerating customer success through integrated clinical, medical, and commercial services. With a mission to make therapeutic delivery more efficient, Syneos Health emphasizes collaboration, innovation, and inclusivity, with over 29,000 employees across 110 countries.


Role Overview

The Sponsor Dedicated Clinical Research Associate II (CRA II) is responsible for managing and monitoring clinical trial sites, ensuring regulatory compliance, and supporting study execution through site qualification, monitoring, and close-out visits. This role also involves mentoring junior staff and assisting with project-specific tasks.


Key Responsibilities

  • Site Management: Conduct site qualification, initiation, monitoring, and close-out visits, ensuring adherence to ICH-GCP, regulatory requirements, and study protocols. Escalate critical issues and develop action plans when necessary.

  • Informed Consent & Safety: Verify informed consent is properly obtained and documented. Assess and mitigate risks to patient safety and clinical data integrity.

  • Data & Documentation: Review source documents, case report forms (CRFs), and ensure accurate and complete data entry. Resolve queries and maintain compliance with electronic data capture systems.

  • Investigational Product (IP) Oversight: Ensure proper handling, dispensing, and storage of IP. Apply GCP and regulatory standards to IP labeling and distribution.

  • Audit Preparation: Ensure sites are audit-ready and support audit preparation activities.

  • Training & Mentorship: Provide guidance and training to junior CRAs. May assist with operational tasks under the supervision of project managers or leads.

  • Study Lifecycle Support: Oversee sites from initiation through close-out, support recruitment, retention strategies, and provide real-world data insights.

  • Site Support for RWLP: In Real World Late Phase studies, participate in chart abstraction, data collection, and collaborate with sponsors and local teams for study delivery.


Qualifications

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

  • Experience: Minimum 2 years of experience as a Clinical Research Associate.

  • Skills: Proficiency in GCP/ICH guidelines, clinical trial monitoring, and regulatory requirements. Strong communication, presentation, and interpersonal skills. Adaptability to new technologies.

  • Travel: Ability to manage up to 75% travel.


Why Join Syneos Health?

  • Career Development: Opportunities for professional growth through training, mentoring, and career advancement.

  • Inclusive Culture: A focus on authenticity, diversity, and belonging across the organization.

  • Innovative Work: Contribute to advancing therapies, with Syneos Health having worked on 94% of all FDA-approved drugs in the last five years.


Additional Information

The responsibilities listed are not exhaustive, and the company may assign other duties as needed. Syneos Health promotes a diverse and inclusive work environment and is committed to compliance with regulations such as the ADA.