Clinical Operations Supervisor

Job Overview:

Great opportunity for a Clinical Research professional to gain leadership skills in a Supervisor role. This position is office based in our Dallas Clinic. 

Responsible for ensuring that all practical aspects of clinical studies are conducted to the highest possible quality and in accordance with the protocol, SOPs and ICH/GCP standards. Provides leadership, training, coaching and mentoring for study staff.

Duties and Responsibilities:
• Directly supervises and provides performance related feedback to Research Technicians and coordinators.

• Directly reports to the Clinical Operations Manager.

• Coaches and mentors staff. Initiates, plans and implements appropriate staff development programs.

• Current knowledge of ICH/GCP standards.
• Ensure that the safety, welfare and dignity of research subjects are conducted as per SOPs and ICH/GCP guidelines.
• Ensure the quality of data and service provided by team members meets the requirements of both internal and external clients.
• Deadline driven and detail oriented in order to provide clients with quality data and study conduction. 
• Play an active role in the development and implementation of Quality within his/her area of responsibility.
• Ensure that appropriate training programs are in place so that all personnel under his/her supervision are adequately and properly trained for their job requirements.
• Ensure that all training files are up to date and complete in accordance with SOPs and ICH/GCP.
• Ensure all work in his/her area is carried out in strict accordance with relevant protocols, SOPs, and in compliance with ICH/GCP.
• Assist with planning of study set up, as needed.
• Ensure that the staff under his/her supervision area at all times adequate in quality and quantity to meet the agreed forecasted workload.

• Ensure that full and accurate data records are maintained.
• Keep management up to date on all aspects of his/her job and initiate improvements.
• Respond constructively to management and QA ensuring that any GCP/ICH deficiencies are followed up with prompt remedial action.
• Performs supervisory duties including but not limited to interviewing, hiring, training, intervention, discipline, and discharge of operations staff.
• Ensures that up to date manuals of SOPs and Policy and Procedures are available to all personnel in his/her work area.
• Schedules investigators for protocol-related tasks.
• Schedules staff as appropriate for clinic requirements.
• Complies with departmental meeting schedules.
• Assists, as necessary, with study procedures.
• Tracks and evaluates Interdepartmental Monthly Key Result Indicators.

• Other duties as assigned.

Education/Qualifications:

Education:

• BS in science or medical field or LPN, LVN or AD degree
• Six Sigma Green Belt is preferred.

Experience:

Minimum Work Experience:

• 3 years related experience including 1-2 years of clinical research (preferably Phase I) experience with a BS degree.
• 5-7 years of related experience including 1-2 years of clinical research (preferably Phase I) experience with a RN, LPN, LVN or AD degree
• Additional experience may be substituted for education

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