Clinical Research Coordinator - Rheumatology

Job Description

Job Description

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, and has been growing ever since. Revival now has a national presence in the  Metro-Detroit Region, Texas, Illinois, Nebraska, & North Carolina.  We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials.

As  Revival Research Institute  is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us.

The role of Clinical Research Coordinator builds upon the foundational responsibilities of an Assistant Clinical Research Coordinator, expanding into more autonomous management of clinical research activities with moderate supervision. This role requires a blend of specific certifications, detailed knowledge of clinical trial processes, regulatory compliance, and practical skills in managing both the operational and administrative aspects of clinical studies. Here’s a detailed overview of the responsibilities and skills required for a CRC :

Core Responsibilities :

• 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 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.

Required Skills and Abilities :

Preferred Qualifications :

The preferred qualifications for a Clinical Research Coordinator 1 (CRC 1) typically encompass a blend of educational achievements, practical experience, and specialized skills that equip the individual to effectively manage and coordinate clinical research studies. Here is a detailed outline of these qualifications :

Educational Background

Professional Experience

Skills

Personal Attributes

Additional Considerations

These qualifications ensure that a CRC is well-equipped to handle the complexities of clinical trials, contribute effectively to research objectives, and uphold the highest standards of ethical and scientific integrity.

IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!

Powered by JazzHR

OflEhHws2m