Clinical Trials Manager, Department of Neurology/Memory Disorders – Georgetown University. Participates in clinical trial set up, execution, documentation, education/recruitment, and provides general data management of the most complex clinical studies in the Department of Neurology, Memory Disorders Program. As clinical trials manager, responsibilities include review and mastery of clinical research documents (protocols, case report forms, reports and statistical analysis), monitoring recruitment and retention, adherence to study visit schedule, timely data entry (develops data management plans), compliance with all study procedures including close-out and training of other staff members on protocol measures and GU clinical research policies as needed. Responsible for patient cognitive testing (minimum two-years cognitive testing experience necessary), caregiver communication and interview, chart review and data organization using various web-based databases.
The Clinical Trials Manager will also prepare for and facilitate research and monitoring visits as well as administer cognitive testing to subjects. The incumbent will manage multiple local and multi-center clinical trials and will need to be detail-oriented with a solid base of management skills and interpersonal skills. The individual is expected to have working knowledge of compliance policies with respect to the clinical regulatory environment and requires little to no supervision to perform all job functions. Acts as liaison with clinicians, pharmaceutical companies and the federally-funded Alzheimer’s Disease Research Institute (ATRI) to implement studies and to meet all data timelines, in part to ensure timely and accurate study payments to GU. Corresponds directly with study sponsors to facilitate subject participation, submits subject visit information and resolves data queries. The position will provide support to the Principal Investigator (PI), co-investigators and all other study collaborators for neurology clinical trials. The manager is also responsible for maintaining and facilitating regulatory documents, including IRB submissions, together with the Regulatory Manager. The clinical trials manager will also prepare dynamic training guides to promote seamless onboarding for new staff members in the Memory Disorders Program and will work diligently – including troubleshooting for all Memory Disorders staff- within the OnCore system to manage study visit data and study visit payments to participants. The manager will be required to obtain and retain all necessary certifications in order to perform the position effectively.
Works as part of a team to establish effective management of clinical trials within the Department of Neurology, Memory Disorders Program. Recruit, conduct, establish and organize, document and maintain approval for these trials. The position will provide support to the Principal Investigator (PI), co-investigators and all other study collaborators for Memory Disorders Program clinical trials. Works with PIs, fellows, subjects and team members to conduct safe, accredited clinical trials in the Department of Neurology.
Operates with a strong understanding of current GU policies and SOPs related to research and compliance. Works under the direct supervision of the Research Director Neurology/Memory Disorders. This position
also requires interaction with patients, sponsors and CROs.