The posting
Clinical Research Coordinator II Lake Michigan Nephrology | St. Joseph, MI Lake Michigan Nephrology is seeking an experienced Clinical Research Coordinator II (CRC II) to lead clinical research activities at our St. Joseph, Michigan site. This role is responsible for supporting the successful execution of clinical trials from recruitment and enrollment through study completion while ensuring patient safety, data quality, protocol compliance, and adherence to Good Clinical Practice (GCP). The CRC II will work closely with Principal Investigators, physicians, clinic staff, patients, sponsors, and centralized research teams to build effective recruitment and enrollment workflows and ensure high-quality study execution. This is an excellent opportunity for a research professional who enjoys working directly with patients and providers and wants to make an impact within a growing nephrology research program. What You’ll Do
Lead day-to-day clinical research activities at the site level across assigned clinical trials. Read, understand, and implement study protocols, including eligibility criteria, visit schedules, procedures, and data collection requirements. Prescreen patients and proactively identify potential research participants through collaboration with physicians and clinic staff. Develop and implement effective workflows to support patient recruitment, referral, informed consent, enrollment, and retention. Partner with the Central Enrollment Team and other research departments to achieve referral, consent, and enrollment goals. Obtain and document informed consent in accordance with ICH/GCP, protocol requirements, and site SOPs. Train site staff on study objectives, procedures, and requirements and maintain appropriate training documentation. Evaluate site resources and coordinate with clinic leadership to ensure appropriate space, equipment, supplies, and staffing are available. Coordinate and conduct protocol-specific patient visits while maintaining compliance with visit windows and study requirements. Perform clinical procedures including vital signs, height/weight measurements, blood collection, specimen processing, and ECGs as required by protocol. Collect, process, and ship laboratory specimens according to protocol and applicable requirements. Dispense, collect, and maintain accurate accountability records for investigational products/study medications when applicable. Complete case report forms (CRFs), patient tracking tools, and other study documentation accurately and within required timelines. Maintain organized and audit-ready source documentation and study files. Prepare for monitoring visits by ensuring source documents, logs, accountability records, and other required materials are current and readily available. Respond promptly to monitor findings and ensure outstanding items and queries are appropriately resolved. Report Adverse Events and Serious Adverse Events to the appropriate IRB, sponsor, and management in accordance with reporting requirements. Maintain accurate, timely, and high-quality data in accordance with ALCOA principles. Maintain a thorough understanding of study-specific data collection instruments and ensure data is collected according to protocol. Support compliance with GCP, IATA, FDA regulations, institutional SOPs, and study-specific requirements. Manage multiple studies and a high volume of research patients while maintaining attention to detail and patient safety. Perform other duties and responsibilities as assigned.
What We’re Looking For
3–5+ years of clinical research experience Bachelor’s degree in a health-related field preferred. Medical Assistant (MA) certification preferred. GCP and/or IATA certification preferred. ACRP or SOCRA certification preferred. Bilingual English/Spanish skills preferred. Experience in CKD, nephrology, vascular access, or a related therapeutic area is a plus. Strong knowledge of medical terminology and clinical research practices. Hands-on experience with basic clinical procedures, including blood draws, vital signs, height/weight, and ECGs. Strong understanding of Good Clinical Practice (GCP) and applicable FDA and IATA requirements. Excellent interpersonal and communication skills with the ability to work effectively with patients, physicians, clinic staff, sponsors, and research teams. Highly organized, self-motivated, and detail-oriented with the ability to independently drive study activities and enrollment goals. Ability to manage competing priorities and multiple clinical trials in a fast-paced environment. Strong commitment to patient safety, data integrity, protocol compliance, and timely study execution. Flexibility to work a schedule that supports patient visits and study requirements.
Why Join Lake Michigan Nephrology? At Lake Michigan Nephrology, you’ll have the opportunity to contribute to clinical research that advances treatment options and improves care for patients living with kidney disease. As a site-level research leader, you’ll have meaningful interaction with patients and providers while playing a key role in the successful delivery of clinical trials.
