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Research Quality Assurance Manager

"You can make a difference in the life of an oncology patient and find your career satisfaction by joining our team of healthcare professionals today."

About Oncology Consultants

Oncology Consultants has been a premier adult medical oncology & hematology practice in Houston, TX for over 25 years. Our healthcare team is committed to provide state of the art cancer treatment in a caring environment as we continue to expand our oncology services in the metropolitan region.. 

 

Shift Schedule:

  • Mon - Fri: 8am - 5pm

Benefits:

  • Insurances: Life, medical, dental, short term and long term disability
  • 401K
  • Free parking
  • PTO
  • Holidays 
  • Competitive salary

About the Position

Research Quality Assurance manager will work under direction of the Director of the Clinical Research Resources Offices (CRRO) as the lead auditor. They will assist in developing/refining process to identify research studies to select for QA reviews, which are brief quality assurance "checks" at early stage of the conduct of the research with the goal to help investigators and study staff perform their research in compliance with applicable regulations, policies and guidance to ensure safety of research participants and reliability/validity of study data.

This individual will  assigned reviews to staff as well as conduct reviews and complete written reports to the Principle Investigator identifying areas of non-compliance and providing advise on implementation of best practices to assure ethical conduct of research. They will also conduct for-cause audits and assign other QA staff to audits as needed. Along with other staff members the RQAM will advise investigators on reporting of findings to the IRB as well as advise on the development of Corrective and Preventative Actions plans (CAPA) as necessary. As a function of the QA role this individual will provide assistance to clinical researches concentrating on issues that come up in QA reviews. He / She will work with the Research Department Director and Administrator in identifying and developing educational priorities also, assist in investigators consultations including questions on study implementation. preparation for FDA inspections, assistance with FDA IND/IDE requirements, informed consent process and issues. Hippa issues DSMP development etc.,

QUALIFICATIONS:

  • Bachelors with a 5 years experience
  • Detail-oriented and have ability to multi task
  • Experience in auditing
  • Experience in Clinical Research and advance knowledge of regulations/guidance guiding human research including HHS/OHRP, FDA, ICH, GCP etc.
  • Strong verbal and written communication skills
  • Excellent interpersonal skills required
  • Strong computer skills, including experience with databases, spreadsheets
  • Knowledge of HIPPA regulations for research
  • Experience submitting IRB applications and managing IRB submission efforts
  •  

This description is intended to describe the essential job functions, the general supplement functions and the essential requirements for the performance of this job. It is not an exhaustive list of all duties, responsibilities of a  person so classified. Other functions may be assigned and management retains the right to add or change the duties at any time.

 

Oncology Consultants is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.

Medical Center | Memorial City | Sugar Land | Katy | Willowbrook | Southwest Northwest | West Houston

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