Description
IQVIA Biotech is seeking a Clinical Research Associate to work remotely in Spain. The successful candidate will have varied therapeutic experience and be willing to work across multiple therapeutics, including Oncology, Hematology, and Cardiovascular.
Essential Functions
- Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
- Ensure copies/originals of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
- Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans
- Collaborate and liaise with study team members for project execution support as needed
Qualifications
- Bachelor's degree in a scientific discipline or healthcare preferred
- At least 1.5 years of on-site monitoring experience
- Equivalent combination of education, training, and experience may be accepted
- Organizational, time management, and problem-solving skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Flexibility to travel
- Driver's license