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Title:  Manager, Clinical Research

Division:  Duncan Cancer Center
Schedule:  Monday - Friday, 8:00 am - 5:00 pm
Work Location:  Houston, TX
Salary Range:  $77,029 - $115,000
FLSA Status:  Exempt
Requisition ID:  9642

Summary

This position will oversee the day-to-day operations of a robust clinical research program in breast medical oncology. This program supports the clinical research activities of approximately 7 breast medical oncologists, including trial start-up, regulatory maintenance, data management, and study coordination. This role will be responsible for the development and implementation of departmental standard operating procedures and best practices, as well as ensuring compliance with both institutional and federal guidelines surrounding the conduct of clinical trials. The Clinical Research Manager will directly manage a team of research coordinators and regulatory affairs associates.

Job Duties

  • Oversees regulatory support and maintenance for the entire clinical trial portfolio, including the preparation of amendments and continuing reviews for both internal and external regulatory bodies, as well as maintenance of the site TMF.
  • Oversees all aspects of clinical trial start-up. This will include internal collaboration with various departments to ensure successful execution of the clinical trial, as well as liaising with a sponsor or sponsor's representative; Keeps start-up timelines on track and notifies stakeholders of delays.
  • Supports investigators and clinical research staff with reporting, study monitoring, and site visits.
  • Develops, implements, and monitors research protocols, procedures, and processes.
  • Manages workloads for members of the clinical research team, including research coordinators and regulatory associates.
  • Works collaboratively with the Dan L. Duncan Cancer Center Clinical Trial Support Unit on center-wide projects and improvements.
  • Supervises clinical research and administrative staff; provides training and guidance on regulations and best practices.
  • 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.
  • Oversees data collection and documentation activities; queries databases and prepares reports; manages compliance documents.
  • Provides administrative support for several recurring meetings - including agenda preparation, completion and distribution of meeting minutes, and the development and implementation of meeting policies and procedures (as needed).
  • Serves as a subject matter expert to investigators as well as other research staff regarding compliance, research best practices, and logistics. 
  • Provides both regulatory and logistical support for investigator initiated trials.
  • Coordinates and aligns the needs of multiple stakeholders while shepherding a study through local approval procedures; this requires a thorough understanding of the approval process, best practices for structuring and timing submissions so as to obtain approval within a reasonable time frame.

Minimum Qualifications

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

Preferred Qualifications

  • Seven years of experience in a related field; prior management experience a plus.
  • Working knowledge of FDA regulations and ICH/GCP.
  • Prior experience with drug trials; oncology experience a plus, but not required.
  • Proficiency with Microsoft Office suite (Word, Excel, PowerPoint, Outlook).

 

 

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.

 9642

CA