Summary
We are seeking a Manager, Clinical Research to join our growing Phase 1 oncology research program. This position will manage and oversee the daily operations of Phase 1 clinical trials, including participating in feasibility assessments for trial evaluation and selection; screening patients for eligibility; managing study participant visits; collaborating with internal and external BCM partners; implementing and supporting the development of departmental standard operating procedures while ensuring institutional and federal compliance; supervising Phase 1 research coordinators; and overseeing data collection and documentation.
Job Duties
Generic Duty
- Oversee Phase 1 clinical trials and clinical research staff.
Specific Position Duties
- Coordinate complex Phase 1 clinical research studies.
- Manage and supervise Phase 1 clinical research and data coordinators (currently 5 positions, with opportunity for growth).
- Develop, implement, and optimize processes and standard operating procedures for Phase 1 trials in collaboration with leadership.
- Schedule, coordinate, and participate in internal feasibility meetings to evaluate potential trials.
- Coordinate and participate in pre‑site and site initiation visits with sponsors.
- Screen patients for study eligibility and manage study participant visits.
- Collaborate closely with internal and external BCM partners at affiliate institutions to support study execution.
- Oversee timely, accurate data collection and data entry in compliance with protocol and regulatory requirements.
- Build and maintain collaborative relationships with leadership across BCM and affiliate institutions to support ongoing and future clinical research success.
- Data collection and entry.
- Staff supervision (recruitment, hiring, and on-going performance management).
- Collaboration with leadership at BCM and external affiliate partners.
- Feasibility management (evaluate potential trial opportunities with leadership and management and engage with sponsors, assist with coordinating early feasibility evaluation tasks).
- SOP implementation.
- Performs other job-related duties as assigned.
Minimum Qualifications
- Bachelor's degree.
- Four years of relevant experience.
Preferred Qualifications
- Master’s degree.
- Six years of clinical trials experience.
- Two years of supervisory experience.
- Phase I research experience.
- Oncology experience.
- Experience with EPIC.
- CCRP or equivalent research certification.
- Bilingual in Spanish preferred, but not required.
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.