Manager, Clinical Research - Hematology Maliginacy - Cancer Researh - Simmons Cancer Center
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POST DATE 2/14/2020
END DATE 3/10/2020
UT Southwestern Medical Center
JOB DESCRIPTIONEXPERIENCE 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.
Managing overall DOT research functions, which includes working closely with DOT leaders to manage pipeline of studies, organizing monthly DOT meetings and assisting in the development of investigator initiated trials.
Managing coordinating staff which includes hiring, initial training and onboarding, continuing education and development as well as performance management.
Maintains ability to function as a study coordinator when required. 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.
General study management activities which includes monitoring accrual, facilitating continuing review, maintain relationships with sponsor, pharmacy, ancillary and clinic staff.
Playing an 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.
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. 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 UT SOUTHWESTERN POLICY TO PROHIBIT DISCRIMINATION ON THE BASIS OF SEXUAL ORIENTATION, GENDER IDENTITY, OR GENDER EXPRESSION..