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Senior Clinical Research Coordinator

2 months ago

Los Angeles, California, United States Medix™ Full time

POSITION OVERVIEW

The Clinical Research Coordinator II (CRC II) plays a pivotal role in the management of our clinical research initiatives, overseeing the daily operations of various intricate trials across multiple therapeutic domains and research stages. This position is crucial for ensuring effective study execution and compliance with established protocols and regulations.

KEY RESPONSIBILITIES

Oversee Research Operations:

  • Collaborate with Principal Investigators (PIs) to guide participants through the informed consent process and conduct ongoing assessments and visits.
  • Provide comprehensive management for assigned clinical trials from initiation to completion.
  • Ensure patient safety by enforcing adherence to regulatory standards and study protocols throughout the trial lifecycle.
  • Facilitate communication with study sponsors, contract research organizations (CROs), vendors, and PIs.

Recruit and Enroll Participants:

  • Identify and enroll suitable participants for both ongoing and new clinical trials through collaboration with PIs and utilization of study portals.
  • Manage all aspects of the trial process, including feasibility assessments, institutional review board (IRB) submissions, data collection, quality assurance audits, and regulatory compliance.
  • Oversee study materials, supplies, and ensure effective communication among study teams.

Ensure Data Integrity and Processes:

  • Manage the clinical trial management system (CTMS) for various tasks, including new study setups, participant recruitment, medical record reviews, adverse event tracking, regulatory document preparation, and study visit scheduling.
  • Oversee accurate and timely data entry into electronic data capture (EDC) systems, including those managed by trial sponsors and CROs.
  • Work closely with PIs and team members to ensure data quality through independent monitoring and adherence to standard operating procedures (SOPs), good clinical practice (GCP), and applicable regulations.
  • Maintain accurate participant logs and manage study-related financials.
  • Archive records in accordance with SOPs.

Develop Clinical Research Expertise:

  • Gain in-depth knowledge of study protocols through collaboration with PIs.
  • Support new site initiation, study qualification, and activation, as well as equipment procurement and installation, ensuring all trial infrastructure is adequately established.
  • Provide support to colleagues by offering backup assistance, training new team members, and enhancing research processes.
  • Uphold the highest standards of confidentiality, attendance, and punctuality.

QUALIFICATIONS

  • Bachelor's degree in a health-related field.
  • A minimum of 3 years of experience in a research role within an institution conducting industry-sponsored, interventional clinical trials for investigational drugs.
  • Certification in GCP and IATA is required.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), CTMS, EDC systems, and electronic medical records (EHR/EMR) is preferred.
  • Exceptional organizational, time management, and multitasking abilities.
  • Strong interpersonal and communication skills, with the capacity to build rapport with diverse populations.
  • Meticulous attention to detail and accuracy in data collection and documentation.
  • Able to work independently and collaboratively in a fast-paced environment.

COMPENSATION AND BENEFITS

  • Competitive salary with potential for growth, along with meaningful equity options.
  • Paid time off (PTO) including vacation, sick leave, and holidays.
  • Comprehensive healthcare benefits (medical, dental, vision) and retirement plan (401(k)).