The Research Administration 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.Job Duties
- Coordinate regulatory correspondence across internal stakeholders and external institutions. Prepare 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.
- Maintain and expand understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs.
- Maintain working knowledge of regulatory requirements through independent continuing education using guidelines, articles, and courses.
- Develop and maintain positive relationships with institutional review committees and sponsor through oral and written communications.
- Act 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.
- Provide input to the investigators in consent form creation and protocol editing.
- Work closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
- Prepare for FDA meetings, inspections, and audits from regulatory authorities. Is available on site during audit visit to reply to auditor inquiries.
- Handle aspects of more complex regulatory assignments including multi-site studies and Investigator held INDs
- Assure distribution of appropriate information between investigators, regulatory agencies and staff involved in implementation of research projects
- Participate in feasibility, implementation, and site initiation meetings, teleconferences, monitor visits, research audits and other onsite meetings as required.
- Assist with training of entry level employees as assigned.
- Practice a high level of integrity and honesty in maintaining confidentiality.
- Participate as an active member of the protocol team as follows:
- Work proactively and collaboratively with other team members to streamline work and achieve mutual goals.
- Plan and pursue activities to promote self development related to hematology/oncology and regulatory issues. Look for opportunities to improve performance; manages time, work, and relationships effectively and efficiently.
- Required: Bachelor's degree.
- Required: 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. Experience to include:
- Demonstrated knowledge of regulatory processes and applicable regulations.
- Ability to manage regulatory aspects of multiple research projects.
- Certification in Clinical Research, SOCRA or other preferred.
- 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 manage shifting priorities in short time frames.
- Should have excellent oral and written communication skills
- Knowledge of medical/scientific terminology preferred
- Excellent organization skills; ability to multi-task
- Strong computer skills including Microsoft Office Suite
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
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