This position is no longer open for applications

The ALS Center at the University of Miami has an exciting opportunity for a Project Manager, Research Support (Clinical) to join a team of about 20 talented clinical research professionals focused on the study of amyotrophic lateral sclerosis. The project manager will play a leadership role in managing the activities of a multi-center clinical research consortium that forms part of the National Institutes of Health (NIH) Rare Diseases Clinical Research Network. The successful candidate will have significant clinical research, proficiency with working through a central IRB to coordinate regulatory approvals for multiple ongoing studies, outstanding inter-personal and communication skills, enjoy working as part of a highly collaborative and synergistic team, and be passionate about producing high quality work that meaningfully advances scientific progress.

PRINCIPAL DUTIES AND RESPOSIBILITIES include the following:

• Oversight of research portfolio, ensuring that research protocols are executed appropriately
• Manage financial and material resources of the research portfolio to ensure success completion of goals and objectives
• Attend study meetings to represent the research unit and grow in knowledge of data quality and the federal regulations governing clinical research.
• Prepare IRB submissions
• Develop research instruments (protocol specific source documentation, lab forms, and template notes) necessary for study execution if needed Oversee internal and external processes related to each study’s deliverables in accordance with the associated grant and/or contract expectations, timelines, and terms
• Establishes and updates timelines and processes to guide implementation of protocols
• Maintain databases of deliverables and reporting requirements for all active research projects, proposal-related documents/information (biosketches, SOPs, facilities, etc.)
• Meet regularly with principal investigator(s), and protocol team leaders to review patient participation, data accuracy and overall project progress
• Control quality of source documentation and research integrity
• Detect and help solve logistical, technical and patient related problems as they pertain to protocol participation.
• Coordinate laboratory specimen processing and handling with appropriate lab supervisors.
• Act as liaison between the Neuromuscular Division and other departments/centers/institutes as necessary for protocol implementation and execution
• Manages research databases and follows data management plans.
• Participates in internal study reviews and assures compliance with outside monitoring
• Responsible for up-to-date knowledge of UM systems associated with research management
• Work closely with PI and Administrator in performing activities associated with a grant close-out (i.e., accounting, final reports, record archive, web site closure)
• Provides timely financial and research reports to the PI/Administrator.
• Assist with coordination of specific research studies as needed.
• Meet with, and coordinate activities related to industry-sponsored clinical trials

Preferred Qualifications:

• Doctorate degree or a Master's degree from an accredited institution with clinical research experience.
• Clinical Research Coordinator (or similar) certification.
• Grants management experience.
• Demonstrates excellent problem-solving skills and critical analyses abilities
• Project management skills.
• Strong research background with publication experience.
• Must have excellent people skills.
• Willing to work in a highly collaborative environment.
• Must be very adoptable and change projects instantaneously.
• Ability to write reports.