Revival Research Institute, LLC
Clinical Research Coordinator - Rheumatology
Revival Research Institute, LLC, Sterling Heights, Michigan, United States, 48310
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 grown to a national presence in the Metro-Detroit Region, Texas, Illinois, Nebraska, and North Carolina. Revival is nationally acknowledged for providing high-quality data for clinical research trials. Revival is growing and seeking qualified professionals who are looking for opportunities to grow and learn with us. The role of Clinical Research Coordinator (CRC) 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 certifications, knowledge of clinical trial processes, regulatory compliance, and practical skills in managing both operational and administrative aspects of clinical studies. 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. Data Integrity: 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 protocols and regulatory requirements. Patient Management: Schedule subject visits and procedures, ensure 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. Phlebotomy and Clinical Procedures: Requires Phlebotomy certification to perform blood draws and other specimen collection as part of study procedures. Required Skills and Abilities: Effective Writing and Communication: Clear documentation and excellent interpersonal communication with study participants, team members, and regulatory bodies. Teamwork: Ability to work collaboratively within a research team. Multitasking: Manage multiple tasks and priorities efficiently with attention to detail and accuracy. Regulatory Knowledge: Understanding of clinical trial regulations, ethical guidelines, and compliance standards. Organizational Skills: Strong organizational and project management skills to oversee study activities and ensure protocol compliance. Preferred Qualifications The preferred qualifications for a Clinical Research Coordinator (CRC 1) typically encompass a blend of education, experience, and skills to effectively manage and coordinate clinical research studies. Educational Background Bachelor’s Degree in life sciences, nursing, public health, or related field as a minimum educational requirement. Master’s Degree in a relevant field (e.g., clinical research, biostatistics, epidemiology, or healthcare management) may be preferred or allow entry with less practical experience. Professional Experience For bachelor’s degree holders: typically 1–2 years of relevant experience in clinical research or related field. For master’s degree holders: no practical experience required, but internships, training, or exposure are advantageous. Skills Regulatory Knowledge: Understanding of GCP, HIPAA, IRB processes. Data Management: Proficiency with data management software, accurate data entry, databases, and query resolution. Communication: Strong verbal and written communication with participants, team, regulatory bodies, and sponsors. Organizational and Multitasking Abilities: Manage multiple tasks and coordinate study activities with detailed records. Personal Attributes Attention to Detail Problem-Solving Skills Adaptability Teamwork Additional Considerations Experience with specific populations or therapeutic areas may be preferred depending on trials. Technology Proficiency: Familiarity with EHR, EDC systems, and other clinical research technologies. These qualifications ensure that a CRC is well-equipped to handle the complexities of clinical trials, contribute to research objectives, and uphold ethical and scientific integrity. IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!
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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 grown to a national presence in the Metro-Detroit Region, Texas, Illinois, Nebraska, and North Carolina. Revival is nationally acknowledged for providing high-quality data for clinical research trials. Revival is growing and seeking qualified professionals who are looking for opportunities to grow and learn with us. The role of Clinical Research Coordinator (CRC) 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 certifications, knowledge of clinical trial processes, regulatory compliance, and practical skills in managing both operational and administrative aspects of clinical studies. 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. Data Integrity: 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 protocols and regulatory requirements. Patient Management: Schedule subject visits and procedures, ensure 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. Phlebotomy and Clinical Procedures: Requires Phlebotomy certification to perform blood draws and other specimen collection as part of study procedures. Required Skills and Abilities: Effective Writing and Communication: Clear documentation and excellent interpersonal communication with study participants, team members, and regulatory bodies. Teamwork: Ability to work collaboratively within a research team. Multitasking: Manage multiple tasks and priorities efficiently with attention to detail and accuracy. Regulatory Knowledge: Understanding of clinical trial regulations, ethical guidelines, and compliance standards. Organizational Skills: Strong organizational and project management skills to oversee study activities and ensure protocol compliance. Preferred Qualifications The preferred qualifications for a Clinical Research Coordinator (CRC 1) typically encompass a blend of education, experience, and skills to effectively manage and coordinate clinical research studies. Educational Background Bachelor’s Degree in life sciences, nursing, public health, or related field as a minimum educational requirement. Master’s Degree in a relevant field (e.g., clinical research, biostatistics, epidemiology, or healthcare management) may be preferred or allow entry with less practical experience. Professional Experience For bachelor’s degree holders: typically 1–2 years of relevant experience in clinical research or related field. For master’s degree holders: no practical experience required, but internships, training, or exposure are advantageous. Skills Regulatory Knowledge: Understanding of GCP, HIPAA, IRB processes. Data Management: Proficiency with data management software, accurate data entry, databases, and query resolution. Communication: Strong verbal and written communication with participants, team, regulatory bodies, and sponsors. Organizational and Multitasking Abilities: Manage multiple tasks and coordinate study activities with detailed records. Personal Attributes Attention to Detail Problem-Solving Skills Adaptability Teamwork Additional Considerations Experience with specific populations or therapeutic areas may be preferred depending on trials. Technology Proficiency: Familiarity with EHR, EDC systems, and other clinical research technologies. These qualifications ensure that a CRC is well-equipped to handle the complexities of clinical trials, contribute to research objectives, and uphold ethical and scientific integrity. IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!
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