Clinical Research Administrator

2 weeks ago


Augusta, Maine, United States InsideHigherEd Full time


Clinical Research Specialist

Job Summary

The Clinical Research Specialist plays a vital role in the execution of clinical trials, providing advanced administrative and technical support. This position is responsible for managing multiple large-scale, multi-center clinical studies that are investigator-initiated, as well as those sponsored by federal and industry partners.

Key Responsibilities

Responsibilities include, but are not limited to:
  • Developing new clinical trial research protocols for submission to the Institutional Review Board (IRB), ensuring compliance with all relevant regulations and institutional policies.
  • Overseeing regulatory activities related to the management of ongoing clinical research protocols, including amendments, financial disclosures, and reporting of adverse events.
  • Uploading regulatory documents into relevant systems and providing support to clinical investigators and staff, acting as a liaison between sponsors, investigators, and the IRB.
  • Creating and maintaining training schedules for research faculty and staff, ensuring adherence to compliance best practices and facilitating continuing education opportunities.
  • Conducting quality control inspections of clinical trials to ensure regulatory compliance and performing other job-related duties as assigned.


Qualifications

Required qualifications include a Master's degree in a relevant field such as chemistry, biology, or health sciences, along with experience in research or clinical trial settings. Alternatively, a Bachelor's degree with a minimum of three years of research or clinical experience may be considered.

Preferred Qualifications

Certification as a Clinical Research Professional or similar credentials is preferred.

Skills and Abilities

The ideal candidate will possess a strong understanding of FDA and GCP regulations, along with proficiency in Microsoft Office and other relevant software. Excellent communication skills, attention to detail, and the ability to maintain confidentiality are essential for success in this role.

Work Environment

This position promotes a collaborative and customer-focused environment, emphasizing superior service to all stakeholders involved in the research process. The organization is committed to fostering a diverse and inclusive workplace, welcoming applicants from various backgrounds and experiences.

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