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Cra Ii - Istanbul Based - Fsp

1+ years
Not Disclosed
10 Oct. 9, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Clinical Research Associate II

Location: Istanbul
Contract Type: Single Sponsor, Permanent

About Syneos Health:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to navigate modern market realities. Our Clinical Development model prioritizes both the customer and patient, focusing on streamlining processes to enhance collaboration and outcomes.

At Syneos Health, whether through Functional Service Provider partnerships or Full-Service engagements, you'll work alongside passionate problem solvers who innovate together to help our customers achieve their goals. Our agility drives the acceleration of therapy delivery, fueled by our commitment to changing lives.

Why Join Syneos Health?
We are committed to developing our people through career advancement opportunities, supportive management, specialized training, and a robust total rewards program. Our Total Self culture encourages authenticity, fostering an inclusive environment where diversity of thought, background, and perspective creates a sense of belonging.

Job Responsibilities:

  • Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely), ensuring compliance with regulatory standards, ICH-GCP, and Good Pharmacoepidemiological Practices (GPP).
  • Utilize judgment to evaluate site performance and staff, providing actionable recommendations and escalating serious issues as necessary.
  • Maintain up-to-date knowledge of ICH/GCP guidelines and company SOPs.
  • Verify that informed consent processes are properly executed and documented, safeguarding subject confidentiality.
  • Assess factors affecting subject safety and clinical data integrity, including protocol deviations and pharmacovigilance issues.

For the Clinical Monitoring/Site Management Plan (CMP/SMP):

  • Evaluate site processes and conduct Source Document Reviews of relevant site documentation and medical records.

  • Ensure accuracy and completeness of clinical data in case report forms (CRFs).

  • Implement query resolution techniques both remotely and on-site, guiding site staff to ensure timely closure of queries.

  • Utilize appropriate hardware and software to facilitate effective clinical project data review and capture.

  • Verify compliance with electronic data capture requirements.

  • Manage investigational product (IP) inventory and reconciliation, ensuring proper storage, security, and administration of IP according to protocol. Address any issues related to blinded or randomized information.

Qualifications:

  • A minimum of 12 months of clinical monitoring experience as a CRA.
  • Fluent in English (both spoken and written).
  • Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
  • Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.

If you’re ready to contribute to impactful clinical research and make a difference in patient outcomes, we encourage you to apply!