ID: 7057827 (Ref.No. 303445KP)
Posted: June 14, 2019
Application Deadline: Open Until Filled
Regulatory affairs coordinator works to support the Protocol Office and investigators associated with The Texas Children’s Cancer and Hematology Centers (TXCH) and Vannie Cook Children’s Clinic (VCCC). This support includes, but is not limited to, assisting in creating protocol documents, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees and ensuring successful navigation of approval processes for clinical research. The reg coordinator is able to work autonomously and is assigned to the more complex protocols of the Protocol Office.
- Prepares protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of the more complex clinical research projects (e.g., multiple regulatory agencies, multi-site protocols, gene therapy research) at the TXCH and VCCC.
- Demonstrates understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs.
- Assists investigators with creating protocol documents and consent forms.
- Develops and maintains positive relationships with regulatory agencies, sponsors and other sites 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.
- For multi-site protocols, maintains a positive relationship with the site through written and oral communication distributes protocol related documents and coordinates collection of applicable regulatory documents from the sites.
- Reports and responds to institutional review committees’ and other regulatory agencies’ inquiries or comments.
- Assists with and prepares for FDA meetings, inspections, and audits from regulatory agencies.
- Maintains working knowledge of regulatory changes through guidelines, articles, and courses.
- 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
- Assists with regulatory affairs training as needed and requested.
- Provides recommendations for process improvements.
- Participates as an active member of the protocol team as follows: Attends all required meetings and conferences, contributes pertinent protocol information and uses information presented to learn about hematology/oncology, 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.
Required: Bachelor's degree in an applicable field or equivalent applicable work. Preferred: Master's degree and/or additional course work
No experience is required. Preferred: Regulatory Affairs Certification