[Remote] Senior Clinical Research Specialist

Note: The job is a remote job and is open to candidates in USA. Merit Medical is focused on creating innovative medical devices that improve lives. They are seeking a Senior Clinical Research Specialist to manage trial master files, maintain regulatory documents, and support clinical trials while ensuring compliance with regulations and guidelines.ResponsibilitiesSets up and maintains trial master file and is responsible for filing and maintaining up to date study documentsMaintains multiple trackers following the progress of assigned clinical trials, such as essential documents, investigational product, trial supplies and study follow-up visits, as applicableOrders, prepares, and sends documents and materials to clinical trial sites and vendors as needed (electronic and paper)Provides support to study vendorsCollects and reviews all regulatory documents for accuracy and compliance to departmental SOPs, local and national regulations and guidelinesFollows up as required to resolve deficienciesEnsures that regulatory documents are maintained and updated in a timely and appropriate mannerEnsures study team training records are kept currentPerforms in-house duties to assist monitors, e.g., outstanding action itemsManages central IRB submissions and supports sites in IRB/EC submissionsMay attend site visits to assist monitors, when applicableAssists with the development of study and site toolsContributes to clinical site interactions, including enrollment and subject visit updates, clinical trial material and clinical supply requests, issue resolution, etcAssists in developing and overseeing study operational plan(s) as applicable (e.g., TMF plan)Contributes to study team for trial start-up, conduct, and close-out activities according to industry and departmental standardsConducts study systems training(s)Contributes to creation of study documentation including informed consent, newsletters, etcProvides general support to the Clinical Affairs team and project team(s), including meeting agendas, minutes and management of translationsAssists Project Managers with invoice receipt and review as applicablePerforms other duties and tasks, as requiredSkillsEducation and/or experience equivalent to a Bachelor's Degree in a scientific discipline or nursing qualificationA minimum of six (6) years of related work experienceCurrent Good Clinical Practice (GCP) certificationKnowledge of US regulations, Good Clinical Practice and ICH guidelinesDemonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programsClinical trial experienceMedical Device clinical trial experienceBenefitsMultiple Shifts and Hours to choose from: Days, Swing (Eve), and NightsMedical/Dental & Other Insurances (eligible the first of month after 30 days)Low Cost Onsite Medical ClinicTwo (2) Onsite CafeteriasEmployee Garden | Gardening Classes3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays401K | Health Savings AccountCompany OverviewMerit Sensor designs and manufactures MEMS pressure sensors for various industries, including medical, industrial, and automotive. It was founded in 1991, and is headquartered in South Jordan, Utah, USA, with a workforce of 51-200 employees. Its website is https://meritsensor.com.