Clinical Research Associate 4

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Position Summary

The Clinical Research Associate 4 (CRA 4) provides advanced oversight and leadership in the execution of clinical trials. This role ensures adherence to ICH/GCP guidelines, regulatory requirements, company SOPs, and study protocols while guiding the successful management of U.S. clinical studies or designated components of larger global programs. As an experienced clinical operations professional, the CRA 4 leads cross‑functional collaboration, manages CROs and vendors, and supports the development of key study documents and processes.

 

The Clinical Research Associate 4 may provide guidance and oversight for the successful management of all aspects of smaller U.S. studies and/or work with study manager to provide oversight and guidance of specific areas of larger studies.

 

Key Responsibilities

Study Oversight & Execution

• • Provide leadership and oversight for all operational aspects of assigned clinical studies.
  • Draft and coordinate review of protocols, informed consent forms, case report forms, monitoring plans, and investigator brochures.
  • Maintain study timelines and ensure milestones are met.
  • Lead meetings and conference calls with CROs, vendors, and cross‑functional teams.
  • Manage CROs and vendors, including performance oversight and issue resolution.
  • Contribute to development of site and study budgets, RFPs, and vendor selection.

 

Monitoring & Site Management

• • Monitor and/or co‑monitor clinical sites as needed to ensure study integrity and compliance.
  • Train CRO staff, vendors, investigators, and study coordinators on study requirements.
  • Review data listings and support preparation of interim and final clinical study reports.
  • Ensure proper documentation, including monitoring reports, follow‑up letters, and site correspondence.

 

Cross‑Functional Collaboration

• • Serve as a functional lead interacting with data management, safety, regulatory, and other internal groups.
  • Support risk management planning and contribute to continuous improvement of study processes.

 

Documentation & Quality

• • Ensure high‑quality documentation and adherence to regulatory and SOP requirements.
  • Support audit and inspection readiness activities.
  • Oversee distribution and tracking of study drug and clinical supplies.

 

Required Knowledge, Skills, and Abilities

• Advanced knowledge of medical terminology, clinical trial processes, regulatory requirements, and ICH/GCP.
• Strong verbal and written communication skills.
• Ability to train and mentor junior CRAs and external partners.
• Ability to work independently and collaboratively across functions.
• Strong decision‑making, prioritization, and organizational skills.
• Proficiency with MS Office Suite, EDC systems, and CTMS platforms.
• Willingness and ability to travel.

 

Education Requirements

• Associate’s degree in a life science field required.
• Bachelor’s degree in a life science field preferred.

 

Experience Requirements

• Typically requires 8 years of experience in clinical research, including:
  • Minimum 3 years of field monitoring experience
  • Minimum 4 years in a lead CRA role

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Occupational Demands

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.   Occasionally walks and stands. Occasionally bends and twists neck.  Light to moderate lifting