Clinical Research Coordinator II

Clinical Research Coordinator II Position Title: CLINICAL RESEARCH COORDINATOR II Position Number: 8150021, Work Modality: Hybrid – 4 In-Person, Job Category: University Staff, Job Type: Full-Time, FLSA Status: Non-Exempt, Campus: Maywood-Health Sciences Campus, Department Name: HEMATOLOGY ONCOLOGY, Location Code: HEMATOLOGY - ONCOLOGY (06508A). Duties and Responsibilities The Clinical Research Coordinator II is responsible for the overall management and implementation of an assigned set of multiple research protocols assuring efficiency and regulatory compliance. Assists in the preparation of initial study documents for IRB submission in compliance with all local, state and federal regulations; advises the IRB of amendment changes to the protocol and completes annual protocol renewals. Recruits, screens, assists in the informed consent process and enrolls subjects in accordance with good clinical practice guidelines. Collects, records and maintains complete data files using good clinical practice and HIPAA regulations. Participates in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies. Interacts with subjects by scheduling diagnostic and research evaluation visits, performing study related assessments including collection of blood samples, processing and shipment. Maintains drug accountability, adequate study supplies and equipment. Oversees subject compliance to the study protocol, obtains information from the study subject regarding any changes in their medications or adverse events and promptly reports findings to physicians for documentation in the subject’s medical record. Reports all serious adverse events promptly to investigators, sponsors and the IRB. Protects the rights, safety and well-being of human subjects involved in the clinical trials. Coordination Responsibilities Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines. Serves as primary contact with research participants, sponsors, and regulatory agencies. Coordinates studies from startup through close-out. In collaboration with the PI & RN, incorporates clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria. Coordinates collection of study specimens and processing. Collects and manages patient and laboratory data for clinical research projects. Manages research project databases, develops flow sheets and other study related documents, and completes study documents/case report forms. Ensures compliance with research protocols, and reviews and audits case report forms for completion and accuracy with source documents. Prepares regulatory submissions and ensures institutional Review Board renewals are completed. Assembles study kits for study visits, monitors scheduling of procedures and charges, coordinates documents, and attends monitoring meetings with sponsors, acting as primary contact. Ensures adherence to study budgets and resolves billing issues in collaboration with finance and/or management staff. Interacts with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. Ensures essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. Participates in monitor visits and regulatory audits. Regulatory Responsibilities Processes local IRB submissions to include new research projects, amendments, adverse events and study terminations. Minimum Education and/or Work Experience Bachelor’s Degree OR equivalent training acquired via work experience or education. 2-5 years of previous job-related experience. Qualifications Ability to follow oral and written instructions and established procedures. May require use of centrifuge, make slides for labs, ECG’s to be performed and transmitted. Medication administration. Certificates/Credentials/Licenses SOCRA CCRP or ACRP certification OR equivalent CRO industry experience with certification obtained within 1 year of hire. Computer Skills Basic knowledge in Excel, WORD, EPIC (EMR for the hospital), and Internet based data submission. Training and Other Requirements Physical demands: Repetitive Motions. No direct animal or patient contact. No operation of university owned vehicles. Salary Position Maximum Salary or Hourly Rate: $31/hr. Position Minimum Salary or Hourly Rate: $27/hr. Special Instructions to Applicants As a Jesuit, Catholic institution of higher education, we seek candidates who will contribute to our strategic plan to deliver a Transformative Education in the Jesuit tradition. To learn more about Loyola University Chicago’s mission, candidates should consult our website at . For information about the university’s focus on transformative education, they should consult our website at . About Loyola University Chicago Founded in 1870, Loyola University Chicago is one of the nation’s largest Jesuit, Catholic universities, recognized for its academic excellence, commitment to community engagement, and leadership in sustainability. A Carnegie R1 research institution, Loyola leverages its status as one of an elite group of universities with the highest level of research activity to advance knowledge that serves communities and creates global impact. With 15 schools, colleges, and institutes—including Business, Law, Medicine, Nursing, and Health Sciences—Loyola operates three primary campuses in the greater Chicago area and one in Rome, Italy, that provide students a transformative, globally connected learning experience. Consistently ranked among the nation’s top universities by U.S. News & World Report, Loyola is a STARS Gold-rated institution that is ranked as one of the country’s most sustainable campuses by The Princeton Review and has earned distinctions from AmeriCorps and the Carnegie Foundation for its longstanding record of service and community engagement. Guided by its Jesuit mission and commitment to caring for the whole person, Loyola educates ethical leaders who think critically, act with purpose, and strive to create a more just and sustainable world. Benefits Loyola University Chicago offers its staff and faculty a wide array of affordable, comprehensive, and competitive benefits. EEO Statement Loyola adheres to all applicable federal, state, and/or local civil rights laws and regulations prohibiting discrimination in private institutions of higher education. Please see the University’s Nondiscrimination Policy. Applicant Documents Resume Cover Letter/Letter of Application Contact Information 1032 W Sheridan Rd | Chicago, IL 60660 | View phone number on click.appcast.io Supplemental Questions Do you have a Bachelors Degree OR equivalent training acquired via work experience or education? Yes No Why do you want to work for Loyola University Chicago? (Open Ended Question) How do your values align with Loyola University Chicago's mission and values? (Open Ended Question) How did you hear about this employment opportunity? Public Job Posting Internal Job Posting Agency Referralnius]. Advertisement/Publication Personal Referral Website Other #J-18808-Ljbffr LRES Corporation