Instagram
youtube
Facebook

Senior Cra Ii - Must Have Early Phase Neurology Expereince - Sponsor Dedicated - Bulgaria (Homebased

2+ years
Not Disclosed
10 Nov. 13, 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

Senior Clinical Research Associate II - Syneos Health®

Syneos Health® is a global leader in fully integrated biopharmaceutical solutions, committed to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to create impactful outcomes that address modern market challenges. Our Clinical Development model places the customer and patient at the center of everything we do, fostering innovation and teamwork to help our clients achieve their goals.

Why Join Syneos Health?
At Syneos Health, we focus on developing our people through career progression, training, recognition programs, and a culture where authenticity is valued. Our Total Self culture celebrates diversity and inclusion, and we are committed to creating a workplace where everyone feels they belong. Join us and be part of an organization that values your contributions and is dedicated to driving global healthcare innovation.

Key Responsibilities:

  • Perform site qualification, initiation, monitoring, management, and close-out visits (either on-site or remotely) ensuring compliance with regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practices (GPP).
  • Evaluate site performance, providing recommendations, escalating critical issues, and developing action plans as necessary.
  • Ensure informed consent is properly documented and protect patient confidentiality.
  • Conduct Source Document Review and verify case report form (CRF) accuracy by reviewing site records.
  • Resolve data queries and ensure compliance with electronic data capture requirements.
  • Oversee investigational product (IP) inventory and ensure proper handling and reconciliation.
  • Manage Investigator Site Files (ISF) for completeness and accuracy, ensuring proper document archiving.
  • Document site monitoring activities and communicate follow-ups to ensure timely issue resolution.
  • Act as the primary liaison with study site personnel, ensuring adherence to study protocols and regulatory requirements.
  • Provide mentorship and training to junior Clinical Research Associates (CRAs) and participate in audit preparation and follow-up activities.
  • For Real World Late Phase (RWLP), provide site support, engage in chart abstraction, and collaborate with stakeholders to enhance operational efficiency.

Qualifications:

  • Bachelor’s degree or RN in a related field, or equivalent education and experience.
  • In-depth knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements.
  • Proficiency in new technologies and excellent computer skills.
  • Strong communication, presentation, and interpersonal skills.
  • Ability to manage up to 75% travel.

About Syneos Health: With a rich history of working with novel FDA-approved drugs, EMA-authorized products, and clinical trials across a global network, Syneos Health drives medical advancements. Join us to make a difference in accelerating the delivery of life-changing therapies.

Explore a career at Syneos Health and be part of a mission-driven team that's redefining what success in healthcare means.