Clinical Research Coordinator I

University of Florida•Gainesville, FL

1d•Onsite

About The Position

The ImagingNMD UF research team brings researchers from throughout UF campus, industry, and other institutions together in a collaborative effort to advance the understanding and treatment of neuromuscular diseases, including Duchenne, Beckers, and Limb Girdle Muscular Dystrophies. This research team facilitates clinical research studies and trials focused on neuromuscular diseases and is engaged in national and international collaborative research efforts. The Clinical Research Coordinator I for the ImagingNMD UF network plays a vital role in managing these critical clinical research studies, requiring diligence, attention to detail, and proven experience. This full-time, salaried position is located in the Department of Physical Therapy in the College of Public Health and Health Professions, located in the Clinical Translational Research Building, at the University of Florida. The incumbent will assist the Principal Investigator (PI) and faculty with the implementation of research activities for both industry and NIH-sponsored clinical trials, focusing on interventional and non-interventional trials related to muscular dystrophy. This position supports multiple industry-sponsored clinical trials and government-funded research studies. The incumbent will work as a member of the ImagingNMD Network with investigators, physicians, nurses, and other key personnel to ensure compliance with the protocol requirements and regulatory standards. Primary responsibilities involve assisting with the coordination of clinical research, including scheduling and assisting with research participant visits, assisting with key elements of study protocols, reading MR data, and maintaining compliance with regulatory bodies. The incumbent will serve as a liaison for national and international imaging sites within the ImagingNMD network and be responsible for maintaining vendor, regulatory, and participant visit-related documents. This position requires excellent communication, outstanding organizational skills, exceptional written and verbal communication skills, professionalism, and an ability to multitask.

Requirements

Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience

Nice To Haves

Prior experience with Clinical Trials.
Experience working with children.
Strong interpersonal and organizational skills.
Ability to work independently, coupled with the knowledge of when to seek advice.
Ability to manage multiple priorities and responsibilities.
Excellent organizational and communication skills.
Capacity to follow written procedures.
Ability to read, write, and understand English.
Familiarity with muscle anatomy.
Familiar with GCP guidelines and regulatory compliance requirements highly preferred.

Responsibilities

Assist with coordinating multiple Magnetic Resonance Imaging (MRI) sites for international clinical trials and research studies.
Manage assigned MRI sites as the primary liaison.
Coordinate training and certification of MRI site personnel.
Communicate with MRI site and enrollment site personnel to maintain open lines of communication, providing timely updates and guidance, address concerns or issues that arise, and collaborate between the clinical research and data management teams.
Assist with study execution, data collection and monitoring, and compliance with regulatory guidelines.
Review internal documents provided by MRI sites for compliance with regulatory guidelines.
Track expected and completed MRI visits for assigned sites based on protocol-specific timelines.
Conduct query resolution and document monitoring.
Work with imaging sites and internal teams to resolve queries.
Coordinate reconciliation for study closeouts.
Disseminate relevant information regarding university regulations, policies, and contracts to ensure compliance and adherence across the studies.
Assist with onsite research participant visits for interventional and non-interventional industry and federally funded clinical studies in compliance with FDA regulations and guidelines, while ensuring adherence to ImagingNMD UF standard operating procedures (SOPs) and study-specific manual of procedures (MOPs).
Assist in the daily operations of study-specific clinical research projects and communicate with study physicians, principal investigators, and other clinical research staff regarding research testing to ensure the study is conducted effectively.
Support study participant preparation at the MRI facilities and Clinical Research Center and assist with recording clinical data, including but not limited to collecting medical history, MRI data acquisition, and biospecimen collection.
Responsible for scheduling onsite study participant visits and assisting with participant tests and procedures.
Complete and maintain study documentation according to sponsor and local, national, and international regulatory requirements in addition to university policies and procedures.
Monitor study-specific electronic data capture tools to verify the completeness and accuracy of study data.
Monitor and ensure compliance with study data requirements throughout the duration of ongoing clinical trials, as well as during critical study initiation and closeout phases.
Facilitate communication between the University of Florida and study participants.
Initiate correspondence with the participants, their family, and/or research team and collaborators.
Complete the manual steps required in MR data.
Define the regions of interest in image slices, for further computation.
Identify the appropriate anatomical regions of interest and circle the boundaries as described in the study-specific MOPs.
Assist with MRI phantom building and shipping.
Assist with supply inventory for research study visits.
Complete other duties as assigned, including but not limited to, fulfilling training requirements, participating in professional development and continuing education, preparing reports.