Manager, Clinical Research
The Clinical Research Organization (CRO) Clinical Research Manager (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.
- Manages the daily operations of a clinical trial and clinical research operations within the Pediatric Cancer & Hematology Centers
- Primary interface with TXCH staff members for clinical research projects
- Assesses clinical research staff effort and day-to-day work assignments
- Works with peers to coordinating and management of clinical research staff initiatives including CRA-led monthly medical provider education initiative and group meeting presentations
- Ensures completion of study specific training and timely deliverables from assigned clinical research staff
- Approves daily schedules, time-off requests and timesheets for assigned staff
- Leads annual performance appraisals for assigned clinical research staff
- Contributes to productivity metric development and reviews ongoing data
- Coordinates updates and training for clinical research databases including the TXCH research patient registry system
- Provides weekly cooperative group study updates and new patient information to teams
- Assists QA/QC with audit preparation organization
- Assists with onboarding activities for new faculty and clinical research staff
- Assists with CRO SOP development and updating
- Represents CRO on division-wide project teams as assigned
- Bachelor's degree.
- Four years of relevant experience. Degrees in lieu of experience will not be accepted.
- Bachelor degree in Health Administration or related field
- At least two years in a management capacity
- 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
- Research Nurse experience desirable
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.