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Manager, Clinical Research

Baylor College of Medicine
Texas, United States
Salary Not Specified
Posted Date
May 10, 2023


The section of Pulmonary, Critical Care, and Sleep Medicine is seeking a Clinical Research Manager for Dr. Rosas' pulmonary research lab. The Clinical Research Manager will be responsible for the management of daily operations of a clinical trial or research study, implementing standard operating procedures, ensuring institutional and federal compliance, managing financial aspects of clinical trials, and overseeing data collection and documentation activities.

Job Duties
  • Recruits, supervises, schedules, disciplines, and directs the daily activities of clinical research staff.
  • Supports investigators and clinical research staff with reporting, study monitoring, and site visits.
  • Develops, implements, and monitors research protocols, procedures, and processes.
  • Provides training and guidance on regulations and best practices to clinical and administrative staff.
  • Implements standard operating procedures (SOPs), ensures quality control, and maintains site certifications.
  • Assists in the preparation of grant proposals and other written materials.
  • Oversees data collection and documentation activities; queries databases and prepares reports; manages compliance documents.
  • Prepares activity and budget reports for use by the principal investigator (PI).
  • Acts as liaison between PI and sponsors on regulatory quality control and quality assurance matters.
  • Interfaces with regulatory bodies and other department management as needed.
  • Responsible for the clinical operations and logistical aspects of assigned Phase I/II/III trial from start-up to close-out.
  • Leads a global cross-functional Clinical Trial Team (CTT), composed of internal and external team members.
  • Ensures that clinical trial deliverables are met according to timelines to achieve study goals, while meeting Good Clinical Practice (GCP) guidelines. • Identifies issues and propose solutions. • Proactively assesses potential risks to the clinical study and propose mitigation plans.
  • Contributes to the development of clinical sections of regulatory documents such as: Investigators' Brochures, IND/NDA submission documents, responses to Health Authorities questions and other essential study documents. • Manages Contract Research Organizations (CROs) supporting the clinical trial to ensure data integrity and quality.
  • Supervises CRO during study start-up, such as site initiation visit (SIV) meeting planning, case report form development for database, study drug supply design and ordering, and review study site contracts and budgets. • Arranges periodic meetings with clinical investigators, administrators, and study staff to maintain good study health.
  • Provides oversight to the coordinators, conduct periodic quality review and study audit ready.
  • Provides review and input to the protocol feasibility assessment, development of study start-up materials such as the clinical trial protocol, protocol amendment(s), Informed Consent Forms, Pharmacy Manual, Monitoring Plan, Laboratory Manual, and site training materials of the protocol.
  • Collaborates with Study Medical Lead and KOLs to determine the medical and scientific needs, and apply them to the protocol and study logistics.
  • Monitors the study budget; review and approve study-related invoices.
Minimum Qualifications
  • Bachelor's degree.
  • Four years of relevant experience.
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.



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