Clinical Research Data Monitor - Radiation Oncology

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Job ID: 54551
Area of Interest: Professionals
Location: Baltimore, MD US
Hours of Work: 7-7
Job Facility: University of Maryland Medical Center
Employment Type: Full Time
Shift: DAY
What You Will Do:

The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification.  These are not to be construed as an exhaustive list of all job duties performed by personnel so classified.

  • Ensures that sponsor, investigator, and study team adhere to all current regulations and requirements, applicable GCP guidelines, relevant certifications, and local policies and standard operating procedures.
  • Verifies that all research staff and facilities have adequate qualifications and resources, and these remain adequate throughout the trial.
  • Adheres to monitoring plan protocols; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.
  • Monitors clinical trial progress through a combination of data review and on site monitoring visits at each of the department’s practice sites.
  • Verifies that trial data are consistent with patient clinical notes and other source documentation (source data verification/review).
  • Verifies that source data/documents and other trial records are accurate, complete, and maintained.
  • Communicates deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the Investigator.
  • Independently coordinates ongoing and upcoming monitoring assignments.
  • Meets expected timelines for completion of monitoring activities and submission of written monitoring reports.
  • Assists in the development and writing of clinical trial monitoring plans.
  • Assists in the design of study protocol, case report forms, and informed consent forms for sound and thorough data collection to support the study through the approval process.
  • Provides recommendations and guidance to study specific monitoring teams and assists in audit readiness and preparation.
  • Participates in regular monitoring team group meetings. 

What You Need to Be Successful:

  • Bachelor’s degree in a Clinical, Health, Life Science, or related discipline.
  • Two years of experience in data monitoring in academic medicine, oncology, or an equivalent field within healthcare, is required.
  • One year of experience in radiation oncology preferred.
  • Clinical research experience is preferred, including: CRF (Case Report Form) creation, development, and design; and knowledge of National Cancer Institute’s cancer Biomedical Informatics Grid (caBIG), NCI CTCAE, FDA regulations, MedDRA, and ICH/GCP guidelines.
  • Working knowledge of Good Clinical Practices, including 21 CFR Part 50, 54, 56, 312, 314, and ICH Guidelines is expected. 
  • Requires high level critical thinking skills and the ability to function independently.
  • SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) certification preferred.
  • Willingness to travel up to 25% of time

We are an Equal Opportunity/Affirmative Action employer.  All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. 
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