Research - Laboratory/Non-Laboratory, Staff/Administrative
Clinical Trials Coordinator, Department of Neurology Georgetown University Medical Center
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Clinical Trials Coordinator, 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 Clinical Trials Coordinator participates in clinical trial set up, execution, documentation, education/recruitment, and general data management in the Department of Neurology, Memory Disorders Program. Their responsibilities include monitoring recruitment and retention, adherence to study visit schedule, timely data entry and compliance with all study procedures, as well as patient interview, chart review and data organization using various web-based databases, as well as acting as liaison with clinicians, pharmaceutical companies and the federally funded Alzheimer's Disease Therapeutic Institute (ATRI) to implement trials, and corresponding directly with study sponsors to facilitate subject participation, submits subject visit information and resolves data queries. Reporting to the Director of Clinical Trials for Neurology, the Clinical Trials Coordinator has duties that include but are not limited to:
Participate in clinical trial set up, execution, documentation, and general data management of multiple clinical trials
Ensure proper certification and training of staff members involved in the CRC's trial panel
Monitor study recruitment and retention, adherence to study schedule, timely data entry, and compliance with all study procedures
Administers all aspects of recruitment, patient interview and patient/caregiver protocol instruction, enrollment and follow-up procedures
Prepare for and lead research visits in the CRU (source documents, medication authorizations, and medical records)
Administer cognitive testing to patients and interview caregivers
Prepare and maintain supply inventory and documents to ensure that all required protocols take place in study visits
Maintain and facilitate related regulatory documents and correspondence
Master study protocols and facilitate patient-physician communication during and between study visits
Administer chart review and data collection using web-based software
Organize documents necessary for IRB submissions and budget/financial submissions
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
1 year of health-related or research experience (a Master's degree may be substituted year of described experience)
Excellent organizational and communication skills - to include writing skills of grammar, punctuation, composition, and spelling
Ability to work independently and collaboratively with investigators and subjects
Attention to detail
Self-direction with a solid base of management skills
Ability to multi-task
Successful track record 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
Computer proficiency, to include knowledge of PC software programs including Windows, MS Office, Internet and email
Willingness and ability to obtain and maintain all necessary certifications in order to perform the position effectively
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