Instagram
youtube
Facebook

Cra Ii Madrid

2+ years
Not Disclosed
10 Sept. 27, 2024
Job Description
Job Type: 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

About Syneos Health

Syneos Health® is a leading integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform unique clinical, medical affairs, and commercial insights into outcomes that address the complexities of modern markets. Our Clinical Development model places both the customer and the patient at the forefront of everything we do, continually seeking to simplify processes and enhance collaboration.

Why Work at Syneos Health?

We are committed to the development of our employees through career progression, supportive management, technical training, and recognition programs. Our Total Self culture promotes authenticity and unites us globally, ensuring that everyone feels a sense of belonging. We strive to create an environment that reflects diverse thoughts, backgrounds, and perspectives.

Key Responsibilities

  • Site Management: Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely) to ensure compliance with regulatory standards, ICH-GCP guidelines, and study protocols. Evaluate site performance and escalate serious issues to the project team while developing action plans.

  • Informed Consent: Ensure that the informed consent process is conducted and documented correctly, safeguarding patient confidentiality and assessing factors impacting patient safety and data integrity.

  • Monitoring Activities: Execute tasks as per the Clinical Monitoring/Site Management Plan, including:

    • Assessing site processes.
    • Conducting source document reviews and verifying data accuracy in case report forms (CRFs).
    • Utilizing query resolution techniques to drive issues to closure.
    • Ensuring compliance with electronic data capture requirements.
  • Investigational Product Oversight: Manage investigational product inventory and verify compliance with protocols regarding dispensing, labeling, and security.

  • Documentation: Maintain accurate records of activities through confirmation letters, trip reports, and tracking systems to monitor project status and action items.

  • Project Coordination: Understand project scope, budgets, and timelines, managing site-level communications to meet project objectives. Adapt to changing priorities as necessary.

  • Liaison Role: Act as the primary contact with study site personnel, ensuring compliance and training for project-specific requirements.

  • Meetings and Training: Prepare for and attend Investigator Meetings and project staff meetings, participating in relevant clinical training sessions.

  • Audit Readiness: Provide guidance for audit preparedness and ensure compliance with applicable standards.

  • Real World Late Phase Responsibilities: For this phase, take on the role of Site Management Associate II, providing site support throughout the study lifecycle, conducting chart abstractions, and collaborating with local teams.

Qualifications

  • Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
  • Strong knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
  • Proficient in computer skills and open to new technologies.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage regular travel of up to 75%.

Discover Syneos Health

In the last five years, we have collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, working on over 200 studies across 73,000 sites with over 675,000 trial patients. Join us to take initiative and challenge the status quo in a fast-paced, competitive environment.

Additional Information

This job description is not exhaustive and may be subject to change at the company’s discretion. Equivalent experience, skills, and education will also be considered. Syneos Health is committed to compliance with all applicable employment laws, including the provision of reasonable accommodations for individuals with disabilities.