In recent decades treatment of heart attacks by minimally invasive percutaneous coronary intervention (PCI) has significantly improved the outcomes for patients. However, successful re-opening of the narrow or blocked coronary arteries does not always restore blood flow to the entire heart muscle.

Our client is developing a first in class medical device that will both diagnose MVO in real-time during PCI and serve as a treatment platform in the cath lab.

As they roll out their clinical trial across Europe, we are hiring a Senior Clinical Research Associate will help drive greenfield clinical activity for our clients novel technology, overseeing and managing clinica ltrials, and taking on advanced proctroing responsibiltites.

Responsibilities:

Proctoring and Case Support Duties

• Train assigned study staff on the correct use of the study device.
• Supervise/support the setup of the required site workflow to ensure study images and measurements are collected and of consistent quality.
• Maintain detailed proctoring records and documentation.
• Assist during live cases by supporting site staff
• In agreement with CPM, release clinical sites to independent use of the study device.
• Join occasional clinical cases to support safe and effective use of the study device.
• Clinical Trial Support.
• Manage clinical trial activities in alignment with the clinical project manager (CPM), from study initiation to close-out.
• Train and educate site staff on study CIP, the correct use of the study EDC software, the electronic Investigator Site File (eISF), and regulatory requirements.
• Conduct site qualification, initiation, monitoring, and close-out visits to ensure CIP adherence and data integrity.
• Collaborate with investigators and study site staff to resolve issues and ensure timely and accurate data collection.
• Work in close collaboration with CRO who manages the overall clinical study.

Regulatory Requirements Support

• Assist in the preparation IRB submissions and documents, as needed.
• Assist in internal and external audits and inspections at study sites, ensuring compliance with regulatory requirements.
• Data Management.
• Ensure accurate and timely data collection in eCRF, monitoring, and validation according to the CIP and associated documents.
• Collaborate with Data Management team to resolve data discrepancies with sites.

Qualifications:

• Bachelor’s degree in a relevant life science or healthcare field, master’s degree preferred.
• Relevant experience as Clinical Research Associate, Clinical Specialist or similar in the medical device or CRO industry.
• Good knowledge of GCP, ISO14155, ICH guidelines, and other relevant regulatory requirements.
• Proven experience in proctoring and site management preferred.
• Strong organizational skills and attention to detail.
• Good communication and interpersonal skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in using CTMS and EDC software solutions.