Clinical Trials Manager, Department of Neurology - Georgetown University Medical Center

6 days left

Location
Washington D.C.
Posted
Apr 05, 2017
Closes
Apr 29, 2017
Function
Management
Industry
Education, Healthcare
Hours
Full Time
Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.

Requirements

Clinical Trials Manager, Department of Neurology - Georgetown University Medical Center

Georgetown'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
  • Delivery of cutting edge neurological care to our patients.

The Clinical Trials Manager is responsible for recruitment and implementation of a novel patient-centered specialty home research project - the study (MS-ADVANCE) enrolls and tracks up to 500 patients seen in the Georgetown Multiple Sclerosis Center.  S/he recruits and enrolls all patients, enters all patient data at baseline and follow-up visits, and liaises between sponsor and groups affiliated with the study. S/he ensures that patients are completing questionnaires at home and answering all questions that they have regarding the study, consents patients into the study, maintains the site file with required documentation, and assists with test tracking and follow up required for coordination of care within the Georgetown MS Center.  Reporting to the Director of Clinical Trials, the Clinical Trials Manager has duties that include but are not limited to:

  • Provides clinical data management support.
  • Participates in the review of clinical research documents (for example, Protocols, Case Report Forms, Reports and Statistical analysis).
  • Reconciles electronic data transfers of site data to sponsor.
  • Performs maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trials (for example, compiling master user lists and activating/deactivating user accounts).
  • Performs training on study trial for EDC and create user guides.
  • Ensures clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock (for example, data reconciliation and/or coding).
  • Assists in defining and/or create data listings, summary table validation, data specifications and/or processes data transfers in preparation for statistical review and/or data management audit.
  • Coordinates the archiving of study databases and related documents.
  • Performs close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
  • Coordinates and communicates with DB vendors on consistent basis to address Clinical teams' requests, project plans, and/or eCRF development activities.
  • Collaborates with IT and implementation team(s) to address Clinical application requests and/or changes to clinical database systems.
  • Participates in the preparation and presentation of data, including original research project to be presented in 2017-2018 calendar year.

Requirements

  • Bachelor's degree - thought Master's preferred.
  • Previous experience in a clinical setting, specifically clinical trials
  • CITI Human Subjects Protection, HIPAA, and GCP training
  • Knowledge of multiple sclerosis and experience working with patients

Submission Guidelines:

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Please note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume  for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.

Need Assistance:

If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or ideaa@georgetown.edu.

Need some assistance with the application process? Please call 202-687-2500

EEO Statement:

Georgetown University is an Equal Opportunity/Affirmative Action Employer fully dedicated to achieving a diverse faculty and staff.  All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex, disability status, protected veteran status, or any other characteristic protected by law.