Senior Clinical Research Quality Control Associate

Location
Houston, Texas
Posted
November 20 2021
Ref
9413
Position Type
Full Time
Organization Type
Academia
Summary

The Senior Clincal Research Quality Control Associate will provide training and quality control (QC) evaluations for clinical research staff of the Texas Children's Cancer and Hematology Centers (TXCH) and the Baylor College of Medicine Center for Cell and Gene Therapy (CAGT). The Senior Clinical Research Quality Control Associate also coordinates review, approval, and associated training on Protocol Office Standard Operating Procedures (SOPs).

Job Duties

  • Ensures patient safety.
  • Verifies accurate data collection.
  • Identifies problem areas, and works with appropriate individuals to implement corrective action as necessary for all clinical research activities at TXCH/CAGT.
  • Trains in clinical research, job specific training, and team/disease-specific training (which should be determined and developed in collaboration with the team leaders).
  • Evaluates specific patient/protocol data to determine accuracy.
  • Evaluates compliance of the clinical research operations staff to the relevant TXCH/CAGT Clinical Research SOPs.
  • Reports results of the QC evaluations back to the Clinical Research Oversight Committee (CROC) and to the team leaders (as appropriate).
  • Serves as a mentor and facilitator for the DM/RN/RC staff within TXCH/CAGT.
  • Serves as point person for initiatives for DM/RN/RC staff.
  • Serves as the liaison between the DM/RN/RC staff and the team/group implementing change.
  • Provides support for clinical research operations by assisting in the preparation for audits by entities such as the FDA or by cooperative groups.
  • Works on a self-assigned, independent basis with responsibility to follow through to completion and meet deadlines as required.
  • Communicates with the team leaders, the Clinical Research Oversight Committee (CROC), the Director of the Protocol Office, medical records, physicians, nurse practitioners, and other team members is necessary to keep abreast of all new clinical research operations related issues.


Minimum Qualifications

  • Bachelor's degree.
  • Four years of relevant experience.


Preferred Qualifications

  • Master's Degree in health related field and CCRA, CCRP, or CCRC certification
  • At least 4 years experience in clinical research
  • Knowledge of clinical research operations, medical terminology, and anatomy; oncology knowledge and prior clinical research QA/QC experience


Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.