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

***Must possess at least 3-5 years of people management/direct reports experience.***

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 a Clinical Operations Supervisor II, 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 Dallas, TX.

If you join us, you will work with some of the world´s 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, you´ll be involved with the latest medical technologies and treatments, witnessing their development firsthand. When the drug you worked with gets approved, you know you´ll touch many patient´s 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 op