Clinical Research Coordinator

1 week ago

Walnut Creek, California, United States Neurocentria, Inc. Full time

The Clinical Trial Associate (CTA) plays a crucial role in overseeing the management of clinical trial documentation, ensuring compliance with study protocols, ICH/GCP standards, and relevant regulatory requirements.

Key Responsibilities

Study Management and Execution:

  • Establish and maintain the electronic Trial Master File (eTMF) system as necessary.
  • Assist in the creation of essential documents, including regulatory templates, study binders, and presentations.
  • Coordinate the logistics of incoming and outgoing shipments as required.
  • Support the initial release of study medication by reviewing regulatory packets and managing study-drug distribution.
  • Contribute to the development of training materials specific to the study.
  • Engage in the planning and organization of investigator meetings.
  • Assist in the formulation of case report forms and contribute to the Electronic Data Capture (EDC) and Interactive Voice Response System (IVRS) specification processes.
  • Organize and maintain clinical research files, ensuring all documents are properly filed.
  • Provide support to regional Field Monitors as needed.
  • Communicate with study sites to address any arising issues.
  • Monitor and track all monitoring visit reports within SharePoint and the eTMF.
  • Responsible for tracking the progress of clinical trials, including providing status updates as required.
  • Participate in the review of clinical data at various levels, including case report forms and data listings.
  • Assist in the final approval of project-related documents, such as informed consent forms, monitoring plans, and protocols.
  • Engage actively in clinical team meetings, maintaining a professional demeanor.
  • Ensure training is current by reviewing and signing off on all Standard Operating Procedures (SOPs).
  • Identify and escalate issues as necessary.
  • Set up clinical trials and maintain oversight until the study concludes.
  • Support the study team with Institutional Review Board (IRB) submissions and updates.
  • Manage the calendar for study meetings.
  • Draft agendas for study meetings and document meeting minutes.
  • Complete all required corporate training on standards and policies by the designated deadlines.
  • Perform additional job-related duties as assigned.

Qualifications

  • A bachelor's degree in biology, life sciences, health sciences, healthcare administration, psychology, or business.
  • 1-2 years of experience in clinical trials, medical research, or a Contract Research Organization (CRO).
  • Familiarity with Good Clinical Practice (GCP) guidelines and Institutional Review Board (IRB) processes is essential.
  • Understanding of relevant regulatory agencies, such as the FDA, is preferred.
  • Strong organizational skills with meticulous attention to detail.
  • Excellent written and verbal communication abilities.

Desired Attributes

  • Self-motivated individual with a strong commitment to personal and professional growth.
  • Able to thrive in a dynamic and fast-paced environment.
  • Dedicated to achieving results and contributing to the strategic objectives of the organization.
  • Capable of navigating ambiguity and challenging established norms.
  • Adept at managing multiple projects with competing deadlines and priorities.
  • Strong communicator, capable of presenting key information to diverse audiences, including senior stakeholders.

Neurocentria, Inc. is an equal opportunity employer committed to fostering a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information, gender identity and expression, veteran status, or any other non-job-related characteristics as outlined by applicable laws.

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