Senior Clinical Research Specialist

Work Shift: DAY

• 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.

• 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.

• Verbal and written communication.
• Organization.
• Detail‑oriented.
• Project task team participation.

Employees are not expected to come into contact with blood or body fluids while performing their jobs; risk category III.

Military Veterans are encouraged to apply. Merit is a proud Utah Patriot Partner committed to hiring our Veterans.

Benefits available for eligible employees: multiple shifts and hours to choose from; medical/dental and other insurances (eligible the first of month after 30 days); low‑cost onsite medical clinic; two onsite cafeterias; employee garden and gardening classes; 3 weeks vacation, 1 week sick‑time, paid holidays; 401K and health savings account.