Clinical Trials Document Specialist Ii
By Fred Hutch At Seattle, WA, United States
Minimum 3 years of document management experience.
5+ years of document management experience
Experience working with clinical electronic databases, preferably Medidata Rave
Experience in organizing documents for internal and external audits
Facilitate the design and development of data collection forms, instructions and procedures.
Develop and maintain flow diagrams developed to document coding processes around eligibility and randomization.

Are you looking for a challenging and rewarding career in clinical trials? We are seeking a Clinical Trials Specialist to join our team and help us develop and execute clinical trials that will make a difference in the lives of patients. If you have a passion for clinical research and a commitment to excellence, this could be the perfect job for you!

Overview A Clinical Trials Specialist is a professional who is responsible for the coordination and management of clinical trials. They are responsible for ensuring that the clinical trial is conducted in accordance with the protocol and applicable regulations. They are also responsible for the collection and analysis of data, and for the preparation of reports and presentations. Detailed Job Description A Clinical Trials Specialist is responsible for the coordination and management of clinical trials. This includes the development of protocols, the selection and recruitment of study participants, the collection and analysis of data, and the preparation of reports and presentations. The Clinical Trials Specialist is also responsible for ensuring that the clinical trial is conducted in accordance with the protocol and applicable regulations. Job Skills Required
• Knowledge of clinical trial protocols and regulations
• Excellent organizational and communication skills
• Ability to work independently and as part of a team
• Knowledge of data analysis and statistical methods
• Ability to manage multiple projects simultaneously
• Ability to work under pressure and meet deadlines
Job Qualifications
• Bachelor’s degree in a related field such as biology, chemistry, or health sciences
• Previous experience in clinical research or clinical trials
• Knowledge of Good Clinical Practice (GCP)
• Knowledge of medical terminology
• Knowledge of computer software programs such as Microsoft Office
Job Knowledge
• Knowledge of clinical trial protocols and regulations
• Knowledge of data analysis and statistical methods
• Knowledge of Good Clinical Practice (GCP)
• Knowledge of medical terminology
• Knowledge of computer software programs such as Microsoft Office
Job Experience
• Previous experience in clinical research or clinical trials
• Experience in project management
• Experience in data collection and analysis
Job Responsibilities
• Developing clinical trial protocols
• Recruiting and selecting study participants
• Collecting and analyzing data
• Preparing reports and presentations
• Ensuring that the clinical trial is conducted in accordance with the protocol and applicable regulations
• Maintaining accurate records of the clinical trial
• Monitoring the progress of the clinical trial