Clinical Trials Manager

Georgetown University•Vinalhaven, ME

4d•$44,022 - $73,407•Onsite

About The Position

Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world. Job Overview 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. Work Interactions 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.

Requirements

Bachelor’s or Master’s degree and 3-5 years of experience or equivalent relevant work experience; e.g. each year or work experience may be substituted for each year of education required
Excellent organizational and communication skills with ability to work independently and collaboratively with investigators and subjects
Attention to detail is critical and must be self-directed with a solid base of management skills.
Must be able to manage multiple tasks
Must be able to demonstrate successful track records using analytical, organizational and problem-solving skills
Excellent interpersonal skills and ability to communicate professionally and clearly.
Solids writing skills include grammar, punctuation, composition and spelling.
Computer proficiency essential, with demonstrated knowledge of PC software programs including Windows, MS Office, internet and email.
Minimum two-years cognitive testing experience necessary.

Responsibilities

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.
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.
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.
Prepare for and facilitate research and monitoring visits.
Administer cognitive testing to subjects.
Manage multiple local and multi-center clinical trials.
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.
Provide support to the Principal Investigator (PI), co-investigators and all other study collaborators for neurology clinical trials.
Maintaining and facilitating regulatory documents, including IRB submissions, together with the Regulatory Manager.
Prepare dynamic training guides to promote seamless onboarding for new staff members in the Memory Disorders Program.
Work diligently – including troubleshooting for all Memory Disorders staff- within the OnCore system to manage study visit data and study visit payments to participants.
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.
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.
Requires interaction with patients, sponsors and CROs.