Description
We are seeking a Clinical Research Associate to perform monitoring and site management work. As a Clinical Research Associate, you will ensure that sites are conducting studies and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Responsibilities:
- Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits
- Work with sites to adapt, drive, and track subject recruitment plans in line with project needs
- 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 completion and submission, and data query generation and resolution
- Ensure site documents are available for filing in the Trial Master File and verify that the Investigator's Site File is maintained in accordance with GCP/ICH 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 appropriate
Qualifications:
- Bachelor's degree in a scientific discipline or healthcare preferred
- 1+ year of on-site monitoring experience
- Good therapeutic and protocol knowledge
- IT literacy
- Excellent written and verbal communication skills, including good command of English and Hungarian language
- Strong organizational and problem-solving skills
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients