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

2+ years
Not Disclosed
10 Nov. 21, 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

Job Title: Clinical Research Associate II
Company: Syneos Health
Location: Remote/Various Locations (Travel Required)

About Syneos Health:
Syneos Health® is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. We bridge clinical, medical, and commercial insights to drive outcomes, with a focus on bringing the customer and patient to the center of everything we do. Whether working within Functional Service Provider partnerships or Full-Service environments, we collaborate as a team to innovate and support our customers in delivering impactful therapies.

Why Syneos Health:
At Syneos Health, we are passionate about developing our people through career progression, training, peer recognition, and a rewards program. We embrace our Total Self culture, where employees can be their authentic selves. Our commitment to diversity, empowerment, and accountability creates an inclusive environment where everyone feels they belong.

Role Overview:
We are seeking a Clinical Research Associate II (CRA II) to join our dynamic team. As a CRA II, you will be responsible for conducting site qualification, site initiation, interim monitoring, and site management activities, ensuring adherence to ICH-GCP and regulatory compliance. You will collaborate closely with site staff and project teams to ensure clinical trials are executed successfully and safely.

Job Responsibilities:

  • Perform site management activities, including qualification, initiation, monitoring, and close-out visits (on-site or remote).
  • Ensure compliance with ICH-GCP, local regulations, and study protocols.
  • Oversee the informed consent process and patient confidentiality at investigator sites.
  • Conduct Source Document Reviews and verify clinical data accuracy in case report forms (CRFs).
  • Resolve queries related to data and guide site staff in query resolution.
  • Monitor Investigational Product (IP) inventory and security, ensuring proper dispensing and handling according to protocol.
  • Maintain and reconcile Investigator Site Files (ISF) and Trial Master Files (TMF).
  • Support subject recruitment, retention, and awareness strategies.
  • Adapt quickly to project changes and manage site-level activities to meet objectives and timelines.
  • Ensure audit readiness and prepare sites for inspections.
  • In Real World Late Phase, manage sites from identification to close-out, including chart abstraction and data collection.

Qualifications:

  • Bachelor's degree or RN in a related field (or equivalent experience).
  • Strong knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
  • Proficiency with clinical monitoring, data review, and new technologies.
  • Excellent communication, organizational, and interpersonal skills.
  • Ability to travel up to 75% for site visits and project needs.

Get to know Syneos Health:
In the past 5 years, Syneos Health has worked on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, completing over 200 studies across 73,000 sites and more than 675,000 trial patients.

Apply Now: Syneos Health Careers