What are the responsibilities and job description for the Supv II ClinOps position at Labcorp?
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 staff which may consist of RNs, LVN/LPNs, and Research Technicians.
- Current knowledge of ICH/GCP standards.
- 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.
- Ensures that the CRF product meets the customer expectations. - 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. Recommend changes if necessary and justify them in accordance with company policy.
- 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 so as to meet the budgeted standard of performance. - 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.
Educational Qualifications:
- BS in science or medical field or LPN, LVN or AD degree
Experience:
- 3 years related experience including 1-2 years of research experience with a BS degree.
- 5-7 years of related experience including 1-2 years of research experience with a LPN, LVN or AD degree - Additional experience may be substituted for education.
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