Study Support Specialist I

CareAbout•Overland Park, KS

About The Position

The Study Support Specialist will work with the Study Support teams to ensure the creation of study event designs and source. The Study Support Specialist will complete What You'll Do Here in compliance with study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOP)s.

Requirements

High School diploma or GED; college degree and related work
Excellent written and verbal communication (French and English at the Montreal location)
Leadership, interpersonal and organizational skills
Customer service focused, able to work in a fast-paced environment

Responsibilities

Ensure the confidentiality of clinical trial volunteers and sponsors is respected.
Maintain and advocate a high level of customer service and quality 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.
Create and/or revise the study event design for staff scheduling.
Ensure the review and approval of study event design, calendars and timelines are completed in a time efficient manner.
Maintain various study event calendars for the clinical operations teams.
Continuously update timeline workflows and programs.
May create graphical report for Investigator review.
Update and/or generate reports (i.e. flowsheets, meal logs).
Maintain a continuous line of communication with clinical operations teams on the progression of clinical trial study events, source designs and timelines.
Attend and/or participate in meetings (i.e. protocol, source design).
Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.