Senior Supervisor, Clinical Research Operations

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 11.0pt;">Responsible for ensuring that the Clinical Operations aspect of all clinical studies (including coordination, planning and clinical conduct) 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 and less tenured Supervisors.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><strong><span style="font-size: 11.0pt;">Duties and Responsibilities:</span></strong></p><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Directly supervises and responsible for staff which may consist of RNs, LVN/LPNs, Research Technicians, Clinical Research Coordinators (CRCs) and Operational Coordinators (OCs)</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Current knowledge of ICH/GCP standards.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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: 11.0pt;">Ensure that the safety, welfare and dignity of research subjects are not compromised.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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: 11.0pt;">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: 11.0pt;">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: 11.0pt;">Assist with the assignment and coordination of protocols as required.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Assist with client visits and interactions as appropriate</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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: 11.0pt;">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: 11.0pt;">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: 11.0pt;">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: 11.0pt;">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: 11.0pt;">Ensure that good communications with both internal and external clients are maintained.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Ensure that full and accurate data records are maintained.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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: 11.0pt;">Manage his/her area so as to meet the budgeted standard of performance.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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: 11.0pt;">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: 11.0pt;">Coaches and mentors staff. Initiates, plans and implements appropriate staff development and training programs.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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: 11.0pt;">May perform CRC and OC duties/responsibilities in the absence of team OC or CRC.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Updates or creates SOPs/P&Ps germane to their area of expertise.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Schedules all staff as appropriate for study and clinic requirements.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Complies with departmental meeting schedules.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Assists, as necessary, with study procedures.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Tracks and evaluates Interdepartmental Monthly Key Result Indicators.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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: 11.0pt;">Continuously seeks out new and better ideas, driving best practices.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Performs other duties as assigned</span></li></ul><p style="margin: 0px;"><span style="font-size: 11.0pt;">***This position is office based in Dallas, TX***</span></p><h2>Education/Qualifications:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">BS in science or medical field</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">CCRC or CCRP</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Six Sigma Green Belt is preferred.</span></li></ul><h2>Experience:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">5 years research experience.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Minimum of 3-4 years supervisory experience or progressive and proven leadership responsibilities in clinical research coordination/management.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Additional experience may be substituted for education requirements.</span></li></ul><p style="margin: 0px;"><span style="font-size: 11.0pt;">#LI-ML1</span></p>