The CTA provides broad support to the Clinical Operations team and assists in operational delivery of clinical studies.
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.
- Participate in projects / initiatives on request or take on department-wide tasks to contribute to the optimization of processes within the department.
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.
Preferred Education and Experience:
- BA/BS (preferred but not required)
- Minimum 1 to 2 years CTA experience
- Previous biopharmaceutical clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO.
Required Knowledge, Skills, Abilities & Behaviors:
- Excellent oral and written communication skills, attention to detail and ability to interact effectively with internal management and various levels of external partners.
- Ability to manage multiple priorities and responsibilities.
- Working knowledge of FDA regulations/guidelines, ICH guidelines and GCPs.
- Demonstrate understanding of trial and protocol objectives.
- Strong working knowledge of MS Office and Outlook.
- Proficient with Veeva eTMF (preferred but not required).
- Due to COVID, employees are required to work remotely but will transition back to a professional office environment.
- This role routinely uses standard office equipment such as computers, phones, and photocopiers.
- This position is required to work occasional nights and weekends to meet company demands.
- Occasional overnight travel to investigator sites or Site Initiation Meetings may be required.
The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end, and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants for open positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.