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Sr Cra I Home-Based In Barcelona Preferably. Sponsor Dedicated

2+ years
Not Disclosed
10 April 25, 2025
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 Title: Senior Clinical Research Associate I (Home-Based, Barcelona Preferred)
Location: Spain (Home-Based - Madrid or Barcelona Preferred)
Job ID: 25003329


About Syneos Health:
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. With 29,000 employees across 110 countries, we deliver unique clinical, medical affairs, and commercial insights that drive real outcomes.

We are committed to simplifying and streamlining operations to enhance both client satisfaction and employee experience. Our mission: make Syneos Health a place where work truly matters everywhere.


Why Join Us:

  • Career development and progression opportunities

  • Supportive and engaged line management

  • Technical and therapeutic area training

  • Peer recognition and total rewards program

  • A culture of authenticity and inclusion through our Total Self initiative

  • Diversity and belonging are at the core of our work environment


Key Responsibilities:

  • Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote)

  • Ensure compliance with ICH-GCP, GPP, protocols, and regulations

  • Evaluate site performance, escalate issues, and propose site-specific action plans

  • Verify informed consent process and protect patient confidentiality

  • Conduct source document review, validate CRF entries, and ensure query resolution

  • Monitor investigational product (IP) inventory and compliance

  • Reconcile Investigator Site File (ISF) with Trial Master File (TMF)

  • Document activities and track site data

  • Collaborate with site staff, project teams, and Central Monitoring Associates

  • Support recruitment, retention, and awareness strategies

  • Train and mentor junior CRAs as assigned

  • Attend Investigator and sponsor meetings


Additional RWLP Responsibilities:

  • Support site lifecycle from identification to close-out

  • Engage in chart abstraction and data collection

  • Coordinate with sponsor affiliates and MSLs

  • Suggest potential sites using local treatment knowledge

  • Identify operational efficiencies

  • Develop country-specific ICFs

  • Participate in bid defense meetings


Qualifications:

  • Bachelor's degree or RN in related field, or equivalent experience

  • Solid understanding of GCP/ICH and regulatory guidelines

  • Proficiency in computer systems and willingness to adopt new technologies

  • Excellent communication and interpersonal skills

  • Travel availability up to 75%


Note:
This job description is not exhaustive and may evolve based on organizational needs. Syneos Health ensures compliance with local laws, including the EU Equality Directive and the Americans with Disabilities Act.