MD Anderson Cancer Center Clinical Research Quality Specialist - IND Office in Houston, Texas
The primary purpose of the Clinical Research Quality Specialist position is to conduct education, evaluation and review of clinical trial conduct to ensure research and scientific integrity relating to human subject research and compliance with institutional policies, federal regulations, and Guidelines to Good Clinical Practice for clinical research trials where MD Anderson holds the IND.
Conducts training, evaluation and review of clinical trials, large-scale multi-protocol, multi-institutional, and cancer control projects to ensure research integrity and compliance with institutional policies and regulations.
Impacts the institution by ensuring compliance and scientific integrity with institutional and regulations relating to clinical research.
Monitor Protocol Compliance:
Assess the conduct and progress of assigned clinical trials by monitoring compliance with the protocol and clinical study schedule to ensure safety of human subjects and ensure compliance with all regulatory agency requirements and institutional policies relating to human subject research.
Protocol Review and Initiation:
Provides protocol review prior to initiation and advises principal investigators and research teams of necessary amendments and source documentation procurement. Represents the sponsor in protocol development, study initiation activities, and study termination activities.
Initiative and Education:
Initiates actions necessary with principal investigators and research teams to correct potential issues and steers special investigations to assess issues concerning scientific integrity. Creates reports documenting all relevant investigation conduct from ongoing site visits
Educates the physicians and other staff on management of the clinical trial, new regulations, Good Clinical Practice, policies and procedures, and current events relating to human subject research.
Position might require travel outside of Houston.
Required: Graduation from an accredited school of professional nursing.
Preferred: Bachelor of Science in Nursing.
Required: Five years of nursing experience to include at least two years of clinical research experience.
LICENSURE / CERTIFICATION
Current license to practice professional nursing in the State of Texas (RN).
Basic Life Support (BLS) or Cardiopulmonary Resuscitation (CPR) certification. American Heart Association Basic Life Support (BLS).
American Heart Association Basic Life Support (BLS), ACLS (Advanced Cardiac Life Support) or PALS (Pediatric Advanced Life Support) certification as required by patient care area.
Advanced Oncology Certified Nurse (AOCN), Oncology Certified Nurse (OCN), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), Certified Clinical Research Professional (CCRP), or Regulatory Affairs Certification (RAC).
Must pass pre-employment test as required and administered by Human Resources.
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
Requisition ID: 133383
Employment Status: Full-Time
Employee Status: Regular
FLSA: exempt and not eligible for overtime pay
Work Week: Days
Fund Type: Hard
Pivotal Position: Yes
Minimum Salary: US Dollar (USD) 79,600
Midpoint Salary: US Dollar (USD) 99,500
Maximum Salary : US Dollar (USD) 119,400
Science Jobs: Yes