The Regulatory Affairs Associate works to support the Protocol Office and investigators associated with Baylor College of Medicine Department of Pediatrics at 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 expertise and understanding of clinical research and applicable regulations.

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.

Job Duties

• 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.
• 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.
• Facilitates investigators in reporting and responding to institutional review committees' and other regulatory agencies' inquiries or comments.
• Provides input to the investigators in consent form creation and protocol editing.
• Works closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
• Prepares for FDA meetings, inspections, and audits from regulatory authorities. Is available on site during audit visit to reply to auditor inquiries.
• 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.
• Participates in feasibility, implementation, and site initiation meetings, teleconferences, monitor visits, research audits and other onsite meetings as required.
• 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 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.
• Performs other job related duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Two years of relevant experience.

Department Specific Criteria

• Two or more years of experience in regulatory affairs for clinical research at academic medical center or hospital with knowledge of clinical research practices and regulations.
• Demonstrated knowledge of regulatory processes and applicable regulations.
• Ability to manage regulatory aspects of multiple research projects.
• Ability to establish and maintain cooperative and mutually supportive working relationships with faculty, administrators, staff, other campus units, sponsors, their representatives, and other business partners.
• 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.

Preferred Qualifications

• Certification in Clinical Research, SOCRA or other preferred.
• 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 organization.