Supv II ClinOps

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></p><p style="margin: 0px;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"> </span></p><ol><li style="margin-left: 0in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Duties and Responsibilities:</strong></span></li></ol><ul><li style="margin-left: .25in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Directly supervises staff which may consist of RNs, LVN/LPNs, and Research Technicians.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Current knowledge of ICH/GCP standards.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Demonstrate ability to lead by example and to encourage team members to seek solutions.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure that the safety, welfare and dignity of research subjects are not compromised.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure the quality of service provided by team members meets the requirements of both internal and external clients.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Play an active role in the development and implementation of Quality within his/her area of responsibility.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Assist with the coordination of relevant protocols.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure that all training files are up to date and complete in accordance with SOPs and ICH/GCP.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure all work in his/her area is carried out in strict accordance with relevant protocols, SOPs, and in compliance with ICH/GCP.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensures that the CRF product meets the customer expectations.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Assist with planning of study set up, as needed.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure that a safe working environment is maintained and that safe working practices are employed.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure that full and accurate data records are maintained.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Keep management up to date on all aspects of his/her job and initiate improvements.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Manage his/her area so as to meet the budgeted standard of performance.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Respond constructively to management and QA ensuring that any GCP/ICH deficiencies are followed up with prompt remedial action.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Performs supervisory duties including but not limited to interviewing, hiring, training, intervention, discipline, and discharge of operations staff.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Coaches and mentors staff. Initiates, plans and implements appropriate staff development programs.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensures that up to date manuals of SOPs and Policy and Procedures are available to all personnel in his/her work area.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Schedules investigators for protocol-related tasks.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Updates or creates SOPs/P&Ps germane to their area of expertise.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Schedules staff as appropriate for clinic requirements.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Complies with departmental meeting schedules.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Assists, as necessary, with study procedures.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Tracks and evaluates Interdepartmental Monthly Key Result Indicators.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Continuously seeks out new and better ideas, driving best practices.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">BS in science or medical field or LPN, LVN or AD degree</span></li></ul><h2>Experience:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">3 years related experience including 1-2 years of research experience with a BS degree.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">5-7 years of related experience including 1-2 years of research experience with a LPN, LVN or AD degree</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Additional experience may be substituted for education.</span></li></ul>