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Clinical Research Associate
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Description :About NAMSA :NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.Come and work for an organization with the:> Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the-> Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core-> Values:Act with integrity in everything we do.Provide best-in-class customer experiences.Develop superior talent and deliver expertise.Respond with agility and provide timely results.Embrace collaboration, diverse perspectives and ideas.Your responsabilities :• Work on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.• Coordinate and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.• May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.• Serve as primary point of contact for site questions relating to study enrolment, conduct, and close-out issues: liaise with appropriate study team members as needed.• Communicate through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.• Support study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.• Perform study-related training.• Manage the development and maintenance of study documents, processes and systems as assigned.• Ensure quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.• Track study site and over all study metrics including but not limited to enrolment, deviations, adverse events, trial master file maintenance.• Attend internal and external meetings as required.• Provides all job-related progress reports and visit documentation as required.• May support safety activities such as narrative writing, managing the CEC/DSMB, etc.• Prepare and coordinate submissions to regulatory authorities.• May perform other activities as assigned.Working conditions :• Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates.• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Your qualifications :• Bachelor or Master’s degree/PhD.• Preferred 2-3 years clinical trial experience.• Experience in monitoring and able to work independently.• Able to speak a Professional Dutch, English and French/German.• Good verbal and written communication skills.• Strong organizational skills.• Computer proficiency.• Understanding of clinical research processes and regulations.• Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required.
