Manager, Clinical Research - Pediatrics - Newborn
Baylor College of Medicine
Summary
The Division of Neonatology (Newborn) in the Department of Pediatrics is seeking a Manager to support the division’s clinical research infrastructure. The Manager plays a critical role in the division’s success by overseeing daily research operations, resource allocation to support clinical trials and other research initiatives, research data governance, and regulatory compliance in partnership with Texas Children’s Hospital.
Job Duties
- Manages daily research operations, including cost and effort allocations for research staff, financial management, and invoicing for clinical trials and private awards.
- Ensures reports related to outcomes data are submitted, regularly reviewed, validated, and maintained.
- Manages and supervises research staff, including research coordinators, research associates, research assistants, staff scientists, and laboratory personnel; provides training and guidance on regulations and best practices.
- Oversees pre- and post-award activities and provides regulatory support for faculty members.
- Oversees the division's feasibility review process for potential clinical trials and research collaborations.
- Manages the daily operations of clinical trials and research studies.
- Develops and implements standard operating procedures (SOPs), ensures quality control, maintains site certifications, and ensures institutional and federal regulatory compliance.
- Manages the financial aspects of clinical trials, including budget development and negotiation, invoicing, and pre- and post-award financial management.
- Schedules, coordinates, and participates in internal feasibility meetings, pre-site visits, and site initiation visits.
- Supports investigators and clinical research staff with study reporting, monitoring activities, and site visits.
- Develops, implements, and monitors research protocols, procedures, and processes.
- Oversees data collection and documentation activities, queries databases, prepares reports, and manages compliance documentation.
- May prepare research presentations and draft manuscripts.
- Performs other job-related duties as assigned.
Minimum Qualifications
- Bachelor's degree.
- Four years of relevant experience.
Preferred Qualifications
- Analytical and detail oriented - seeks to understand.
- Grant education.
- Exceptional interpersonal, teamwork, and organizational skills and abilities to interact effectively at all levels and Intentional communicator.
Work Authorization Requirement:
This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
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