Senior Clinical Trials Manager, Department of Neurology Georgetown University Medical Center
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Senior Clinical Trials Manager, Department of Neurology - Georgetown University Medical Center
Georgetown University Medical Center's Department of Neurology is dedicated to three major goals: Neurological education of students, residents and physicians, advancement of our scientific knowledge via research which will improve the diagnosis and treatment of neurological disorders, and delivery of cutting edge neurological care to our patients.
The Senior Clinical Trails Manager participates in clinical trial set up, execution, documentation, education/recruitment, and provides general data management in the Department of Neurology's Memory Disorders Program. They act as a liaison with clinicians, pharmaceutical companies, and the federally funded Alzheimer's Disease Therapeutic Research Institute (ATRI) to implement trials; and correspond directly with study sponsors to facilitate subject participation, submit subject visit information and resolve data queries. Reporting to the Director of Clinical Trials, and providing support to the Principal Investigator (PI), Coinvestigators, and all study collaborators for neurology clinical trials, the Senior Clinical Trials Manager has duties that include but are not limited to:
Participate in clinical trial set up, execution, documentation and general data management (submission of data and resolution of queries) of multiple clinical trials in the Department of Neurology
Ensure proper certification and training of staff members involved in the Clinical Trials Manager's trial panel
Monitor study recruitment and retention, adherence to study schedule, timely data entry and compliance with all study procedures
Manage all aspects of study recruitment, patient interview and patient/caregiver protocol instruction, enrollment and follow-up procedures for Memory Disorders Program Clinical Trials
Prepare for and lead research visits in the CRU (source documents, medication authorizations and medical records), and facilitate study drug ordering and account set-up with research pharmacy
Administer cognitive testing to patients and interview caregivers
Prepare and maintain supply inventory and documents to ensure that all required protocol procedures take place in study visits
Host site initiation and interim monitoring visits as well as GU or other audits
Administrative and Financial
Maintain and facilitate related regulatory documents and correspondence
Master study protocols and facilitate patient-physician communication during and between study visits
Manage chart review and data collection using web-based software
Organize documents necessary for IRB submissions and budget/financial submissions
Provide support to the Principal Investigator (PI), co-investigators, and all other study collaborators for Memory Disorders Program Clinical Trials
Correspond directly with study sponsors to facilitate subject participation, submit subject visit information, and resolve data queries
Bachelor's degree - Master's preferred
3 to 5 years of experience (each year of work experience may be substituted for each year of education required)
Excellent organizational and communication skills
Ability to work independently and collaboratively with investigators and subjects
Attention to detail
Self-directed with a solid base of management and interpersonal skills
Ability to manage multiple tasks
A demonstrably successful record of accomplishment using analytical, organizational and problem-solving skills
Excellent interpersonal skills and ability to communicate professionally and clearly
Working knowledge of compliance policies regarding the clinical regulatory environment
Solid writing skills including grammar, punctuation, composition, and spelling
Computer proficiency, with demonstrated knowledge of PC software programs, including Windows, MS Office, Internet and email
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