Job Description
Job DescriptionDescription:Job Description: Clinical Trial Administrator
The Clinical Trial Administrator (CTA) fulfils a specialized research role within the Clinical Research department. The CTA supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of a study. This role is responsible for preparing and maintaining Clinical Trial documentation and supervising administrative activities. In performing these duties, the CTA works closely with Clinical Research Associates to support and provide guidance on the administration of all related aspects of a clinical study.
The Clinical Trial Administrator is based in a Kerecis office and reports to the Director of Clinical Affairs.
Essential Functions
- Assist in the preparation and maintenance of clinical trial documentation
- Submit clinical trials to institutional review boards/ethics committees
- Cooperate with Clinical Trials Monitors
- Administrative activities
- Participate in Clinical Trials team meetings
- Conduct correspondence and make telephone contact with study sites
- Reporting ongoing progress to project manager(s)
- Mainten and report identified metrics
- Prepare other study materials, including but not limited to enrollment logs, drug/device accountability logs
- Prepare applicable submission forms and submit updated documents
- Establish and organize study files, including but not limited to study-specific source documentation, regulatory binders and other materials
- Assist principal investigator/site in communication
- Other tasks and responsibilities as assigned
Requirements:
Competencies
• Very good knowledge of the English language (enabling free verbal and written communication and understanding of content related to the field of clinical research)
• Conscientiousness, precision and consistency in carrying out assigned tasks
• High interpersonal skills
• Ability to work with a large team
• High level of motivation and commitment
• High organizational skills (setting priorities and managing multiple tasks)
• Openness to new challenges and willingness to continuously improve skills
• Knowledge of ICH GCP principles an asset
• Good knowledge of Microsoft Office suite
• Effective time management
• Communicativeness, ease in establishing contacts
Education & Experience
• Bachelor’s degree in science-related field preferred
• One to two years of experience as a clinical research coordinator
• Experience managing device or pharmacology trials or evidence of experience/education in clinical studies
Anticipated travel <5%.
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. Kerecis is an equal opportunity employer.