Loading...

Title:  Research Administration Associate - Regulatory Affairs

Division:  Pediatrics
Schedule:  Monday - Friday, 8:00 a.m. - 5:00 p.m.
Work Location:  Texas Medical Center, Houston, TX
Salary Range:  $55,779 - $72,514
FLSA Status:  Exempt
Requisition ID:  2029
Summary

Official Title: Research Administration Associate

The Research Administration Associate works to support the Protocol Office and investigators associated with The Texas Children's Cancer and Hematology Centers (TCCHC). This position supports all aspects of regulatory compliance for a specified portfolio of clinical trials. This support includes, but is not limited to, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees and ensuring successful navigation of approval processes for clinical research.

Job Duties
  • Coordinates regulatory correspondence. Prepares protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of clinical research projects at the TCCHC and CAGT.
  • Develops and maintains understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs.
  • Maintains working knowledge of regulatory requirements through independent continuing education using guidelines, articles, and courses.
  • Develops and maintains positive relationships with institutional review committees and sponsor through oral and written communications.
  • Acts as a liaison between institutional review committees, regulatory agencies and the investigators to ensure that protocols obtain applicable approvals, that protocol amendments are submitted appropriately and that annual renewals are obtained.
  • Assists the investigators in reporting and responding to institutional review committees' and other regulatory agencies' inquiries or comments.
  • Assists the investigators in consent form creation.
.
  • Facilitates communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.
  • Assures distribution of appropriate information between investigators, regulatory agencies and staff involved in implementation of research projects
  • Maintains regulatory database as applicable. Maintains electronic and paper study files in accordance with local SOPs, sponsor and general industry standards ensuring documentation is complete, up to date, and audit ready
  • Keep the study team and AD informed of protocol related issues.
  • Participates in teleconferences, on site meetings, monitor visits and research audits as required.
  • Practices a high level of integrity and honesty in maintaining confidentiality.
.

Participates as an active member of the protocol team as follows:

 

  • Works proactively and collaboratively with other team members to streamline work and achieve mutual goals.
  • Attends all required meetings and conferences, contributes pertinent protocol information and uses information presented to develop an understanding of the hematology/oncology landscape, in order to more accurately assist in the preparation of submissions.
  • Plans and pursues activities to promote self development related to hematology/oncology and regulatory issues. Looks for opportunities to improve performance; manages time, work, and relationships effectively and efficiently.
Minimum Qualifications
  • Required: Bachelor's degree.
  • Required: Two years of relevant experience.
Other

Skills:

  • Should have excellent oral and written communication skills
  • Knowledge of medical/scientific terminology preferred
  • Excellent organization skills;ability to multi-task
  • Strong computer skills including Microsoft Office Suite
  • High sense of professional behavior and conduct and an ability to communicate with various levels of faculty and staff within Baylor College of Medicine and outside organizations

Knowledge:

  • Knowledge of the federal regulations and ICH GCP guidelines preferred

 

 

 

 

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

 2029

CA; CH