Clinical Trial Administrative Assistant

IQVIAIrving, TX
1d$34,400 - $86,000

About The Position

Under the direction and supervision of the Clinical Trial Manager, this position is responsible for providing administrative support to the Data Entry and Research Coordinator teams for ongoing clinical studies. Essential and other important responsibilities and duties may include but are not limited to the following:

Requirements

  • Knowledge of appropriate software including Microsoft suite applications and Adobe Acrobat Pro.
  • Excellent interpersonal skills to deal effectively with research personnel.
  • Knowledge of ICH GCP, FDA, OHRP, OSHA and HIPAA guidelines pertaining to clinical research.
  • Excellent organizational skills to independently manage worklow.
  • Ability to prioritize quickly and appropriately with minimal guidance.
  • Ability to multi-task.
  • Ability to work independently and function as part of a team.
  • Clear and concise verbal and written communications.
  • Two to three years of administrative assistant experience preferred.

Responsibilities

  • Handles all study filing in eDOCs CTMS system for Research Coordinator team.
  • Maintain EDC and study portal system access for key study personnel, ensuring appropriate access levels.
  • Provide general administrative support to the data entry team, such as scheduling meetings, organizing documentation, and tracking upcoming data deadlines.
  • Collect and organize data related to query resolution, ensuring timely and accurate completion.
  • Participate in regular team meetings and contribute to discussions on process improvements and operational strategies to reduce query burden.
  • Act as a liaison between the DES, Clinical Trial Management Team, and other stakeholders, facilitating effective communication and collaboration.
  • Provides support and information to onsite and remote monitors as necessary and as directed by supervisor(s).
  • Attends all scheduled Principal Investigator monitoring calls in support of onsite and remote monitoring.
  • Attends meetings and briefings regarding clinical studies as required.
  • Ability to maintain a positive attitude with the research team.
  • Maintain professional demeanor with sponsors, monitors, and auditors.
  • Remains current with all required training.
  • Performs other duties as assigned.
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