Manager - Quality Assurance - Clinical Research

University Of Texas Southwestern Medical Center   •  

Dallas, TX

Industry: Hospitals & Medical Centers

  •  

5 - 7 years

Posted 42 days ago

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.


Job Duties



Management of CRO quality assurance auditors and internal audit activity.


Ensures annual auditing goals are met according to the SCCC DSMC plan.


Provides input for annual review of DSMC plan as needed.Provides reports to Cancer Center oversight committees and CRO staff as to audit results and trends.


Participates in audit activities as needed to help support QACs including performance of internal audits in accordance with the SCCC-DSMC Plan.


Assists study teams in preparations for external audits


Participates as a PRMC member and reviewer, reviewing and critiquing the DSMP and data, registration portions of all newly submitted cancer related studies.


Works closely with the Associate Director CRO Operations to identify needs and help implement new initiatives related to monitoring, auditing, training and education (overall quality assurance) for the CRO and cancer clinical research at UTSW.

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.


Security


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

Salary


Salary Negotiable