Clinical Research Navigator, RN

Description: Join Our Team: Clinical Research Navigator, RN Location: Michigan Institute of Urology – 130 Town Center Drive, Troy, MI Schedule: Full-Time | Monday – Friday (40 Hours/Week) | Day Shift About the Role Are you a dedicated Registered Nurse with a passion for clinical research, precision, and patient-centered care? Michigan Institute of Urology (MIU) is seeking an experienced, detail-oriented Clinical Research Navigator, RN to join our clinical trials team in Troy, MI. In this pivotal role, you will bridge the gap between advanced urological research and compassionate patient care. You will oversee clinical trial execution from protocol adherence and participant recruitment to electronic data capture and direct patient coordination. Key Responsibilities Patient Navigation & Care: Guide research participants through trial protocols, answer questions, schedule visits, and deliver compassionate nursing care during study appointments. Clinical Trial Execution: Coordinate patient procedures, conduct medical assessments, collect and package biological specimens, and administer investigational products strictly per study protocol. Meticulous Data & Compliance Management: Maintain impeccable documentation, perform source data entry in EDC systems (CRIO), resolve queries, and conduct quality assurance audits to ensure adherence to GCP, FDA, and local regulations. Study Operations: Oversee protocol amendments, manage IP inventory, stock study supplies, and collaborate with sponsors, principal investigators, and clinical trial monitors. Candidate Qualifications Required RN Licensure: Active, unencumbered Registered Nurse (RN) license in the State of Michigan. Certifications: Current Basic Life Support (BLS) certification. Education: Graduate of an accredited school of nursing; Bachelor’s degree required. Experience: 2+ years of prior experience in clinical research or clinical trial coordination strongly preferred. Key Skills: Exceptional attention to detail, strong analytical capabilities, superior organizational skills, and outstanding interpersonal communication skills. Preferred Advanced Cardiovascular Life Support (ACLS) certification. Master’s degree in a related scientific field (Biology, Pharmacology, Biochemistry, or MSN). Familiarity with EPIC EHR software and CRIO trial management platform. Active GCP (Good Clinical Practice) and IATA biological shipping certifications. Why Choose Michigan Institute of Urology? Balanced Schedule: Enjoy a consistent Monday–Friday, 40-hour work week with no weekend or night shifts. Impactful Work: Be at the forefront of cutting-edge urological research and contribute directly to innovative treatments. Collaborative Environment: Work alongside leading urology specialists in a supportive, team-focused clinical setting. How to Apply Ready to advance your nursing career in clinical research? Apply online today with your updated resume and cover letter detailing your clinical research experience. GENERAL SUMMARY The Clinical Research Navigator, RN is responsible for coordinating and overseeing the execution of studies and clinical trials. They have a hand in everything from recruiting study participants to creating study documentation, collecting patient data, and performing quality assurance audits to ensure study protocols are being followed Requirements: ESSENTIAL JOB FUNCTION/COMPETENCIES Responsibilities include but are not limited to: Recruit and enroll study participants. Input clinical research data into electronic data systems. Coordinate patient visits and procedures related to research. Act as resource for study participants by answering questions and explaining related procedures. Ensure the study site is compliance with all local and federal laws and regulations. Monitor study sites and activities to ensure the the appropriate industry protocols and terms of the study are being followed. Oversee the hiring and training of staff members who are working on the study. Create thorough documentation of study protocol and update it as needed. Provide subject care and data collection procedures in adherence with the assigned study protocol and in accordance with good clinical research principals. Review subject charts, database records, and other sources to screen and identify potential subjects for inclusion in study based on criteria described in the protocol. Coordination and management of the clinical trial, communication with sponsor and authorities, visit coordination, sampling, time management and product accountability. Data collection and management, collection and development of source documents, use of CRFs, managing patient registration, AEs, filing and archiving, managing monitoring visits, dealing with queries. Maintain accurate records of the receipt, inventory, and dispensation of study drug and obtain and coordinate subject blood samples, cultures, tissues, and other specimens for laboratory analysis as described in study protocol. Patient visits, data collection and transcription/EDC, prepare