Are you an experienced CRA in Medical Devices, based in Spain and speaking French? Are you interested in an international CRA role covering broad CRA tasks? Don't hesitate and apply today!
Job Description
As a CRA, you will support the Clinical study team in the execution of clinical studies to assess the safety and effectiveness of specific Medical Devices products.
Responsibilities
- Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
- Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
- May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
- Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
- Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
- Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
- Performs study-related training.
- Manages the development and maintenance of study documents, processes and systems as assigned.
- Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
- Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
- Attends internal and external meetings as required.
- Provides all job-related progress reports and visit documentation as required.
- May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
- Prepares and coordinates submissions to regulatory authorities.
- May perform other activities as assigned.
Requirements
- Fluency in English, Spanish and French.
- Medical Devices experience.
- Monitoring experience.
- Experience in submissions to regulatory authorities.
- Higher education degree or equivalent education, training, and experience.
- Understanding of clinical research processes and regulations.
- Able to work independently once trained.
- Good verbal and written communication skills.
- Strong organizational skills.
- Basic computer proficiency.
- Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required.
Benefits
- Long term project.
- Payroll / Freelance.
- Travel up to 80%.
