Clinical Trials Assistant

Job Description
The Clinical Trial Assistant is responsible for providing logistical support for one or more clinical trials‚ commensurate with complexity‚ throughout study start–up‚ conduct‚ and close–out. Job duties/responsibilities include:

Performs job duties with minimal guidance.
Communicates with sites regarding trial start–up‚ conduct‚ and close–out activities
Collects and reviews regulatory documents from clinical sites
Initiates‚ maintains‚ and reconciles Trial Master File
Organizes and maintains tracking systems and tools to support the conduct of a clinical study from start–up to close–out.
Maintains accurate tracking and reporting of study metrics
Coordinates communication of tracking information between Clinical Operations and vendors
Manages and tracks study specific payments
Manages and tracks clinical/non–clinical supplies
Generates and reviews management reports from internal tracking systems at requested intervals
Coordinates investigator meeting planning‚ including preparing meeting materials and on–site meeting implementation
Collaborates with Clinical Trial Manager on the development of certain study specific plans and/or processes
Provides support to CRAs and MDs in clinical protocol development
Travel may be required

Education

Bachelor’s degree and a minimum of 2 years experience in clinical research or healthcare related industry‚ or equivalent combination of education and experience

Skills

Knowledge of ICH/GCP
Training in Regulatory Compliance
Proficient computer skills across multiple applications
Effective written and verbal communication skills
Good judgment in triaging calls from study sites
Prioritizes and multitasks to ensure that tasks are completed on time
Effectively collaborates with team members