Summary

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.