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Cra Ii - Must Have Oncology Expereince - Sponsor Dedicated - Bulgaria (Homebased)

2+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Remote 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

Position: Clinical Research Associate II (CRA II)

Company: Syneos Health
Location: Global (with travel up to 75%)


About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization, dedicated to advancing therapies and improving lives. With a collaborative approach, we place customers and patients at the center of everything we do, ensuring innovation and streamlined processes for clinical development.


Responsibilities

As a CRA II, you will ensure regulatory compliance, data integrity, and site performance through effective monitoring and management of clinical trials.

Site Management & Monitoring:

  • Conduct qualification, initiation, monitoring, and close-out visits (on-site or remote).
  • Assess site compliance with ICH-GCP, protocol, and regulatory requirements.
  • Address protocol deviations, pharmacovigilance concerns, and site performance issues.

Data Verification & Documentation:

  • Review informed consent processes to protect subject confidentiality and safety.
  • Perform Source Document Reviews (SDR) and ensure data accuracy in CRFs.
  • Document findings through confirmation letters, follow-up reports, and trip summaries.

Investigational Product (IP) Oversight:

  • Verify storage, reconciliation, and dispensing of IPs align with protocol and GCP requirements.
  • Ensure compliance with labeling, import/export, and return standards.

Collaboration & Training:

  • Act as the primary liaison for study sites, sponsor affiliates, and internal teams.
  • Provide guidance and support for audits and training for site personnel.
  • Assist with recruitment, retention, and awareness strategies.

Real World Late Phase (RWL) Responsibilities:

  • Support site activities from identification to close-out.
  • Conduct chart abstraction and collaborate with local HCPs.
  • Mentor junior staff and suggest potential sites based on local expertise.

Qualifications

We seek motivated professionals with strong clinical research experience and the ability to thrive in a dynamic, fast-paced environment.

Education & Experience:

  • Bachelor's degree or RN in a relevant field (or equivalent experience).
  • Comprehensive knowledge of ICH/GCP guidelines and regulatory frameworks.

Skills:

  • Proficiency with new technologies and clinical research tools.
  • Strong communication, presentation, and interpersonal abilities.
  • Flexibility to travel up to 75% and adapt to shifting priorities.

Why Join Syneos Health?

A Culture of Inclusion:
Our Total Self culture encourages authenticity and values diversity, fostering an environment where everyone belongs.

Opportunities for Growth:

  • Career progression pathways tailored to your aspirations.
  • Therapeutic training and exposure to innovative clinical trials.

Global Impact:
Collaborate on transformative projects, including over 200 studies and 94% of novel FDA-approved drugs in the last five years.


Additional Information

This role offers exposure to diverse therapeutic areas, global project teams, and cutting-edge therapies. Syneos Health is committed to creating an inclusive workplace, providing reasonable accommodations to support all employees in achieving their best performance.

Interested?
Be part of a team that accelerates the delivery of life-changing therapies. Explore more at Syneos Health Careers.