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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 who will help drive greenfield clinical activity for our client's novel technology, overseeing and managing clinical trials, and taking on advanced proctoring responsibilities. 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. 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. 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Other, and Science Industries
Medical Equipment Manufacturing
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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 who will help drive greenfield clinical activity for our client's novel technology, overseeing and managing clinical trials, and taking on advanced proctoring responsibilities. 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. 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. 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Other, and Science Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
