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Manager Clinical Research - Phase I - CRO - Simmons Cancer Center at UT Southwestern Medical Center

Posted in Other 30+ days ago.

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Type: Full Time
Location: Dallas, Texas

Job Description:

Full/Part Time/PRN: Day Job
Regular/Temporary: Regular
Schedule: Full-time


This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information

Experience and Education

Master's degree in science, social science, business, or health-related (including nursing) field and four (4) years related experience to include management experience.

Bachelor's degree in science, social science, business, or health-related (including nursing) field and six (6) years related experience to include management experience.

Years of relevant experience will beconsidered in lieu of education. Must have 10 years minimum of clinical research experience.

Job Duties

Support the Phase I program by:

* Works closely with the Phase I Operations Manager to manage day to day operations of the Phase I program including coordinating staff. Will take part in the hiring, initial training and onboarding, continuing education and development as well as performance management.

* Maintains ability to function as a Study Coordinator/Research Nurse when required.

* Assisting team in development of processes to manage screening queue.

* Takes part in management and operations within the Clinical Trials Unit, including development of CTU in new Cancer Center building.

* General study management activities which includes monitoring accrual, facilitating continuing review, maintain relationships with sponsor, pharmacy, ancillary and clinic staff.

* Playing active role in quality assurance by participating in internal audits and implementation of corrective actions as required.

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.

**Other Duties: Performs other duties as assigned.

UTSouthwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of: race; color; religion; national origin; sex; including sexual harassment; age; disability; genetic information; citizenship status; and protected veteran status. In addition, it is UTSouthwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.