Manager, Clinical Research, Simmons Comprehensive Cancer Center

Why UT Southwestern?

With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. As the only National Cancer Institute-designated comprehensive cancer center in North Texas, we invite you to continue your healthcare career with us at Harold C. Simmons Comprehensive Cancer Center. You’ll discover a magnet facility with a culture of teamwork, professionalism, and consistent opportunities for learning and advancement into leadership roles.

Job Summary

The Clinical Research Manager is responsible for the overall Phase I Disease Oriented Team (DOT), Solid Tumor, research functions and includes working closely with DOT leaders to manage pipeline of studies, organizing monthly DOT meetings and assisting in the development of investigator-initiated trials. Additionally, manages coordination of staff, which includes hiring, initial training and onboarding, continuing education and development as well as performance management. This role also provides oversight of study start up activities, which includes managing the progress of new trials through regulatory approval, contract and budgeting as well as ancillary reviews. Additional responsibilities include general study management activities such as monitoring accrual, facilitating continuing review, maintain relationships with sponsor, pharmacy, ancillary and clinic staff and playing an active role in quality assurance by participating in internal audits and implementation of corrective actions as required. This role also requires the incumbent to maintain ability to function as a study coordinator when required.

Experience and Education

Minimum Requirements

• Bachelors degree in science, social science, business, or health-related (including nursing) field and six (6) years related experience to include management experience, or.
• Masters degree in science, social science, business, or health-related (including nursing) field and four (4) years related experience to include management experience, or
• PhD or equivalent in science, social science, business, or health-related (including nursing) field and three (3) years related experience to include management experience.
• A Heart Saver for non-licensure or BLS for Licensure may be required based on research study protocols or affiliate location requirements.
• Prior experience in the UTSW clinical research mentoring program is highly desirable, and participation in the UTSW clinical research mentoring program may count as additional experience. 

Job Duties

• Reviews proposed new research studies and determines projects to implement; negotiates budget and contract issues; initiates regulatory activities; oversees preparation of necessary project summaries, consent forms, etc. for IRB; oversees compliance with all regulatory requirements.
• Oversees on-going research studies and quality assurance measures, developing criteria where necessary; negotiates favorable agreements with laboratories and collaborators on campus; monitors profitability of research studies; renegotiates contracts, supplements, etc. as needed.
• Directs financial oversight and management of clinical research unit; ensures invoicing is accurate and sponsor payments are received; ensures appropriateness of expenditures from various funding sources available to clinical research unit. Participates in selection process of clinical research unit staff; provides training to research, financial, laboratory, and administrative staff; evaluates staff performance and implements measures necessary to maintain quality performance and results; participates in training, development, and/or disciplinary measures; assesses policies and procedures to ensure optimal operation of clinical research unit.
• Identifies potential sponsors for clinical research unit; develops and oversees marketing strategies. Initiates and maintains collaborative relationships between clinical research unit and basic science facilities. 
• Designs, executes, and maintains effective system of internal controls which provides reasonable assurance that operations are effective and efficient, assets are safeguarded, and financial information is reliable.
• Ensures compliance with applicable laws, regulations, policies, and procedures. Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
• Performs other duties as assigned.

To learn more about the benefits UT Southwestern offers visit https://www.utsouthwestern.edu/employees/hr-resources/

For general COVID-19 information, applicants should visit https://www.utsouthwestern.edu/covid-19/work-on-campus/

This position is security-sensitive and subject to Texas Education Code §51.215, which authorizes UT Southwestern to obtain criminal history record information. UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.