Regulatory Affairs Associate - Clinical Research

Job Duties

• Covers regulatory correspondence across internal stakeholders and external institutions.
• Prepares protocol documents and required regulatory forms to obtain institutional and regulatory agency approval for 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 these regulations, guidelines, and SOPs.
• Develops and maintains positive relationships with institutional review committees and sponsors through oral and written communications.
• Acts as a liaison between institutional review committees, regulatory agencies, and investigators to ensure protocols obtain applicable approvals, amendments are submitted appropriately, and annual renewals are obtained.
• Facilitates investigators in consent form creation and protocol editing.
• Works closely with the study team, research staff, and investigators to ensure regulatory documents for research studies are up-to-date.
• Prepares for FDA meetings, inspections, and audits from regulatory authorities.
• Is available on-site during audit visits to respond to auditor inquiries.
• Facilitates communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.
• 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, assisting 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.
• 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.

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.
• 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.
• A 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.