Clinical Research Coordinator

Company Overview

Unique opportunity to make an impact in the healthcare industry. Revival Research Institute, LLC was established in 2015, headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, Nebraska and North Carolina. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials.

• Regulatory Document Management:
  Manage essential regulatory documents, including Institutional Review Board (IRB) submissions and safety reports, ensuring compliance with all regulatory authorities 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 the integrity and timeliness of trial data. 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, and monitoring visits, as well as 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, maintaining 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:
  Capable of clear and concise documentation, and excellent interpersonal communication skills for interactions with study participants, team members, and regulatory bodies.
• Teamwork:
  Ability to work collaboratively within a research team, contributing positively to team dynamics and supporting team members.
• Multitasking:
  Proficiency in managing multiple tasks and priorities efficiently, adapting to changing demands with attention to detail and accuracy.
• Regulatory Knowledge:
  In-depth understanding of clinical trial regulations, ethical guidelines, and compliance standards, with the ability to apply these in practical settings.
• Organizational
  
  Skills:
  
  Strong organizational and project management skills to oversee study activities, manage documentation, and ensure compliance with study protocols.

Educational Background
Bachelor's Degree: A bachelor's degree in life sciences, nursing, public health, or a related field is often the minimum educational requirement. Master’s Degree: A master’s degree in a relevant field (such as clinical research, biostatistics, epidemiology, or healthcare management) may be preferred or allow candidates to enter the role with less practical experience.

• For Bachelor's Degree Holders:
  Typically 1-2 years of relevant experience in clinical research or a closely related field is preferred. This experience should demonstrate familiarity with clinical trial processes, regulatory compliance, patient interaction, and data management.
• For Master’s Degree Holders:
  No practical experience is necessary, but any internships, training, or exposure to clinical research during academic studies will be advantageous.

• Regulatory Knowledge: A thorough understanding of regulatory requirements and guidelines governing…