Posted 100 days ago in Biotech/Pharmaceutical
The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.
Experience:
Strong computer and internet skills including knowledge of MS Office products such as Excel, Word
Strong regulatory knowledge including GCP
Excellent interpersonal, verbal and written communication skills
Sound problem solving skills
Looks for win-win solutions to solve problems
Gives others appropriate latitude to make decisions
Carefully weighs the priority of project tasks and directs team accordingly
Understands the strengths and development areas of team members
Enlists the support of team members in meetings goals
Ability to successfully work in a team environment
Ability to lead a virtual, global team as required
Sound presentation skills
Consultative skills
Ability to make appropriate decisions in ambiguous situations
Ability to solve problems by using a logical, systematic, sequential approach
Client focused approach to work with the ability to interact professionally within a client organization
Ability to prioritize multiple tasks and achieve project timelines
Effective time management in order to meet daily metrics or team objectives
Shows commitment to and performs consistently high quality work
Able to take initiative and work independently
Sense of urgency in completing assigned tasks
Able to travel up to 65% on average
Education
Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience