Senior Clinical Research Specialist

This is a fully remote position, open to applicants in Utah.

📋 Description

• Establishes and manages the trial master file while ensuring that study documents are filed and kept current.

• Maintains various trackers that monitor the progress of assigned clinical trials, including essential documents, investigational products, trial supplies, and study follow-up visits, as applicable.

• Orders, prepares, and dispatches documents and materials to clinical trial sites and vendors as necessary (both electronic and paper formats).

• Provides assistance to study vendors.

• Gathers and reviews all regulatory documents to ensure accuracy and compliance with departmental SOPs, as well as local and national regulations and guidelines.

• Follows up as needed to address any deficiencies.

• Ensures that regulatory documents are maintained and updated in a timely and appropriate manner.

• Ensures that training records for the study team are kept up to date.

• Performs in-house duties to support monitors, such as managing outstanding action items.

• Manages central IRB submissions and assists sites with IRB/EC submissions.

• May participate in site visits to support monitors, when applicable.

• Aids in the development of study and site tools.

• Engages in clinical site interactions, which include enrollment updates, subject visit updates, requests for clinical trial materials and clinical supplies, issue resolution, and more.

• Assists in the creation and oversight of study operational plans as necessary (e.g., TMF plan).

• Contributes to the study team for trial start-up, execution, and close-out activities in line with industry and departmental standards.

• Conducts training sessions on study systems.

• Assists in the creation of study documentation, including informed consent forms, newsletters, and more.

• Provides general support to the Clinical Affairs team and project teams, including managing meeting agendas, minutes, and translations.

• Aids Project Managers with the receipt and review of invoices as needed.

• Performs additional duties and tasks as required.

⛳️ Requirements

• Education and/or experience equivalent to a Bachelor's Degree in a scientific discipline or nursing qualification.

• A minimum of six (6) years of relevant work experience.

• Current Good Clinical Practice (GCP) certification.

• Knowledge of US regulations, Good Clinical Practice, and ICH guidelines.

• Proven computer skills, preferably in spreadsheets, word processing, databases, and other relevant software applications.

• Experience with clinical trials.

🏝️ Benefits

• Medical/Dental & Other Insurances (eligible the first of the 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.