Clinical Research Analyst

6 days ago

Kansas City, Missouri, United States Medix Full time

Job Overview

The
Clinical Research Analyst
plays a pivotal role in supporting clinical studies by managing initial patient validation, data entry, quality assurance, and study-related coordination. This position ensures research activities are conducted efficiently, accurately, and in full compliance with regulatory guidelines. The ideal candidate will possess strong attention to detail, excellent organizational skills, and the ability to thrive in a collaborative research environment.

Key Responsibilities

Patient Screening & Validation

  • Review medical records to confirm potential participants meet protocol eligibility criteria.
  • Collaborate with
    Principal Investigators (PI), Sub-Investigators (SI),
    and monitors to review edge cases and ensure adherence to clinical guidelines outlined in the study protocol.

Data Entry & Management

  • Accurately enter and maintain study data in research databases and
    Electronic Data Capture (EDC)
    systems.
  • Ensure timely documentation of participant information, study-related activities, and collected data.
  • Assist in managing and organizing study-related documents, ensuring compliance with
    Good Clinical Practice (GCP)
    guidelines.

Regulatory Compliance & Quality Assurance

  • Adhere to ethical and regulatory requirements, including
    Institutional Review Board (IRB)
    protocols and data privacy regulations such as
    HIPAA
    and
    GDPR
    .
  • Maintain detailed, well-organized study records to support audits and inspections.
  • Review peer data entries to ensure accuracy and data integrity.
  • Assist in monitoring study progress and promptly flagging any protocol deviations or compliance concerns.

Operational & Administrative Support

  • Communicate with clinical teams to facilitate patient participation and follow-up.
  • Coordinate study logistics, including
    scheduling participant visits, tracking study supplies,
    and facilitating data collection procedures.
  • Work closely with
    investigators, sponsors, and research staff
    to ensure the smooth execution of clinical studies.
  • Support the preparation of
    reports, summaries,
    and regulatory submissions as required.

Qualifications

  • Bachelor's degree
    in a relevant field (e.g.,
    Life Sciences, Public Health, Healthcare Administration
    ).
  • Experience in
    clinical research, data entry,
    or
    patient screening
    preferred.
  • Strong
    attention to detail
    and
    organizational skills
    .
  • Ability to
    manage multiple tasks
    and
    prioritize workload
    effectively.
  • Familiarity with
    Clinical Trial Management Systems (CTMS)
    and
    Electronic Data Capture (EDC)
    platforms is a plus.
  • Certification in Good Clinical Practice (GCP)
    is preferred but not required.

This role is essential in ensuring the
accuracy, integrity,
and
efficiency
of our clinical research operations. The
Clinical Research Analyst
will be instrumental in maintaining compliance and supporting the successful execution of research studies.

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