Director I - Research Operations & Planning

Office of Medical Research

The University of Missouri School of Medicine is seeking a dynamic and experienced leader for the position of Director of Clinical Research Operations. This leadership role will oversee and direct the daily operations of clinical research staff within two Clinical & Translational Units (CTSU), ensuring the safe, efficient, and high-quality conduct of clinical research across these two locations.
With a team of approximately 14 clinical research professionals, including RNs, coordinators, laboratory professionals, administrative professionals and students, the Director will be responsible for managing and overseeing over 700 clinical research visits annually, along with 300+ clinical research/trial enrollments in FY23 and an anticipated 500 enrollments in FY24. The CTSU conducts clinical research and trials that have the potential for enrollment and research activity outside of business hours. The CTSU is engaged in 53 clinical research studies and trials, collaborating with numerous departments across the School of Medicine and University of Missouri System.
This is a pivotal role in driving the success of clinical research/trial activity, growth, ensuring safety, regulatory compliance, and alignment with best practices to support groundbreaking research across a wide array of clinical studies and trials.

Key Responsibilities:

* Plan, direct, coordinate and/or delegate/assign all CTSU clinical research/trial activities. Assign clinical trials to the appropriate location and to the correct CTSU staff based on participant safety, study complexity and details. Direct, oversee, supervise, and assign duties and responsibilities to clinical research nurses (5), PRN clinical research nurses (3-5), clinical research coordinators (3-4), clinical research lab tech (1-2), office support staff (2), clinical research students (2-5).
* Assist in developing, preparing, assigning and reviewing clinical trial budgets for projects that will utilize CTSU services and staff.
* Collect, analyze and report department metrics to organizational leaders up to and including the Senior Director of Clinical Research Ops, Vice Chancellor of Health Affairs, Dean of Research, and other clinical trials research leaders. Engage in setting department goals and performance targets, develop and implement process improvement strategies and monitor results.
* Receive and review study intake forms for incoming research trials/studies from industry sponsors and investigators. Consult, advise and meet with investigators conducting clinical trials and assist with development of study budgets, feasibility assessments, study complexity scores, coordinator and nursing assignments, team communication plans and regulatory compliance issues associated with clinical trial protocols.
Ensure compliance with FDA, IRB and ICH/GCP rules, regulations and guidelines. Ensure safety,
welfare, and privacy of clinical trial participants.
* Ensure CTSU clinical trials are monitored for quality and adherence to regulations. Oversee study activities and documentation including informed consents, regulatory documents, approval letters and adverse-event reporting.
* Recruit, hire, onboard/train, retain and evaluate staff. Monitor staffing levels and design and recommend methods for staff retention, additional staff recruitment, staff schedules, in order to meet the business needs of the unit(s). Provide oversight to staff deployed across two units in two separate locations and/or deployed to University of Missouri Hospitals and Clinics. The hours of availability across the units require 24/7 oversight by the incumbent.
* Collaborate with MU Healthcare hospital and clinic staff to ensure continued support of clinical trials by hospital services such as IV team, Rapid Response team, clinical engineering, and inpatient and clinic staff to ensure access and support for clinical trials research as appropriate.
* Identify and obtain appropriate staff nurse and study coordinator training to ensure staff are safe to perform novel clinical trial procedures, coordinators are up to date on regulatory requirements.
* Build strong professional relationships with department investigators and department research staff to ensure a collaborative and team environment and atmosphere in CTSU and with CTSU staff.

Shift Type: Monday through Friday 8am - 5pm, with 24/7 coverage oversight.
Flexibility for Alternative Schedules: No

A Master's degree or an equivalent combination of education and relevant experience and at least 5 years of experience from which comparable knowledge and skills can be acquired is necessary.

Clinical research trial experience, leadership experience, medical knowledge. Preferred certification in clinical research by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA)

Hiring Range: $78,562 - $130,000
Grade: GGS-013
University Title:DIRECTOR I RESEARCH OPERATIONS AND PLANNING
Internal applicants can determine their university title by accessing the Talent Profile tile in myHR.

In addition to completing the online application please provide a Resume.

Columbia offers small-town friendliness with big city features and a high quality of life for people of all ages and interests. Founded on education and known as an ideal college town, its location also makes it an attractive spot for businesses and travelers. Located on Interstate 70 and U.S. Highway 63, Columbia is right in the middle of the state and the nation. Just a couple hours' drive from St. Louis and Kansas City, Columbia is Boone County's largest population center offering big-city culture, activities, and resources with a low cost of living. Columbia is home to a variety of restaurants and entertainment venues and hosts more than a dozen cultural festivals each year. If you want to grow your career, continue your education, raise a family, and retire, Columbia is a good place to be!

This position is eligible for University benefits. As part of your total compensation, the University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, paid time off, short- and long-term disability, paid parental leave, paid caregiver leave, and educational fee discounts for all four UM System campuses. For additional information on University benefits, please visit the Faculty & Staff Benefits website at https://www.umsystem.edu/totalrewards/benefits.

Values Commitment

We value the uniqueness of every individual and strive to ensure each person's success. Contributions from individuals with diverse backgrounds, experiences and perspectives promote intellectual pluralism and enable us to achieve the excellence that we seek in learning, research and engagement. This commitment makes our university a better place to work, learn and innovate.

In your application materials, please discuss your experiences and expertise that support these values and enrich our missions of teaching, research, and engagement.

Equal Employment Opportunity

The University of Missouri System is an Equal Opportunity Employer. Equal Opportunity is and shall be provided for all employees and applicants for employment on the basis of their demonstrated ability and competence without unlawful discrimination on the basis of their race, color, national origin, ancestry, religion, sex, pregnancy, sexual orientation, gender identity, gender expression, age, disability, or protected veteran status, or any other status protected by applicable state or federal law. This policy applies to all employment decisions including, but not limited to, recruiting, hiring, training, promotions, pay practices, benefits, disciplinary actions and terminations. For more information, visit https://www.umsystem.edu/ums/hr/eeo or call the Director of Employee and Labor Relations at 573-882-2146.

To request ADA accommodations, please call the Director of Accessibility and ADA at 573-884-7278.