Clinical Trials Manager

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.

Requirements

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 and Qualifications

• 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.

Work Mode Designation

This position has been designated as On-Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position’s mode of work designation. Complete details about Georgetown University’s mode of work designations for staff positions can be found on the Department of Human Resources website:https://hr.georgetown.edu/mode-of-work-designation.

Pay Range:

The projected salaryor hourly pay range for this position which represents the full range of anticipated compensation is:

Compensation is determined by a number of factors including, but not limited to, the candidate’s individual qualifications, experience, education, skills, and certifications, as well as the University’s business needs and external factors.

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Need Assistance:

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Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website.

EEO Statement:

GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law.

Benefits:

Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.