Study Designer

Altasciences•Overland Park, KS

About The Position

The Study Designer is responsible for the design/creation and maintenance of source used to capture data during clinical trials either on a paper format or within an Electronic Data Capture (EDC) system. The Study Designer will conduct What You'll Do Here within compliance of study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures.

Requirements

High School Diploma completed; college degree and related work experience preferred.
Strong Communication skills
Detail oriented, well organized, customer service focused, able to work in fast-paced environment.

Responsibilities

Ensure the confidentiality of clinical trial volunteers and sponsors is respected.
Maintain and advocate a high level of quality and customer service within the department.
Understand protocol driven timed study events and acceptable collection windows (protocol and/or SOP driven) for the timed events.
Review clinical trial protocols/manuals and SOPs to assess criteria that needs to be captured during clinical trial execution.
Maintain a continuous line of communication with clinical operations teams and data management teams on the progression of clinical study designs.
Perform internal reviews of clinical study designs.
Maintain a library of general template designs.
Provide clinical study designs to clinical operations teams for review/approval in a time efficient manner.
Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.
Complete and/or maintain training as required per jobs needs.
Attend and/or participate in meetings (i.e. protocol, study design).
Perform general administrative tasks when required.