Clinical Trials Administrative Coordinator

2 weeks ago

Ocala, Florida, United States Renstar Medical Research Full time
Job Overview

Position Summary:

As a Clinical Trials Administrative Coordinator at Renstar Medical Research, you will be essential in supporting the initiation, management, and conclusion of Clinical Trials. This position demands exceptional attention to detail, strong organizational capabilities, and a dedication to upholding the highest standards in document oversight.

Key Responsibilities:

  • Prepare, manage, and update regulatory and eRegulatory documentation for review by internal and external monitoring and auditing teams.
  • Engage with auditors and monitors to address regulatory findings during their evaluations.
  • Update staff credentials, including CVs, medical licenses, and training certifications as necessary.
  • Facilitate the onboarding and offboarding of personnel involved in studies.
  • Document staff training and maintain updated logs as required.
  • Alert team members and management regarding upcoming training expiration dates.
  • Oversee the archiving process for completed studies in accordance with standard operating procedures.
  • Maintain a thorough understanding of professional guidelines and ethical standards pertinent to clinical research.
  • Ensure compliance with Good Clinical Practice (GCP) regulations, patient confidentiality (HIPAA), and other relevant legal requirements.
  • Manage study completion activities, including closeout procedures, reporting, and archiving of both physical and electronic study files, ensuring thoroughness and continuity of all documentation.
  • Identify and communicate significant regulatory concerns or issues to management.
  • Perform additional tasks as assigned to achieve departmental objectives.

Qualifications and Skills:

  • Strong organizational and time management abilities.
  • Exceptional attention to detail and accuracy.
  • Professional and effective oral and written communication skills.
  • Familiarity with relevant regulatory standards and compliance is advantageous.
  • Ability to work autonomously or collaboratively within a team.
  • Capable of multitasking and thriving under pressure.
  • Strong reading comprehension skills.

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