Essential Duties and Responsibilities:
- Collecting, registering, and archiving information and documents in accordance with the applicable GCP guidelines for clinical studies and corresponding Aclaris Standard Operating Procedures.
- Maintenance of Trial Master File (TMF) and Investigator Site Files (ISF) to ensure regulatory compliance and audit readiness.
- Collection and tracking of regulatory documents for study start-up and IRB submissions; provide oversight of Contract Research Organization (CRO) managed studies to ensure these activities are completed.
- Assist in the preparation of study documentation forms, and the development of administrative and filing systems and processes.
- Accountable for the management of study materials and supplies - distribution, ordering, tracking, storage, reconciliation, and destruction.
- Assist in the planning, preparation, and presentation of Site Initiation Meetings.
- Maintain study contact list(s) for all clinical trial sites and vendors.
- Assist Clinical Operations in tracking study related activities.
- Assist in the preparation/review of study documents and communications for designated projects, including internal and external correspondence.
- Track the progress of clinical trial including patient recruitment, trial supplies and trial documentation.
- Track and process invoices and authorize clinical trial payments to selected vendors and investigational sites, accurately and in a timely manner.
- Organize and schedule appointments/meetings, internally and externally, as necessary and prepare meeting minutes.
- Complete assigned tasks in accordance with GCP, ICH guidelines and other regulatory requirements for clinical trial management.
- Other duties as assigned.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.