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Regulatory Affairs Specialist - Clinical, Translational and Novel Therapy Research - Pediatrics - Allergy & Immunology (90002422)

Baylor College of Medicine

Houston, TX

Job posting number: #7092103 (Ref:9856-en_US)

Posted: January 11, 2022

Application Deadline: Open Until Filled

Job Description

Summary

Baylor College of Medicine, Department of Pediatrics, Immunology, Allergy and Retrovirology Division at Texas Children's Hospital is seeking a highly motivated, responsible, and organized individual to join as a Regulatory Affairs Specialist.

The Allergy and Immunology Division specializes in the diagnosis and treatment of complex Primary immune deficiency diseases (PIDD), which are rare, genetic disorders that impair the immune system. The service maintains vibrant clinical and basic scientific research program.  Including clinical trials for rare immune deficiency diseases. 

The selected candidate will supports all aspects of regulatory compliance for a specified portfolio of clinical trials and associated research protocols. 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 and translational research. This position requires an understanding of clinical research and applicable regulations.

Job Duties

  • Follows SOPs, coordinates regulatory correspondence across internal stakeholders and external institutions.
  • 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 TXCH.
  • Maintains and expands understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs.
  • 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.
  • At the guidance of the Principal Investigator and the Regulatory Affairs Supervisor, works closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
  • Enables communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.
  • Follows SOPs, ensures 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
  • Keeps the study team and supervisor informed of protocol related issues.
  • Practices a high level of integrity and honesty in maintaining confidentiality.
  • Works proactively and collaboratively with other team members to streamline work and achieve mutual goals.
  • Attends all required meetings, contributes pertinent protocol information and uses information presented to develop an understanding of the Allergy and Immunology 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.
  • Serves as a resource to clinical investigators and staff.
  • Manages shifting priorities in short time frames.

Minimum Qualifications

  • High School diploma or GED.
  • Four years of relevant experience.

Preferred Qualifications

  • Follows SOPs, coordinates regulatory correspondence across internal stakeholders and external institutions.
  • 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 TXCH.
  • Maintains and expands understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs.
  • Acts as a liaison between institutional re view 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.
  • At the guidance of the Principal Investigator and the Regulatory Affairs Supervisor, works closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
  • Enables communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.
  • Follows SOPs, ensures 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
  • Keeps the study team and supervisor informed of protocol related issues.
  • Practices a high level of integrity and honesty in maintaining confidentiality.
  • Works proactively and collaboratively with other team members to streamline work and achieve mutual goals.
  • Attends all required meetings, contributes pertinent protocol information and uses information presented to develop an understanding of the Allergy and Immunology landscape, in order to more accurately assist in the preparation of submissions.
  • Plans and pursues activities to promote self development related to immunological disorders and regulatory issues.
  • Serves as a resource to clinical investigators and staff.
  • Manages shifting priorities in short time frames.

 

 

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.

 9856

CA; SN 



Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care. - Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective. - Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve. - Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.


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More Info

Job posting number:#7092103 (Ref:9856-en_US)
Application Deadline:Open Until Filled
Employer Location:Baylor College of Medicine
Houston,Texas
United States
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