Job Description

Our clinical-stage medical device company is adding a Clinical Trial Assistant to the team. This position represents an exciting opportunity to make an impact in early stages of clinical development for an innovative technology. As a member of the field team, the Clinical Trial Assistant is a professional who provides administrative support to clinical trials. Their primary role is to assist clinical research professionals, such as clinical research coordinators, study managers, and investigators, with the daily tasks involved in conducting clinical trials. The tasks may include preparing study documents, coordinating study meetings and site visits, communicating with study sites and vendors, managing study data, and ensuring regulatory compliance.

Desired Profile:

• Provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).
• Assist the Clinical Operations teams in completing all required tasks to meet departmental and project goals.
• Support the Clinical Operations teams with the ongoing conduct of studies.
• Ensure compliance with Good Clinical Practice (GCP), appropriate regulations, relevant Standard Operating Procedures (SOPs), and internal tracking systems.
• Assist project teams with study-specific documentation and guidelines.
• Set up, organize, and maintain clinical study documentation, including preparation for internal and external audits, final reconciliation, and archiving.
• Process Data Collection Forms, log in, track, and perform quality control as appropriate for the study.
• Perform quality control audits of clinical study documentation.
• Coordinate ordering, dispatch, and tracking of trial materials, such as CRFs, diary cards, lab supplies, and drug supplies, as appropriate.
• Assist project teams with trial progress tracking by updating the Clinical Trial Management System (CTMS).
• Copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.
• Assist in the coordination of Investigator payments, if applicable.
• Contact clinical sites for specific requests, such as enrollment updates, missing documentation, meeting arrangements, etc.
• Assist in the tracking and distribution of safety reports.
• Co-ordinate document translation, if required.
• Attend project team meetings and generate meeting minutes.
• Assist the Project Manager and project team with Investigator Meeting coordination, activities preparation, and generate meeting minutes.
• Assist in producing slides, overheads, etc., as needed for project, departmental, sponsor, and/or business development presentations.
• Assist with the coordination of team member tracking.
• Other duties as assigned.

Desired Profile:

• B.S. in Life Sciences, nursing, or equivalent.
• Minimum of 1 year of experience working directly with physicians and healthcare professionals in a medical device company

• Ability to present/teach detailed technical and clinical information, to all levels of customers.
• Excellent communication, presentation, analytical, interpersonal, and problem-solving skills.
• Proficiency in computer software, such as Microsoft Office and electronic data capture (EDC) systems
• Data analysis skills a plus.
• Excellent attention to detail and organizational skills.
• Time management and multitasking abilities.
• Familiarity with Good Clinical Practice, ISO and 21 CRF regulations pertaining to clinical research is a plus.

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