Quality Assurance Specialist, Regulatory
- Requisition #: 172635
- Department: Genitourinary Medical Oncology
- Location: Houston, TX
- Posted Date: 1/14/2025
The primary purpose of the Quality Assurance Specialist position is to collaborate with the Department of Genitourinary Medical Oncology research team and Principal Investigators in all aspects of protocol management to ensure protocol compliance with all regulatory agencies and Good Clinical Practice. Maintains knowledge of the research process in compliance with institutional policies, IRB, and federal regulations. Provides department in-services/education seminars to assist the Clinical Research Group (CRG) in maintaining current knowledge of clinical research requirements.
KEY FUNCTIONS:
QUALITY ASSURANCE
* Assesses human subject research for quality assurance and compliance with Good Clinical Practice (GCP) conducted by the Genitourinary Medical Oncology (GU) Department.
* In conjunction with the RDAB, coordinates development and implementation of research policies related to the institutional and departmental programs to ensure regulatory compliance with federal, state and local laws.
* Responsible for the implementation of the audit program for the GU department. Includes review of audit tools, audit processes and orienting/training the GU Clinical Research Group (CRG). In consultation with the management team, develops data driven reports for Quality Assurance (QA) and training.
* Performs departmental routine and targeted audits of GU research trials for compliance with Standard Operating Procedures (SOPs), GCP, institutional policy and the code of federal regulations (CFR). The trials chosen for audit will primarily be investigator initiated trials (IIT's), but may also be sponsored trials or others being monitored by internal and/or external agencies. Generates audit reports and participates until resolution.
* Performs routine and targeted audits of CRG staff members as part of standard orientation. Generates an audit report and participates until resolution.
* Presents audit or monitoring findings to investigator and the clinical research team. Makes recommendations and ensures follow up. Tracks audits over time and reports trends to faculty and supervisors. Suggests or develops improvement tools based on findings.
* Routinely audits consent forms for consistency with protocol procedures and risks.
* Develops departmental process and tracking metrics in conjunction with the CRG managers and supervisors.
EDUCATIONAL ACTIVITIES
* Provides professional and ancillary staff education on relevant clinical research topics as requested.
* Assists physician facilitator with conducting the weekly research meeting including arranging speakers.
* Keeps current concerning oncology and data management issues through reading and/or attending meetings/in-services.
* Attends appropriate departmental meetings and institutional continuing education programs.
* Participates in various institutional committees and updates research staff on policy/procedure/informational updates
MARGINAL FUNCTIONS
* Demonstrates excellent oral and written communication skills when contacting other institutions, patients and agencies (i.e. NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, email, and/or face to face interactions. Assimilates pertinent information in order to compose written correspondence.
Other duties as assigned.
Working Conditions
Physical Demands
Indicate the time required to do each of the following physical demands:
EDUCATION:
Required: Bachelor's degree in Healthcare, Nursing or a related healthcare field.
EXPERIENCE:
Required: Three years of professional experience in a healthcare or academic setting with one year experience with research protocols, regulatory compliance or education. May substitute required education with additional years of equivalent experience or applicable degree on a one to one basis.
Preferred: Expertise in clinical research compliance and monitoring, strong organizational and communication skills, and experience managing regulatory submissions and documentation to ensure timely, accurate study support.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
#LI-Hybrid
KEY FUNCTIONS:
QUALITY ASSURANCE
* Assesses human subject research for quality assurance and compliance with Good Clinical Practice (GCP) conducted by the Genitourinary Medical Oncology (GU) Department.
* In conjunction with the RDAB, coordinates development and implementation of research policies related to the institutional and departmental programs to ensure regulatory compliance with federal, state and local laws.
* Responsible for the implementation of the audit program for the GU department. Includes review of audit tools, audit processes and orienting/training the GU Clinical Research Group (CRG). In consultation with the management team, develops data driven reports for Quality Assurance (QA) and training.
* Performs departmental routine and targeted audits of GU research trials for compliance with Standard Operating Procedures (SOPs), GCP, institutional policy and the code of federal regulations (CFR). The trials chosen for audit will primarily be investigator initiated trials (IIT's), but may also be sponsored trials or others being monitored by internal and/or external agencies. Generates audit reports and participates until resolution.
* Performs routine and targeted audits of CRG staff members as part of standard orientation. Generates an audit report and participates until resolution.
* Presents audit or monitoring findings to investigator and the clinical research team. Makes recommendations and ensures follow up. Tracks audits over time and reports trends to faculty and supervisors. Suggests or develops improvement tools based on findings.
* Routinely audits consent forms for consistency with protocol procedures and risks.
* Develops departmental process and tracking metrics in conjunction with the CRG managers and supervisors.
EDUCATIONAL ACTIVITIES
* Provides professional and ancillary staff education on relevant clinical research topics as requested.
* Assists physician facilitator with conducting the weekly research meeting including arranging speakers.
* Keeps current concerning oncology and data management issues through reading and/or attending meetings/in-services.
* Attends appropriate departmental meetings and institutional continuing education programs.
* Participates in various institutional committees and updates research staff on policy/procedure/informational updates
MARGINAL FUNCTIONS
* Demonstrates excellent oral and written communication skills when contacting other institutions, patients and agencies (i.e. NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, email, and/or face to face interactions. Assimilates pertinent information in order to compose written correspondence.
Other duties as assigned.
Working Conditions
| This position requires: | | | |
| | Working in Office Environment | ______ No | __X____ Yes |
| | Working in Patient Care Unit (e.g. Nursing unit; outpatient clinic) | X______ No | ______ Yes |
| | Exposure to human/animal blood, body fluids, or tissues | __X____ No | ______ Yes |
| | Exposure to harmful chemicals | __X____ No | ______ Yes |
| | Exposure to radiation | __X____ No | ______ Yes |
| | Exposure to animals | ___X___ No | ______ Yes |
Physical Demands
Indicate the time required to do each of the following physical demands:
| | Time Spent | ||||
| Never 0% | Occasionally 1-33% | Frequently 34-66% | Continuously 67-100% | ||
| Standing | | | X | | |
| Walking | | | X | | |
| Sitting | | | | X | |
| Reaching | | | X | | |
| Lifting/Carrying | |||||
| | Up to 10 lbs | | | X | |
| | 10lbs to 50 lbs | | X | | |
| | More than 50 lbs | X | | | |
| Pushing/Pulling | |||||
| | Up to 10 lbs | | | X | |
| | 10lbs to 50 lbs | | X | | |
| | More than 50 lbs | X | | | |
| Use computer/keyboard | | | | X | |
EDUCATION:
Required: Bachelor's degree in Healthcare, Nursing or a related healthcare field.
EXPERIENCE:
Required: Three years of professional experience in a healthcare or academic setting with one year experience with research protocols, regulatory compliance or education. May substitute required education with additional years of equivalent experience or applicable degree on a one to one basis.
Preferred: Expertise in clinical research compliance and monitoring, strong organizational and communication skills, and experience managing regulatory submissions and documentation to ensure timely, accurate study support.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
- Requisition ID: 172635
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Days
- Minimum Salary: US Dollar (USD) 75,000
- Midpoint Salary: US Dollar (USD) 93,500
- Maximum Salary : US Dollar (USD) 112,000
- FLSA: exempt and not eligible for overtime pay
- Fund Type: Soft
- Work Location: Hybrid Onsite/Remote
- Pivotal Position: Yes
- Referral Bonus Available?: Yes
- Relocation Assistance Available?: Yes
- Science Jobs: Yes
#LI-Hybrid
