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Company: MedStar Medical Group
Location: Washington, DC
Career Level: Entry Level
Industries: Not specified
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Description

General Summary of Position
Facilitates the research effort of the clinical research center by assisting with collection and management of data in compliance with GCP and FDA regulations.


Primary Duties and Responsibilities

  • Contributes to the achievement of established department goals and objectives and adheres to department policies, procedures, quality standards, and safety standards. Complies with governmental and accreditation regulations.
  • Consistently demonstrates support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with, rules, regulations, policies, and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner.
  • Contacts study participants to schedule follow up appointments, updates medical history records and identifies outcomes relevant to the study. Communicates with sponsors, investigators, clinical monitors and colleagues to ensure effective clinical trial implementation and progress.
  • Maintains accurate regulatory files, computer databases and supply inventories.
  • May have to contact medical records departments from various medical facilities to request participant's medical records. Maintains personnel and sample inventories following laboratory protocols.
  • Assists Clinical Research Coordinator with preparing for and conducting research patient visits as appropriate.
  • Collects, processes, stores and ships biospecimens and/or materials as applicable and according to each protocol.
  • Complies with quality assurance procedures and medical policies. Manages appropriate logs.
  • Completes and maintains required training for routine packaging, labeling and transporting of biological materials and certification activities.
  • Assists with project development, coordination, monitoring, implementation, execution and close-out. May prepare and analyze regular reports of research activity, including MHRI monthly billing forms. IRB continuations and terminations, and patient enrollment logs.
  • Communicates project status with research team.
  • May coordinate and complete research for CRI trials in accordance with FDA and GCP guidelines. Coordinate protocol implementation and document processing for clinical trials, including but not limited to, patient screening & recruitment, informed consent process, study enrollment and patient follow up. Monitor patient study progress to fulfill protocols and sponsor requirements (complete all study documents in a timely manner), based on department assigned.
  • May provide clerical support to Clinical Research Coordinators, including but not limited to photocopying, data collection, data transcription and filing.
  • Participates in multidisciplinary quality and service improvement teams as appropriate. Participates in meetings, serves on committees and represents the department and hospital/facility in community outreach efforts as appropriate.


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    Minimum Qualifications
    Education

    • Associate degree or higher degree in a health care or related discipline required, or equivalent experience required

    Experience

    • 1-2 years experience in health care setting preferred
    • Research experience preferred

    Knowledge, Skills, and Abilities

    • Strong Verbal and written communication skills.
    • Basic computer skills including use of Microsoft Office suite.
    • Ability to work independently and meet strict deadlines.


    This position has a hiring range of $18.33 - $31.61

     


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