Clinical Research Coordinator II

The ImagingNMD UF research team brings researchers from across the University of Florida campus, industry, and other institutions in a collaborative effort to advance the understanding and treatment of neuromuscular diseases, including Duchenne, Beckers, and Limb Girdle Muscular Dystrophies. This team facilitates clinical research studies and trials focused on neuromuscular diseases and is engaged in national and international collaborative research efforts. The ImagingNMD network is seeking a diligent, detail-oriented, and experienced individual to serve as the Clinical Research Coordinator II for these critical clinical research studies.

This full-time position within the Department of Physical Therapy, in the College of Public Health and Health Professions, is located in the Clinical Translational Research Building, at the University of Florida. The incumbent will work closely with principal investigators (PIs) and faculty to facilitate the implementation of research activities for both industry and NIH-sponsored clinical studies, focusing on interventional and non-interventional trials related to muscular dystrophy.

The incumbent will collaborate with principal investigators to efficiently coordinate participant assessments, and maintain data collection records for multiple federally and industry-sponsored clinical trials.. As a member of the ImagingNMD network, the Clinical Research Coordinator II works closely with investigators, physicians, nurses, and other key personnel to ensure compliance with protocol requirements. Primary responsibilities involve coordinating the clinical research activities of the ImagingNMD network, including assisting in the development of procedural manuals, scheduling research participants, facilitating key elements of study protocols, training research assistants, and maintaining compliance with regulatory bodies. Furthermore, the incumbent will serve as the primary liaison with national and international imaging sites within the ImagingNMD network and be responsible for maintaining vendor regulatory and participant visit related documents.

Responsible for coordinating multiple Magnetic Resonance Imaging (MRI) sites for international clinical trials and research studies. This includes:

• Managing assigned MRI sites with oversight of study execution 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, provide timely updates and guidance, address concerns or issues that arise, and seamless collaboration between the clinical research and data management teams.
• Oversee study execution, data collection and monitoring, and compliance with regulatory guidelines. Review internal documents and documents provided by MRI sites for compliance with regulatory guidelines.
• Provide training to research assistants for work related to clinical trials.
• Develop training materials. Update relevant study manual procedures, forms, and internal standard operating procedures (SOPs) as necessary.

Responsible for managing onsite research subject visits for interventional and non-interventional industry and federally funded studies. This includes:

• Coordinating participant screen and recruitment eligibility participation in various research projects at the Clinical and Translational Research Building.
• Schedule and coordinate participant tests and procedures including obtaining informed consent documents.
• Administer research assessments including but not limited to collecting medical history, MRI data acquisition, conducting physical function assessments, overseeing biospecimen collection and performing respiratory tests.
• Communicate with study physicians and principal investigators regarding research testing. Monitor safety and compliance throughout all procedures including but not limited to reporting protocol deviations and adverse events if applicable.
• Complete and maintain study documentation in accordance with sponsor and local, national, and international regulatory requirements in addition to university policies and procedures.
• Monitor and ensure internal compliance with study data requirements throughout the duration of ongoing clinical trials, as well as during critical study closeout phases.

Manage query resolution and problem solving. This includes:

• Addressing issues arising from the conduct of the program and its associated studies.
• Work with Imaging sites and internal teams to resolve queries.
• Coordinate reconciliation for study closeouts.
• Stay abreast of and disseminate relevant information regarding university regulations, policies, and contracts to ensure compliance and adherence across the studies.

Serve as a liaison between the University of Florida and study subjects. This includes:

• Initiating correspondence with the subject’s family and research team.

Design, develop, and lead special projects.

• At times this may include being the sole liaison with outside parties.

Bachelor’s degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.

• 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.