clinical coordinator

assoc clinical research coord-19503 Jobs in Chicago

assoc clinical research coord-19503

clinical recruiter

clinical research assistant Jobs in Chicago

clinical research assistant

clinical research assistant - rush alzheimer’s disease center Jobs in Chicago

clinical research manager

The University of Chicago

<div>Department
BSD OCR - Clinical Research Operations 
About the Department
The Office of Clinical Research (OCR) is the nucleus of the clinical research enterprise, providing services, training, tools and compliance oversight to support the conduct of clinical research across the entire Biological Sciences Division and University of Chicago Medicine human subject research portfolio.The mission of the Office of Clinical Research is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers. Together, we elevate the human experience with knowledge and health care. 
Job Summary
The job manages a team of professional staff responsible for performing clinical research including the collection, documentation, analysis of clinical trial data, and reporting of clinical research data. Manages the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University. 
 
The Clinical Research Manager is part of the Research Incubation Unit of the Office of Clinical Research. The Clinical Research Incubation Unit was established to enable growth of clinical research portfolios across the Biological Sciences Division as well as provide timely research staffing services to departments or units in need of short-term clinical research management services. The Clinical Research Manager manages a team of professional staff responsible for clinical research conduct , research participant management, data management, and regulatory. Key responsibilities of the Manager include recruiting, onboarding, and training of new clinical research staff; day-to-day management and supervision of clinical research staff; supporting study initiation and completion of key milestones throughout the life cycle of the trials; tracking and reporting on key metrics; communicating with investigators and department leaders; communicating with industry sponsors and internal stakeholders; and fulfilling service level agreement performance standards. This position will have primary accountability to the Director of Clinical Research Operations within the Office of Clinical Research.
Responsibilities<ul><li>
Oversee Departmental Clinical Research Portfolio across the lifecycle for each protocol from feasibility, startup, recruitment, day-to-day conduct, follow up through study close out.</li><li>
Coordinate departmental clinical research staff and faculty meetings.</li><li>
Oversee the conduct of clinical research, regulatory compliance, and IRB filings for all projects in the departmental portfolio.</li><li>
Establish documentation standards for departmental scientific review and feasibility for all proposed clinical research projects.</li><li>
Establish departmental standard work and standard operating procedures.</li><li>
Monthly Reports of site performance and percent effort reports.</li><li>
Training and onboarding of all research staff in GCP, 21 CFR 11, 21 CFR 312, 21 CF 812 and divisional policies for the conduct of clinical research.</li><li>
Management and supervision for all Research Incubator clinical research staff.</li><li>
Establish professional relationships with Contract Research Organizations, Pharmaceutical Sponsors, Funders and Grantors.</li><li>
Collaboration with departmental, Research Incubator, and divisional stakeholders for clinical research.</li><li>
Works with leadership, advisory compliance committee members and research unit leaders to establish a culture of research compliance.</li><li>
Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners.</li><li>
Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.</li><li>
Manages PI and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as expert in specialized area. Ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities.</li><li>
Performs other related work as needed.</li></ul> 
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field. 
Work Experience:
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline. 
Certifications:
-
Preferred Qualifications
Education:<ul><li>
Master's Degree strongly preferred.</li></ul>
Experience:<ul><li>
Experience with both industry sponsored FDA regulated clinical trial and investigator initiated clinical trial site management.</li><li>
Regulatory support for FDA and IRB filings.</li><li>
Protocol development support experience.</li></ul>
Licenses and Certifications:<ul><li>
ACRP / SOCRA research certification.</li></ul>
Preferred Competencies<ul><li>
Mentors or trains others to communicate effectively with CRO and/or sponsor, and in managing and conducting site visits. Understands the relationship between sites, sponsors and CROs in order to solve problems.</li><li>
Creates and maintains departmental infrastructure for scientific review, feasibility assessment and projected effort/protocol.</li><li>
Determines and manages complex study and equipment resources for more than one study, and processes related to their management. Forecasts study needs, including staffing. Effectively solves complex problems related to managing resources.</li><li>
Ensure that multiple studies are conducted in compliance with institutional requirements and other policies. Mentor others in this area.</li><li>
Develops, follows, and implements detailed complex operational plans for research protocol(s) (those that require coordination of multiple units or services).</li><li>
Partnering with faculty set site performance metrics and targets: enrollment, retention, data quality, start-up timeline, Unanticipated Problem rate etc. and works with team to understand root cause of metric in non-conformance and take appropriate actions. Measures impact of preventive and corrective actions.</li><li>
For complicated scenarios, recognizes when all types of agreements (MTAs, CTAs, CDAs, DUAs, DTAs, etc.) are necessary and which procedures to follow, including special terms that may need to be included.</li><li>
Prepares and maintains FDA regulatory submissions on more than one PI-initiated study overseen by the FDA. Handles complex situations and/or potential hold issues directly with the FDA, in collaboration with the PI.</li><li>
Demonstrates advanced application and knowledge of monitoring and audits. Trains or leads others in most tasks related to monitoring and audits.</li><li>
Sets meeting objectives, goals and detailed agendas for multidisciplinary meetings. Mentors or trains others in meeting preparation and follow up. Facilitate healthy communication during meetings.</li><li>
Conduct and document informed consent for multiple interventional and/or complex studies. Exhibit additional knowledge or skills in consent procedures.</li><li>
Advanced understanding of sponsor/regulatory reporting.</li><li>
Independently develops, or guides the development, of multiple complex data entry or collection protocols and tools. Systems are developed to ensure quality of data. Trains others in collecting and entering data.</li></ul>
Working Conditions<ul><li>
Office Environment (ADA compliant).</li><li>
Clinical care units where research is conducted, and department lab space for specimen processing.</li></ul>
Application Documents<ul><li>
Resume (required)</li><li>
Cover Letter (preferred)</li></ul><div><div><div><div><div><div><div> 
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.</div></div></div></div></div></div></div> 
Job Family
Research 
Role Impact
People Manager 
Scheduled Weekly Hours
40 
Drug Test Required
No 
Health Screen Required
No 
Motor Vehicle Record Inquiry Required
No 
Pay Rate Type
Salary 
 
