The Regulatory Affairs Associate works to support the Protocol Office and investigators associated with The Texas Children's Cancer and Hematology Centers (TXCH). 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. This position requires an understanding of clinical research and applicable regulations. Reports to Director of Protocol and Regulatory Affairs.
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.
Works closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
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.
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 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.
Two years of relevant experience.
Four or more years of experience in regulatory affairs and/or clinical research at academic medical center or hospital with knowledge of clinical research practices and regulations.
Certification in Clinical Research, SOCRA.
Knowledge and understanding of clinical research compliance, including OHRP, FDA and other federal regulations and requirements regarding human subjects research, including but not limited to GCPs and related ICH guidelines, informed consent, adverse event reporting and monitoring, and other human subjects research protection requirements.
Ability to serve as a resource to clinical investigators and staff.
Ability to manage shifting priorities in short time frames.
Should have excellent oral and written communication skills.
Knowledge of medical/scientific terminology.
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 of clinical research and/or regulatory processes and the applicable federal regulations and ICH GCP guidelines.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
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.