Project Manager, Research Support

Project Manager, Research Support

The University of Miami/UHealth Department of Neurology has an exciting opportunity for a full-time Project Manager, Research Support to work in Miami, FL.

Core Job Summary

The Project Manager, Research Support coordinates and leads efforts in a variety of research activities that are complex and wide in scope. Moreover, the Project Manager, Research Support operates with the goal of ensuring that the collection of data and administration of studies are performed efficiently and in compliance with applicable guidelines.

Core Responsibilities

• Aids in the evaluation of problems with workflow, organization, and planning and develops appropriate analytical approaches.
• Maintains multiple protocol books and chronicles manuscript preparation.
• Performs analyses of computerized datasets using standard packages to import, update, and manipulate datasets.

Department Specific Functions

The Project Manager, Research Support will join a team of about 20 talented clinical research professionals focused on the study of amyotrophic lateral sclerosis (ALS).

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.

• Oversight of research portfolio, ensuring that research protocols are executed appropriately
• Prepare IRB submissions and manage interactions with the central IRB for the Consortium's portfolio of studies
• 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
• Establish and update 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
• 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 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

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities, as necessary.

CORE QUALIFICATIONS

• Bachelor's degree in relevant field.
• Master's degree or a Doctorate degree from an accredited institution with clinical research experience preferred.
• Minimum 3 years of relevant experience, 5 years of experience preferred.
• Experience with Human Subjects' Research required
• Clinical Research Coordinator (or similar) certification preferred.
• Demonstrates excellent problem-solving skills and critical analyses abilities
• Project management skills.
• Willing to work in a highly collaborative environment.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.