Job Description
Previous experience supervising a team within a CRO strongly preferred As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US. We are currently seeking Clinical Operations Supervisor I, to interact directly with our healthy volunteer participants while learning to read clinical research protocols and enjoy working in a fast-paced team-oriented environment. Each day is different, you will be exposed to a wide variety of Therapeutic Indications and study types (ascending dose, first-in-human, food effect, drug to drug interactions, etc.) This is a full-time, office/clinic-based job in Madison, WI If you join us, you will work with some of the worlds leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug. Many are drawn to this profession because of its direct impact on patient care. If this is your case, you will not miss that working in Phase 1 trials. Whilst allowing you to have a close face-to-face relationship with participants, and as you continue to practice your clinical skills and knowledge, youll be involved with the latest medical technologies and treatments, witnessing their development firsthand. When the drug you worked with gets approved, you know youll touch many patients lives around the world. WHAT YOU WILL DO: 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. Other key 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. nsures 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 area 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 mentor's 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 and 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