Clinical Research Manager

Benefits

Qualifications

• •Must be a Registered Nurse with a current license in the state of Colorado

Responsibilities

• •The main responsibility of the Clinical Research Manager is to act as a liaison with sponsors to oversee clinical trials of medical devices and health tech (Phases 0-2), ensuring compliance with protocols and regulatory standards and directly manage a team of clinicians
• •Leads a team of clinicians and technicians in carrying out complex study protocols:
• •Management may include multiple concurrent studies
• •Studies may require multiple visits by participants
• •Studies may require travel to other states
• •Responsible for understanding protocol requirements and utilizing critical thinking skills
• •Tracks study progress in terms of data collection requirements and assists recruitment team by communicating screening goals
• •Creates case report forms, based on written protocol
• •Develops, completes, and maintains source documents
• •Documents all aspects of trial progress, including adverse events, protocol deviations, and device deficiencies; enrollment and screening logs; device accountability; and all documentation required for the Trial Master File
• •Responsible for maintaining and completing Case Report Forms in agreement with the source documentation and in accordance with the study protocols
• •Assures clinical supply accountability for assigned trials
• •Responsible for securing all sponsor-supplied devices and equipment
• •Communicates regularly with sponsors and with executive management regarding study design recommendations; study progress and status; mitigation strategies; and all aspects of the study from start to finish
• •Has the ability to directly supervise employees that perform data analysis and clinical execution
• •Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws
• •Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems
• •14 more items(s)