Clinical Research Assoc

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. **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**: - Coordinate and manage 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. - Provide all job-related progress reports and visit documentation as required. - May support safety activities such as narrative writing, managing the CEC/DSMB, etc. - OUS: Prepares and coordinates submissions to regulatory authorities. - May perform other activities as assigned. - Assess the suitability of potential investigative sites through screening interviews, regulatory document review and evaluation of study information and provides input to the site selection process. - Assist with the coordination of the site budget and contract negotiations as directed by the project lead(s). - Assist in preparing sites for audits and in resolving audit action items. - Support sites during audits remotely and/or onsite as needed. - Participate in meetings with prospective clients. - Support training and mentoring of CRAs during remote and onsite visits. - Manage the development and/or maintenance of study monitoring plan, templates, trackers, study tools, and site-specific documents. - Assist Clinical Study Manager (CSM) with development of human clinical protocol, investigational plan/brochure, SIV training presentations, and study operations development. - Support Core Laboratory management and may serve as the primary contact. - Support data management in CRF development, validation rules, UAT, review data and identify trends, and other reporting/analysis tasks. - Perform and summarizes literature search