CRA

• Perform on-site and remote monitoring activities, including initiation, interim, and close-out visits, and generate accurate and timely visit reports.

• Verify adherence to scheduled visit intervals and timely generation of visit reports.

• Prepare and maintain the regulatory binder for clinical trials.

• Assist in preparing the electronic Case Report Form (eCRF) for studies.

• Attend sites during study days to assist with equipment setup and patient connection to the system.

• Provide on-site support to clinical teams, resolving issues as they arise.

• Coordinate communication between the company and the study coordinator, acting as the primary point of contact.

• Contribute to the design and development of clinical trial protocols.

• Participate in data collection and analysis activities, including researching, summarizing findings, and drawing conclusions.

• Writing and updating clinical regulatory documents such as CER, PMCF, SOPs

• Provide support for general tasks assigned by the Regulatory Affairs (RA) team.

Required Qualifications:

• Bachelor's degree in life sciences, healthcare, or a related field (master’s preferred).

• At least 7 years of experience in clinical research, as a CRA, in medical devices.

• Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial protocols.

• Excellent organizational and time-management skills.

• Strong communication and interpersonal skills, with the ability to coordinate across teams.

• Willingness to travel to clinical sites as needed.