for monitor visits, protocol adherence to include height, weight, blood pressure, respirations, pulse temperature, O2 saturation. Schedule appointments and organize materials to be used during study visits and ensure that all required tests are completed for each study visit per protocol. Includes initial study start-up information/ requirements, dissemination of updated Investigator’s Brochures, protocols and informed consent information, online training initiated by sponsor, review of correspondence throughout study. Completes Source Documentation-which includes completing and uploading all necessary documents to CRIO and maintaining all charts properly. Medical Assessment-includes obtaining information from patient or chart regarding name of medication, start and stop dates, dose, and indication. Biological Sampling Collection/Packaging/Shipping – includes serum and/or tissue collection, processing, packaging and shipping per study specific requirements. Case Report Form (CRF) Entries and Management – includes data entry, query resolution in paper and/or electronic CRFs. Investigational Product (IP) Management – includes receiving IP supplies, IP accountability, monitoring of temperature controls, destructions or return of IP. Develop and/or Maintain Essential Documents – includes study specific training documents, study specific logs, patient questionnaires, patient pill diaries, lab requisition forms, other study specific forms. Supply Chain Maintenance-Supplies Inventoried, stocking, organizing, and resupply order placed as required. Completed in Envi system. Study Coordination- rooming, administer questionnaires, scheduling scans, set up room for procedures and wipe and clean equipment after procedures and visits. Obtain/Maintain all required training- GCP, IATA,CPR Occasionally help the study coordinators at other offices such as the surgery center. Performs other position related duties as assigned. Employees shall adhere to high standards of ethical conduct and will comply with and assist in complying with all applicable laws and regulations. This will include and not be limited to following the Solaris Health Code of Conduct and all Solaris Health and Affiliated Practice policies and procedures; maintaining the confidentiality of patients' protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA); immediately reporting any suspected concerns and/or violations to a supervisor and/or the Compliance Department; and the timely completion the Annual Compliance Training. CERTIFICATIONS, LICENSURES OR REGISTRY REQUIREMENTS BLS certification required, ACLS preferred. RN licensure. License and certification as required by state. KNOWLEDGE | SKILLS | ABILITIES Must possess superior analytical and creative thinking skills. Excellent attention to detail and the ability to keep detailed, accurate records. Understanding of laboratory procedures and equipment. Knowledge of medical terminology, healthcare coding systems, and clinics functions. Must be able to function in a team-oriented environment, display strong analytical, investigative, interpersonal and organizational skills, pay high attention to detail with consistent follow-through and be able to productively manage high volumes of work. Knowledge of database management. Maintain a working knowledge of all assigned study protocols and amendments. Excellent verbal and written communication skills. Skill in using computer programs and applications including Microsoft Office. Delivers exceptional patient service throughout all interactions. Excellent organizational skills and attention to detail. Strong analytical and problem-solving skills. Complies with all health and safety policies of the organization. Complies with HIPAA regulations for patient confidentiality. Ability to work independently and manage deadlines. Ability to establish and maintain effective working relationships with patients, colleagues, physicians and the public; successfully manages interactions with challenging or difficult people. Ability to deal compassionately, professionally, and courteously with patients, their families, physicians, and staff. Ability to build relationships with patients and display empathy and compassion to patients. EDUCATION REQUIREMENTS Graduate of an accredited school of nursing required. Bachelor's degree required. Master's degree in a related field like biology, pharmacology or biochemistry preferred. EXPERIENCE REQUIREMENTS Experience with EPIC software preferred but not essential. 2+ years of prior clinical research experience, strongly preferred. REQUIRED TRAVEL Minimal travel required. PHYSICAL DEMANDS Carrying Weight Frequency 1-25 lbs. Frequent from 34% to 66% 26-50 lbs. Occasionally from 2% to 33% Pushing/Pulling Frequency 1-25 lbs. Seldom, up to 2% 100 + lbs. Seldom, up to 2% Lifting - Height, Weight Frequency Floor to Chest, 1 -25 lbs. Occasional: from 2% to 33% Floor to Chest, 26-50 lbs. Seldom: up to 2% Floor to Waist, 1-25 lbs. Occasional: from 2% to 33% Floor to Waist, 26-50 lbs. Seldom: up to 2%