Clinical Trials Management Specialist

2 weeks ago

Garden Grove, California, United States National Institute of Research, Inc. Full time
Job Overview

The National Institute of Research, Inc. is a prominent organization specializing in the management of clinical trials across various sites. We pride ourselves on delivering exceptional Phase 1 to Phase 4 trial management services to our extensive network of healthcare professionals. With over three decades of expertise, we are recognized as a leading entity in the clinical research field.

We are currently looking for a dedicated and experienced individual to join our team as a Senior Clinical Research Coordinator (CRC II). This position plays a crucial role in overseeing and coordinating clinical research projects under the guidance of the principal investigator (PI) and the clinical research manager. The CRC II will ensure adherence to all regulatory standards, uphold data integrity, and manage the logistics essential for the successful execution of clinical trials.

Key Responsibilities
  • Oversee and coordinate clinical trials from inception to conclusion.
  • Develop and maintain essential study documentation, including protocols, informed consent forms, and case report forms.
  • Ensure compliance with Good Clinical Practice (GCP) guidelines and all relevant regulations.
  • Screen, recruit, and enroll participants for studies.
  • Facilitate the informed consent process for participants.
  • Schedule and conduct study visits, follow-ups, and assessments.
  • Maintain clear communication with study participants to ensure adherence to protocols.
Administrative Responsibilities
  • Collect, process, and maintain accurate study data.
  • Input data into electronic data capture systems, ensuring timely entry.
  • Monitor data quality and address any data discrepancies.
  • Prepare and submit regulatory documents to Institutional Review Boards (IRBs) and other governing bodies.
  • Ensure compliance with all regulatory obligations, including the reporting of adverse events and protocol deviations.
  • Provide training and mentorship to junior research staff and clinical research coordinators.
  • Stay updated with industry best practices and regulatory changes through continuous professional development.
Clinical Responsibilities
  • Maintain study-related documentation and records in accordance with regulatory requirements.
  • Act as a liaison between the PI, research team, study participants, and external stakeholders.
  • Coordinate with study sponsors, monitors, and other external entities.
  • Participate in study team meetings and provide regular updates on study progress.
Qualifications
  • Bachelor's degree in a relevant field (e.g., nursing, life sciences, public health) is preferred.
  • A minimum of 2-3 years of experience in clinical research coordination.
  • Local residency is preferred.
  • Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) is advantageous.
  • Strong understanding of GCP, FDA regulations, and IRB procedures.
  • Excellent organizational, communication, and interpersonal skills.
  • Proficiency in electronic data capture systems and Microsoft Office Suite.
  • Ability to work independently and collaboratively within a multidisciplinary team.
  • Detail-oriented with strong problem-solving capabilities.
Job Type

Full-Time

Benefits
  • Medical, Dental, Vision, 401K, PTO, and Bonuses

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