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Cra2 Or Sr Cra

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 Senior Clinical Research Associate I (Sr. CRA I) position at Syneos Health:


About Syneos Health

Syneos Health is a global biopharmaceutical solutions organization dedicated to advancing clinical development, medical affairs, and commercial services. With a mission to simplify and accelerate therapeutic innovation, Syneos Health fosters collaboration, diversity, and inclusivity across 29,000 employees in 110 countries.


Role Overview

The Senior Clinical Research Associate I (Sr. CRA I) manages and monitors clinical trial site activities to ensure compliance with protocols, regulations, and Good Clinical Practice (GCP). The role includes mentoring junior staff, operational leadership tasks, and supporting site relationships throughout the study lifecycle.


Key Responsibilities

  • Site Management: Conduct site qualification, initiation, monitoring, and close-out visits. Evaluate site performance and escalate issues as necessary.
  • Compliance & Data Integrity: Ensure informed consent processes, subject safety, and data integrity align with ICH-GCP and local regulations.
  • Documentation & Reporting: Prepare trip reports, communication logs, and essential documents. Enter updates in tracking systems to monitor progress and resolve actions.
  • Investigational Product (IP) Oversight: Verify IP storage, reconciliation, and protocol-compliant dispensation.
  • Audit Preparation: Support sites in maintaining audit readiness and managing follow-up actions.
  • Training & Mentorship: Provide guidance to junior CRAs, conduct training visits, and assist with operational tasks under supervision.
  • Real-World Late Phase (RWLP) Studies: Develop informed consent forms, perform chart abstraction, collect data, and ensure adherence to local regulatory guidelines.

Additional Responsibilities

  • Collaborate with sponsors, affiliates, and medical science liaisons to optimize site engagement and study outcomes.
  • Identify operational efficiencies and process improvements for study delivery.
  • Participate in bid defense meetings to support project acquisition efforts.

Qualifications

  • Education: Bachelor’s degree or RN equivalent in a related field.
  • Experience: Proficiency in GCP/ICH guidelines and clinical trial monitoring.
  • Skills: Strong communication, critical thinking, and technological adaptability.
  • Travel Requirement: Up to 75% travel required on a regular basis.

Why Join Syneos Health?

  • Development Opportunities: Comprehensive career growth pathways with technical and therapeutic training.
  • Inclusive Culture: Commitment to diversity and authentic self-expression within the workplace.
  • Global Leadership: Collaboration on innovative therapies, including 94% of FDA-approved drugs in the past five years.

Additional Information

This role involves tasks beyond the listed responsibilities as required by the project or company. Syneos Health is an equal opportunity employer committed to compliance with the ADA and providing reasonable accommodations to employees and applicants.

For more details about Syneos Health and its innovative approach, visit their careers page or contact their team.