Clinical Research Coordinator

Overview

Unique opportunity to make an Impact in the healthcare industry
. Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, with a national presence in the Metro-Detroit Region, Texas, Illinois, Nebraska, and North Carolina. We are known for providing high-quality data for clinical research trials. Revival is growing and seeks qualified professionals who want to grow and learn with us.

The role of a Clinical Research Coordinator builds on the foundational responsibilities of an Assistant Clinical Research Coordinator, with more autonomous management of clinical research activities under moderate supervision. This requires a blend of certifications, knowledge of clinical trial processes, regulatory compliance, and practical skills to manage both operational and administrative aspects of clinical studies.

• Regulatory Document Management:
  Manage essential regulatory documents, including Institutional Review Board (IRB) submissions and safety reports, ensuring compliance with regulators and guidelines (e.g., FDA, DSMB).
• Data Management:
  Complete and maintain accurate source documentation and data entry. Address queries and action items promptly to ensure data integrity and timeliness. Perform E-source data entry and maintain real-time data accuracy, as applicable.
• Regulatory Submissions and Communications:
  Submit necessary documents to regulatory authorities and/or review/monitoring boards, including DSMB and independent safety officers, in a timely and compliant manner.
• Site and Study Visit Facilitation:
  Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close-out activities.
• Team Coordination and Communication:
  Coordinate research/project team meetings, ensuring effective communication and collaboration among team members.
• Specimen Management:
  Collect, process, and ship laboratory specimens following study protocols and regulatory requirements.
• Patient Management:
  Schedule subject visits and procedures, ensuring participants’ compliance with the study schedule. Conduct recruitment, pre-screening, screening, baseline enrollment, and follow-up visits with a participant-centered approach.
• Inventory and Records Management:
  Manage inventory and maintain accountability logs for investigational products, devices, and study-related supplies. Retain records and archive documents after study close-out, following regulatory guidelines and best practices.
• Phlebotomy and Clinical Procedures:
  Requires Phlebotomy certification, indicating the ability to perform blood draws and other specimen collection as part of the study procedures.

• Effective Writing and Communication:
  Clear and concise documentation and excellent interpersonal communication with study participants, team members, and regulatory bodies.
• Teamwork:
  Ability to work collaboratively within a research team and support team dynamics.
• Multitasking:
  Proficiency in managing multiple tasks and priorities with attention to detail and accuracy.
• Regulatory Knowledge:
  In-depth understanding of clinical trial regulations, ethical guidelines, and compliance standards, with ability to apply them practically.
• Organizational
  
  Skills:
  
  Strong organizational and project management skills to oversee study activities and ensure protocol compliance.

The following qualifications describe the typical background for a Clinical Research Coordinator 1 (CRC
1).

• Educational Background
  • Bachelor’s Degree in life sciences, nursing, public health, or related field (often minimum).
  • Master’s Degree in a relevant field (e.g., clinical research, biostatistics, epidemiology, healthcare management) may be preferred or enable entry with less practical experience.
• Professional Experience
  • For Bachelor’s Degree holders: typically 1–2 years of relevant clinical research experience.
  • For Master’s Degree holders: no practical experience required, but internships or exposure during studies are advantageous.
• Skills
  • Regulatory Knowledge:
    Understanding of GCP, HIPAA, IRB processes.
  • Data Management
    
    Skills:
    
    Proficiency with data management software and databases.
  • Communication
    
    Skills:
    
    Strong verbal and written communication for participants, team members, regulatory bodies, and sponsors.
  • Organizational and Multitasking Abilities:
    Ability to manage multiple study activities and maintain detailed records.
• Personal Attributes
  • Attention to Detail, Problem-Solving, Adaptability, and Teamwork.
• Additional Considerations
  • Experience with specific populations or therapeutic areas may be preferred.
  • Technology Proficiency:
    Familiarity with EHR, EDC, and other clinical research technologies.

These qualifications ensure a CRC is equipped to handle the complexities of clinical trials and uphold ethical and scientific integrity.

IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!