Senior Research Administration Associate - Pediatrics - Hematology & Oncology Clinical Resear

Baylor College of Medicine

Houston, TX

Job posting number: #7062208 (Ref:2177-en_US)

Posted: November 6, 2019

Application Deadline: Open Until Filled

Job Description

Job Purpose

The Senior Research Administration Associate (SRAA) will provide training and quality control (QC) evaluations for staff of the Texas Children's Cancer Center and Hematology Service (TCCC/HS), the Center for Cell and Gene Therapy (CAGT). The SRAA also coordinates review, approval and associated training on Protocol Office Standard Operating Procedures (SOPs). The primary purpose of the training, the SOPs and the QC program is to ensure patient safety, verify accurate data collection, identify problem areas, and work with appropriate individuals to implement corrective action as necessary for all clinical research activities at TXCH/CAGT. The training program includes general training in clinical research, job specific training, and team/disease-specific training (which should be determined and developed in collaboration with the team leaders). The SRAA evaluations include evaluation of specific patient/protocol data to determine accuracy as well as evaluating compliance of the Clinical Research Operations staff to the relevant TXCH/CAGT Clinical Research SOPs. Results of the QC evaluations are reported back to the Clinical Research Oversight Committee (CROC) and to the team leaders (as appropriate).

Job Duties
  • Serve as a mentor and facilitator for the DM/RN/RC staff within TXCH/CAGT.
  • As new initiatives are implemented within the DM/RN/RC group, the SRAA will serve as the point person for the initiative.
  • Serve as the liaison between the DM/RN/RC staff and the team/group implementing change.
  • Support for clinical research operations by assisting in the preparation for audits by entities such as the FDA or by cooperative groups. Workflow is completed on a self-assigned, independent basis with responsibility to follow through to completion and meet deadlines as required.
  • Conduct review of Clinical Research Operations including review of data collection and compliance with SOPs
  • Consult in areas of expertise
.
  • Serve as an educator for clinical staff and faculty on clinical research issues
  • Direct communication with the team leaders, the Clinical Research Oversight Committee, the Assistant Director of the Protocol Office, physicians, nurse practitioners, and other team members is necessary to keep abreast of all new clinical research operations related issues.
  • Routine decisions include QC of clinical research operations and training of Clinical Research personnel
Minimum Qualifications
  • Required: Bachelor's degree.
  • Required: Four years of relevant experience.
Preferred Qualifications
  • Master's Degree in a health related field
  • Previous experience in oncology or pediatric research
  • CCRC, CCRA, CCRP certification
  • Previous experience in QC or QA
Other
  • B.S. or B.A. in a health related field
  • Four or more years experience in clinical research operations
  • Knowledge of clinical research
  • Experience in data abstraction and collection
  • Ability to work effectively with others and demonstrate team work

 

 

 

 

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

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