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.

Responsibilities

• Sets up and maintains trial master file and is responsible for filing and maintaining up to date study documents
• Maintains multiple trackers following the progress of assigned clinical trials, such as essential documents, investigational product, trial supplies and study follow-up visits, as applicable
• Orders, prepares, and sends documents and materials to clinical trial sites and vendors as needed (electronic and paper)
• Provides support to study vendors
• Collects and reviews all regulatory documents for accuracy and compliance to departmental SOPs, local and national regulations and guidelines
• Follows up as required to resolve deficiencies
• Ensures that regulatory documents are maintained and updated in a timely and appropriate manner
• Ensures study team training records are kept current
• Performs in-house duties to assist monitors, e.g., outstanding action items
• Manages central IRB submissions and supports sites in IRB/EC submissions
• May attend site visits to assist monitors, when applicable
• Assists with the development of study and site tools
• Contributes to clinical site interactions, including enrollment and subject visit updates, clinical trial material and clinical supply requests, issue resolution, etc
• Assists 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 standards
• Conducts study systems training(s)
• Contributes to creation of study documentation including informed consent, newsletters, etc
• Provides general support to the Clinical Affairs team and project team(s), including meeting agendas, minutes and management of translations
• Assists Project Managers with invoice receipt and review as applicable
• Performs other duties and tasks, as required

Skills

• Education and/or experience equivalent to a Bachelor's Degree in a scientific discipline or nursing qualification
• A minimum of six (6) years of related work experience
• Current Good Clinical Practice (GCP) certification
• Knowledge of US regulations, Good Clinical Practice and ICH guidelines
• Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
• Clinical trial experience
• Medical Device clinical trial experience

Benefits

• Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
• Medical/Dental & Other Insurances (eligible the first of month after 30 days)
• Low Cost Onsite Medical Clinic
• Two (2) Onsite Cafeterias
• Employee Garden | Gardening Classes
• 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
• 401K | Health Savings Account

Company Overview