US Renal Care
SUMMARY
The
Clinical Research Specialist
(CRS) plays a pivotal role in managing daily clinical trial operations. In partnership with the principal investigator (PI) and their physician practice, the CRS ensures compliance with study protocols, federal regulations, and ethical standards while prioritizing the rights and well-being of study participants. Key Responsibilities: Coordinate comprehensive participant care from initial screening to trial completion, adhering to protocol and PI guidelines. Oversee the informed consent process, ensuring it meets regulatory standards. Maintain accurate source records for each study participant, documenting medical history, eligibility, and study-related procedures. Promptly report adverse events and protocol deviations to the PI, Sponsor, and IRB, as required. Educate participants on study processes, including informed consent and investigational product (IP) use. Facilitate timely communication of participant information among the research team. Uphold HIPAA regulations to protect participant confidentiality. Administer and guide participants on investigational product use per protocol. Collaborate with clinical teams, ensuring compliance with trial protocols. Collect and document trial data accurately in databases and Case Report Forms (CRFs). Assist with storage and management of research records in compliance with contractual requirements. Prepare for meetings such as site initiation and monitoring visits. Maintain Essential Documents for trial compliance and evaluation. Support recruitment efforts and target enrollment goals in collaboration with internal and external resources. Foster a culture focused on patient safety and high-quality care. Manage the patient stipend process effectively. Adhere to quality assurance program guidelines. Engage in travel for Investigator Meetings or relevant research activities. Develop knowledge of clinical research best practices and regulatory requirements. Provide training and mentorship to junior research staff as needed. Promote excellent customer service standards and build strong organizational relationships. Participate actively in team-based initiatives and meetings. Maintain regular attendance as required. Qualifications: Bachelor's degree in a related field is preferred. One to three years of experience in clinical research is required; nephrology experience is a plus. Familiarity with FDA regulations and Good Clinical Practice is essential. Knowledge of kidney care or End-Stage Kidney Disease (ESKD) is beneficial. Strong verbal and written communication skills are essential. Intermediate computer proficiency, including Microsoft Office and web-based tools; proficiency in company applications expected within 90 days of hire. Join our dedicated team and contribute to advancing medical research!
Clinical Research Specialist
(CRS) plays a pivotal role in managing daily clinical trial operations. In partnership with the principal investigator (PI) and their physician practice, the CRS ensures compliance with study protocols, federal regulations, and ethical standards while prioritizing the rights and well-being of study participants. Key Responsibilities: Coordinate comprehensive participant care from initial screening to trial completion, adhering to protocol and PI guidelines. Oversee the informed consent process, ensuring it meets regulatory standards. Maintain accurate source records for each study participant, documenting medical history, eligibility, and study-related procedures. Promptly report adverse events and protocol deviations to the PI, Sponsor, and IRB, as required. Educate participants on study processes, including informed consent and investigational product (IP) use. Facilitate timely communication of participant information among the research team. Uphold HIPAA regulations to protect participant confidentiality. Administer and guide participants on investigational product use per protocol. Collaborate with clinical teams, ensuring compliance with trial protocols. Collect and document trial data accurately in databases and Case Report Forms (CRFs). Assist with storage and management of research records in compliance with contractual requirements. Prepare for meetings such as site initiation and monitoring visits. Maintain Essential Documents for trial compliance and evaluation. Support recruitment efforts and target enrollment goals in collaboration with internal and external resources. Foster a culture focused on patient safety and high-quality care. Manage the patient stipend process effectively. Adhere to quality assurance program guidelines. Engage in travel for Investigator Meetings or relevant research activities. Develop knowledge of clinical research best practices and regulatory requirements. Provide training and mentorship to junior research staff as needed. Promote excellent customer service standards and build strong organizational relationships. Participate actively in team-based initiatives and meetings. Maintain regular attendance as required. Qualifications: Bachelor's degree in a related field is preferred. One to three years of experience in clinical research is required; nephrology experience is a plus. Familiarity with FDA regulations and Good Clinical Practice is essential. Knowledge of kidney care or End-Stage Kidney Disease (ESKD) is beneficial. Strong verbal and written communication skills are essential. Intermediate computer proficiency, including Microsoft Office and web-based tools; proficiency in company applications expected within 90 days of hire. Join our dedicated team and contribute to advancing medical research!