What are the responsibilities and job description for the Clinical Trial Assistant position at Precision Life Sciences?
We are seeking a Clinical Trial Assistant to be a key member of the Clinical Operations team, responsible for providing administrative and project support for the Clinical Department.
Primary Responsibilities:
- Assist with the auditing and reconciliation of all study-related documents for clinical trials
- Maintain version and quality control of study documentation and submit to Trial Master File
- Assist in the management and conduct quality review of the Trial Master File
- Track the progress of a clinical trial including patient recruitment, trial supplies, and trial documentation
- Accountable for the management of study materials and supplies - distribution, ordering, tracking, storage, reconciliation, and destruction
- Assist with the collection, review, and tracking of regulatory documents and safety data
- Follow established SOPs, ICH-GCP, and other applicable regulatory requirements across all tasks
- Coordinate logistics (including meeting set-up, agendas, and minutes) for the clinical project, program team, regulatory team, and clinical department meetings
- Track and qualify interested Investigators
- Generate and distribute internal and external newsletters
- Generate purchase orders and facilitate contract execution for the department
- Track and process invoices for the department
- Facilitate contract execution for the department
- Develop knowledge and expertise in Therapeutic Area
- Participate in required meetings and workshops
- Build the Sharepoint website and file structure for the department
- Assist with regulatory submissions
- Participate in required meetings and workshops
Competencies:
- Communicates effectively
- Action-oriented
- Tech-savvy
- Good problem-solving skills
Required Skills
- Excellent Microsoft Office skills
- Preferable experience using Microsoft Sharepoint
Education Requirements:
- Bachelor’s Degree: Preferably in a scientific area
- Knowledge of ICH-GCP Guidelines and other regulatory requirements of clinical trial management
- Preferably 2 years of biotechnology or pharmaceutical experience in CRO or sponsor setting
