Supervisor, Clinical Operations

CareAbout•Overland Park, KS

About The Position

The Supervisor, Clinical Operations is responsible for the supervision and coordination of Clinical Operations team members and clinical activities during clinical trial execution. The Supervisor, Clinical Operations will ensure clinical activities are completed in compliance with study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOP)s. Schedule: Monday-Friday 1400-2300 and occasional weekends.

Requirements

High School diploma or GED and related job experience required; college degree preferred.
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

Management of the Clinical Operations team, including but not limited to, PTO management, timesheet approval, on-going and yearly performance reviews, employee hiring, disciplinary actions and termination.
Oversee, manage and/or coordinate the training and training records for the Clinical Operations team.
Proactively assess learning opportunities for the Clinical Operations team.
Provide direction to team members during the execution of clinical trial activities.
Ensure the confidentiality of clinical trial participants and sponsors is respected.
Maintain and advocate a high level of customer service and quality within the department.
Perform clinical trial activities, including but not limited to, data collection, safety measurements, sample handling and in-house testing.
Record adverse events and concomitant medication use and follow-up on on-going adverse events until resolution.
Provide a continuous line of communication with management teams on the progression of clinical trials.
May assist in sponsor visits and regulatory audits and ensure the timely resolution to any related findings.
May assist in the resolution of data queries.
May participate in SOP and protocol reviews.
Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.
Hold meetings with clinical members to communicate clinical trial needs and/or departmental objectives.