Manages the daily operations of clinical trials or research studies within the Office of Clinical Research (OCR), which provides centralized support to Investigators from different departments across the College who conduct studies spanning a variety of disease areas, both drug and device, at Baylor and affiliated hospitals (BSLMC, Harris Health - HCHD, VAMC, etc.). Implements standard operating procedures and ensures institutional and federal compliance. Manages financial aspects of clinical trials. Oversees data collection and documentation activities. Experience with a variety of disease areas, and drug and device studies a plus. This individual must be a flexible and detail-oriented professional who can quickly adapt to a variety of situations.
This position requires previous management experience in clinical research, managing trials from multiple PIs. Ability to manage a study team that can be scattered across campus, and not always in the same location. Ability to juggle multiple PIs. Ability to assist leadership in development and growth of team capacity to accommodate the growing clinical research agenda of the College. Must be a team player and open to cross-training and support of other team members on short notice. Ability to think outside of the box and be proactive. Good outward facing ability to interface with multiple departments across the college.
Manages research agenda for numerous PIs across the College, as requests are received by the OCR.
Implements standard operating procedures (SOPs), ensures quality control, and maintains site certifications.
Ensures institutional and federal compliance.
Participates in study feasibility and central OCR feasibility processes for prioritization of study activity.
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.
Arranges regular meetings with PIs, OCR leadership, and study team for update reports and process improvement
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.
May prepare research presentations and draft manuscripts.
Four years of relevant experience. Degrees in lieu of experience will not be accepted.
We invite you to learn more about our benefits (bcm.edu/careers/benefits) including medical, dental, and vision insurance, tuition reimbursement, incentive-based wellness program, and more.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care.
- Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective.
- Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve.
- Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.