New

Clinical Research Coordinator III

Loyola University Chicago

403(b)

United States, Illinois, Chicago

820 Michigan Avenue (Show on map)

Jan 17, 2025

Position Details

Job Title	CLINICAL RESEARCH COORDINATOR III
Position Number	8150821
Job Category	University Staff
Job Type	Full-Time
FLSA Status	Non-Exempt
Campus
Department Name
Location Code	CLINICAL RESEARCH OFFICE (06124A)
Is this split and/or fully grant funded?	Yes
Duties and 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. Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. Coordinate collection of Study specimens and processing. Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other Study related documents, and complete Study documents/case report forms. Assemble Study kits for Study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Participate in monitor visits and regulatory audits. Regulatory responsibilities: Establish and maintain research project's regulatory files Ongoing communication with the local IRB, federal organizations, affiliate institutions and pharmaceutical Study sponsors. Processes local IRB submissions to include new research projects, amendments, adverse events and Study terminations. Oversee subject recruitment and Study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data. Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes. Train, and/or mentor new staff or students Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions. Collaborate with Principal Investigators and Study Sponsors, monitor and report serious adverse events, and resolve Study queries. Administers the investigational product according to the parameters of the Study protocol and under the direction of the physician. Conducts ongoing assessments of the overall Study execution within the facility/practice, communicating concerns to the Director, PI, Study Sponsor or IRB as needed. Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices. Develop Study budget with Staff and Principal Investigator, identifying standard of care versus Study procedures. Track patient and Study specific milestones, and invoice sponsors according to Study contract. Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance. Work with Principal Investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. Data Management Responsibilities: Collects, records and maintains accurate data reporting adhering to protocol data collection protocol and federal guidelines. Clarifies Data Queries. Specimen Handling and Shipping Responsibilities: Coordinates with the Clinical Research RN to organize procurement of research samples and then prepares, packages and ships research samples. Manages research sample supplies. Participates in Cooperative Group Audits, FDA, Sponsor GCP quality audits, Loyola internal audits and department audits. 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. Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate 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. Coordinate collection of Study specimens and processing. Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other Study related documents, and complete Study documents/case report forms. Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed. Assemble Study kits for Study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Ensure adherence to Study budgets and resolve billing issues in collaboration with finance and/or management staff. Interact with the principal investigator regularly, ensuring patient safety and adherence to proper Study conduct. Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. Participate in monitor visits and regulatory audits. Performs other duties as assigned.
Minimum Education and/or Work Experience	Performs a wide range of tasks associated with conducting clinical trials and research studies while managing multiple research protocols and procedures.
Qualifications	SOCRA CCRP or ACRP certification OR equivalent CRO industry experience with certification obtained within 1 year of hire.
Certificates/Credentials/Licenses	SOCRA CCRP or ACRP certification OR equivalent CRO industry experience with certification obtained within 1 year of hire.
Computer Skills	Basic computer skills
Supervisory Responsibilities	No
Required operation of university owned vehicles	No
Does this position require direct animal or patient contact?	No
Physical Demands	None
Working Conditions	None
Open Date	01/16/2025
Close Date
Position Maximum Salary or Hourly Rate	$31.25/hr
Position Minimum Salary or Hourly Rate	$28.85/hr
Special Instructions to Applicants
About Loyola University Chicago	Loyola University Chicago is a private Jesuit University founded in 1870 by the Society of Jesus. One of the largest Catholic Universities in the United States, Loyola's professional schools include programs in medicine, nursing, and health sciences anchored by the Loyola University Medical Center, and the Loyola University Chicago School of Law. Comprised of thirteen colleges and schools, Loyola University Chicago offers more than 80 undergraduate and 140 graduate/professional programs while enrolling approximately 17,000 students. In addition to offering a world class educational experience, Loyola University Chicago strives to be an employer of choice by offering its staff and faculty a wide array of affordable, comprehensive, and competitive benefits. Our benefits are centered on health and wellness, financial security, equity, and work-life balance. We offer medical, dental, vision, 403(b), HSA, FSAs, tuition benefit, pre-tax transit benefits, EAP, and more. To view our benefits in detail, click here. As one of the nation's largest Jesuit, Catholic Universities, Loyola University Chicago fosters a transformative cultural experience that honors Diversity, Equity, and Inclusion. We are committed to recruiting and retaining a diverse, mission driven workforce that enables a culture of inclusivity. We act with the heart of a nonprofit organization and an academic enterprise with ethical practices that advance the Jesuit Mission. Loyola actively seeks to build a community of diverse opinions, perspectives, and backgrounds that support our Jesuit tradition, while helping Ramblers foster a sense of belonging and affinity for all. Loyola University Chicago is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion (except where religion is a bona fide occupational qualification for the job), national origin, sex, age, disability, marital status, sexual orientation, gender identity, protected veteran status or any other factor protected by law.
Quick Link for Posting	https://www.careers.luc.edu/postings/30741