Description
We are seeking a Senior Clinical Research Associate II (Sr CRA II) to join our team in Madrid. As a Sr CRA II, you will be responsible and accountable for site monitoring and site management for clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.
Summary of Responsibilities:
- Conduct routine monitoring and close-out of clinical sites, maintain study files, and perform pre-study and initiation visits
- Liaise with vendors and ensure the protection of study patients by verifying informed consent procedures and protocol requirements
- Ensure data integrity by reviewing source documents and monitoring data for missing or implausible entries
- Manage travel expenses efficiently according to Fortrea's travel policy
- Prepare accurate and timely trip reports and serve as lead monitor for a protocol or project
- Review project progress and initiate actions to achieve target objectives
- Organize presentations at Investigator Meetings and participate in protocol development and Case Report Form creation
- Act as contact for clinical trial supplies and registry management
- Conduct Quality Control visits and track Serious Adverse Event reporting
- Independently perform CRF review and query generation
- Assist with training and mentoring new employees
- Coordinate clinical projects as a Local Project Coordinator
Qualifications (Minimum Required):
- University or college degree in a related allied health profession, or equivalent experience
- Minimum 6 years of recent clinical monitoring experience, with 2 years in Oncology, Ophthalmology, and/or Gene Therapy
- Thorough knowledge of regulatory requirements and the drug development process
- Fluent in local office language (Spanish) and English, both written and verbal
Experience (Minimum Required):
- Five years of Clinical Monitoring experience, with 2 years in Oncology, Ophthalmology, and/or Gene Therapy
- Understanding of Serious Adverse Event reporting and good computer skills
- Ability to train and supervise junior staff, and prioritize workload
Physical Demands/Work Environment:
- Travel Requirement: Yes