Clinical Research Associate/Data Manager



Summary

The Clinical Research Associate (Data Manager) is responsible for leading and conducting data management activities for assigned clinical trials from start up to close out. The CRA ensures all study related clinical data management deliverables are completed with a high degree of quality and within study timelines. Performs day-to-day data management activities in compliance with ICH GCP, all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.

Job Purpose

Supports daily operations for a research study or clinical trial. Screens and enrolls study participants. Collects, enters, evaluates, and tracks research data. Under minimal supervision, oversees research data management activities for a specific disease site or cooperative program. Collaborates with leadership to monitor data quality, timeliness, and compliance. Tasks require a high level of organizational skills and the exercise of judgments and to determine proper course of action while following established standards.

Job Duties
  • Supports daily operations for research studies and clinical trials.
  • Coordinates project to ensure that implementation and prescribed activities are carried out in accordance with specified objectives. This includes, but is not limited to the following roles: Verifies informed consent; Confirms eligibility; Registers patients; Prospectively tracks information on internal and external study entrants; Completes Case Report Forms (CRFs); Responsible for timely entry of the data in the study database;
  • Ensures quality assurance. Evaluates data to ensure that protocol required events took place and monitors the reporting of data for accuracy and completeness. Monitors internal and external data to ensure that the study is being conducted in compliance with the FDA regulations. Ensures that these events are expeditiously reported to the Principal Investigator as well as to all regulatory agencies.
  • Participates in regular meetings with the Principal Investigator to review study data; Maintains research charts for internal and external study entrants; Corresponds with personnel at external institutions to ensure that data for patients from outside institutions are obtained as specified by the protocol. Sends and maintains copies of written requests for incomplete, inaccurate data or outstanding data.
  • Participates in planning and developing methods for project implementation and administration; coordinates project activities.
  • Reviews records and reports of activities to ensure that progress is being accomplished toward specified project objectives; recommends modifications to methods or procedures as required to redirect activities and ensure that objectives are met.
  • Prepares recurring reports for management use.
  • Assists with developing databases for the research projects.
  • Interacts with faculty, staff and students to promote the goals and objectives of the project.
  • Assists research coordinator with other study related tasks.


Minimum Qualifications
  • Bachelor's degree.
  • Two years of relevant experience.


Preferred Qualifications
  • Requires effective communication skills, both orally and in writing.
  • Requires experience with computer spreadsheets and database management.
  • Requires ability to understand and implement patient studies and protocols.


Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

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