Clinical Operations Supervisor II / Dallas, TX (On-Site)

Role Summary

Clinical Operations Supervisor II in Dallas, TX (On-Site). Leads and mentors study staff in a fast-paced, office/clinic-based clinical research environment, coordinating protocols and ensuring high-quality execution in line with ICH/GCP standards. Directly interacts with healthy volunteers and supports the multidisciplinary team in Phase 1 trials.

Responsibilities

• 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.
• Directly supervises staff which may consist of RNs, LVN/LPNs, and Research Technicians.
• Demonstrate ability to lead by example and to encourage team members to seek solutions. Ensure that the safety, welfare, and dignity of research subjects are not compromised.
• Ensure the quality of service provided by team members meets the requirements of both internal and external clients.
• Instill in all team members responsible to him/her the Company's commitment to quality and meeting the client's requirement without error, on time, every time.
• Play an active role in the development and implementation of Quality within his/her area of responsibility.
• Assist with the coordination of relevant protocols.
• 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.
• Ensure that the CRF product meets the customer expectations.
• Assist with planning of study set up, as needed.
• Always ensure that the staff under his/her supervision are adequate in quality and quantity to meet the agreed forecasted workload.
• Ensure that a safe working environment is maintained and that safe working practices are employed.
• Ensure that full and accurate data records are maintained.
• Keep management up to date on all aspects of his/her job and initiate improvements.
• Manage his/her area to meet the budgeted standard of performance.
• Recommend changes if necessary and justify them in accordance with company policy.
• 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.
• Coaches and mentors staff. Initiates, plans, and implements appropriate staff development programs.
• 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.
• Updates or creates SOPs/P&Ps germane to their area of expertise.
• 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.
• Works on a wide range of opportunities and problems where use of creative thinking and the application of related quality and continuous improvement theories and principles is required.
• Continuously seeks out new and better ideas, driving best practices.

Qualifications

• BS in science or medical field or LPN, LVN or AD degree
• Six Sigma Green Belt is preferred
• Additional experience may be substituted for education
• Mandatory immunizations and screening as required
• Handling of biologically hazardous and radiolabeled material is necessary
• Must be able to see (distinguish colors) and hear to meet, if necessary, the job requirements
• Must have excellent command of the English language, both oral and written
• Must be able to use hands to finger, handle, or touch objects, tools, or controls, including a computer keyboard, for up to 6 hours per day
• Must be able to stand and/or bend for up to 6 hours per day
• Overtime and weekend work as required

Skills

• Leadership and staff development
• Quality management and compliance (ICH/GCP)
• Protocol coordination and study setup
• Data integrity and documentation
• Problem solving and process improvement

Education

• BS in science or medical field or LPN, LVN or AD degree

Additional Requirements

• Travel requirements not specified
• On-site availability in Dallas, TX