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Sr Cra I (Sponsor Dedicated) Denmark

2+ years
Not Disclosed
10 Dec. 2, 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 Title: Senior Clinical Research Associate I (Sr. CRA I)

Department: Clinical Operations
Reporting To: Lead CRA/Clinical Operations Lead (COL)


Role Overview:

The Senior Clinical Research Associate I (Sr. CRA I) plays a pivotal role in managing clinical trial site activities and ensuring compliance with regulatory standards, Good Clinical Practice (GCP), and study protocols. This role encompasses site qualification, monitoring, and close-out, in addition to mentoring junior CRAs and contributing to process improvements and project scope management.


Key Responsibilities:

Site Management and Monitoring:

  • Conduct site qualification, initiation, interim monitoring, and close-out visits on-site or remotely, ensuring protocol and regulatory compliance.

  • Evaluate site and staff performance, escalating significant issues and developing corrective action plans as needed.

  • Oversee informed consent processes and safeguard patient confidentiality.

  • Monitor site compliance with investigational product (IP) handling and storage requirements.

Data Integrity and Documentation:

  • Verify clinical data accuracy and completeness through source document review and case report form (CRF) verification.

  • Manage electronic data capture (EDC) compliance and resolve data queries promptly.

  • Maintain and reconcile Investigator Site File (ISF) with the Trial Master File (TMF).

  • Document site activities through confirmation letters, trip reports, and tracking systems.

Mentorship and Training:

  • Provide mentorship and training to junior CRAs, including performing sign-off visits as assigned.

  • Lead training sessions and global clinical monitoring meetings, supporting junior staff development.

Project Management:

  • Collaborate with site teams to meet project timelines, deliverables, and budgetary goals.

  • Support project-level audit readiness and assist with audit preparations and follow-ups.

  • Identify and address out-of-scope activities, proposing process improvements and operational efficiencies.

Real World Late Phase (RWLP) Support:

  • Manage site operations throughout the study lifecycle, including site identification and close-out.

  • Conduct chart abstraction and data collection for real-world evidence.

  • Develop and maintain country-specific informed consent forms in collaboration with the regulatory team.

  • Build relationships with sponsor affiliates, medical science liaisons, and local teams.

Advanced Contributions:

  • Participate in bid defense meetings, offering insights into site selection and operational strategy.

  • Act as a primary liaison with project site personnel, ensuring compliance and clear communication.


Qualifications:

Education and Experience:

  • Bachelor’s degree or RN qualification in a related field, or equivalent education/training and experience.

  • Strong understanding of GCP, ICH Guidelines, and applicable regulatory requirements.

Skills and Competencies:

  • Proficient in computer systems and adaptive to new technologies.

  • Excellent communication, presentation, and interpersonal skills.

  • Demonstrated critical thinking and problem-solving abilities.

  • Capability to travel up to 75% regularly.


Why Join Syneos Health?

  • Career Development: Extensive opportunities for growth, training, and mentorship.

  • Inclusive Culture: A Total Self culture promoting diversity, authenticity, and belonging.

  • Industry Impact: Collaborate on projects involving groundbreaking therapies and real-world evidence.


Additional Information:

  • Responsibilities and qualifications are subject to company discretion and adjustment.

  • Syneos Health complies with all relevant regulations, including providing reasonable accommodations under the Americans with Disabilities Act (ADA).

Join us to make a meaningful impact— Work Here Matters Everywhere.