Description
Syneos Health is seeking a Clinical Research Associate I to join their team in Barcelona or Madrid. The successful candidate will have a minimum of 1 year of experience in a CRA role and will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits.
The CRA I will use judgment and experience to evaluate the overall performance of site and site staff and provide recommendations regarding site-specific actions. They will also verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
- Evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient
- Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
- Develop and implement action plans to address any issues or concerns
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
Qualifications:
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
- Minimum of 1 year of experience in a CRA role
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis