Manager, Clinical Research - Cancer Center

Summary

The CRO Manager, Clinical Research (CRM) is responsible for the direct management, organization, training, and career development of the clinical research staff throughout the Texas Children's Cancer and Hematology Centers (TXCH) enterprise. The CRM leads cross-functional teams and works with division leaders to identify/mitigate/escalate project issues including clinical research database development and ensures solutions are implemented. Moreover, the CRM is accountable for ensuring that all project deliverables meet division expectations and timelines.

Job Duties

• Implements standard operating procedures (SOPs), ensures quality control, and maintains site certifications.
• Ensures institutional and federal compliance.
• Manages financial aspects of clinical trials, including developing and negotiating budgets and pre and post award financial management.
• Schedules, coordinates, and participates in the internal feasibility meeting, pre-site visit and site initiation visits.
• Supports investigators and clinical research staff with reporting, study monitoring, and site visits.
• Develops, implements, and monitors research protocols, procedures, and processes.
• Oversees data collection and documentation activities; queries databases and prepares reports; manages compliance documents.
• Supervises clinical research and administrative staff; provides training and guidance on regulations and best practices.
• Prepares research presentations and draft manuscripts.

Minimum Qualifications

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

Preferred Qualifications

• Direct experience in clinical research is a must
• A good understanding of project management techniques
• Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations
• Good proficiency in Microsoft Word, Excel, and PowerPoint, Outlook and Internet Explorer
• Effective verbal and writing skills; prior experience with oral presentation

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.

13835

CA; SN