FLSA Status
Exempt 
 
Pay Range
$90,000.00 - $130,000.00
The included pay rate or range represents the University&rsquo;s good faith estimate of the possible compensation offer for this role at the time of posting. 
Benefits Eligible
Yes
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook. 
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination. 
Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form. 
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position. 
The University of Chicago's Annual Security &amp; Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.</div>

Clinical Research Manager, Research Incubation Unit

Rush University Medical Center

<div>Location: Chicago, Illinois
Business Unit: Rush Medical Center
Hospital: Rush University Medical Center
Department: Research Affairs-ResAdm
Work Type: Full Time (Total FTE between 0.9 and 1.0)
Shift: Shift 1
Work Schedule: 8 Hr (8:00:00 AM - 5:00:00 PM)
Rush offers exceptional rewards and benefits learn more at our Rush benefits page (https://www.rush.edu/rush-careers/employee-benefits).
Pay Range: $45.59 - $66.16 per hour
 
Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush&rsquo;s anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case.
Summary:
 
The Clinical Research Financial Manager is an integral part of the Rush University Sponsored Program Financial Management (SPFM) team in the Sponsor Program Office within the Office of Research Affairs (ORA). The Office of Research Affairs (ORA) serves as the institutional home for research administration and oversight, dedicated to promoting, facilitating, advocating for, and supporting all research activities conducted across Rush. The Clinical Research Financial Manager operates at the intersection of Sponsored Programs Financial Management and Clinical Research Administration. This role collaborates closely with team members across both divisions to ensure effective financial oversight, compliance, and support of clinical research activities. The Clinical Research Financial Manager is responsible for comprehensive financial management of industry funded, earnings-based studies. This includes payment tracking, reconciliation, and expense oversight for human subjects' research protocols. This role serves as the study team&rsquo;s primary point of contact for clinical research financial management, ensuring timely and accurate financial activity across multiple financial systems. Responsibilities include reconciliation and tracking of human subjects' research revenue and expenses, as well as the preparation and delivery of financial status reports to stakeholders as requested.
 
 
Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures 
 
<div>Other information:
 
Required Job Qualifications:
 
<ul><li>Bachelor&rsquo;s degree
</li><li>2-4 year experience in finance, healthcare, clinical research or a related field 
</li></ul> 
 
Knowledge, Skills, &amp; Ability:
 
<ul><li>Ability to handle high volume of work with changing priorities and constant interruptions and establish priorities and deadlines required
</li><li>Solution and service oriented with proven record trouble shooting complex and day-to-day challenges
</li><li>Demonstrated proficiency with word processing, spreadsheet, and database software (MS Office skills such as Outlook, Wod, Excel, PowerPoint, SharePoint)
</li><li>Ability to manage large and complex research portfolios.
</li><li>Strong organizational skills and attention to detail
</li><li>Strong interpersonal, verbal, and written communication skills are required.
</li><li>Exceptional attention to detail and ability to maintain confidential information required
</li><li>Ability to work successfully both independently and in team settings
</li><li>Excellent time management with ability to prioritize tasks as needed
</li><li>Willingness to learn new methodologies, tools and techniques
</li><li>Flexible work hours and travel may be required 
</li></ul> 
 
Preferred Job Qualifications:
 
<ul><li>Experience involving clinical trials, grant/research administration experience in a hospital, university or other research setting.
</li><li>Experience with clinical trial budgets, clinical trial financial management, clinical trial agreements, and/or clinical research regulatory management.
</li><li>Experience with OnCore, Epic and Workday.
</li><li>Previous experience with coordinating clinical trials. 
</li></ul> 
 
Physical Demands:
 
Competencies:
 
Disclaimer: The above is intended to describe the general content of and requirements for the performance of this job It is not to be construed as an exhaustive statement of duties, responsibilities or requirements 
 
</div><div>Responsibilities:
 
<ul><li>Read and interpret clinical trial study documents including protocol, budget, contract, informed consent, and laboratory manual.
</li><li>Monitor sponsor, regulatory and institutional compliance with contract terms and institutional policies and procedures.
</li><li>Performs financial account reconciliations, statement analysis, and transaction research.
</li><li>Supports the timely research account financial review and invoicing to sponsors which match protocol-driven procedures with patient accruals/visits to ensure appropriate invoicing and reimbursement.
</li><li>Records invoice entries and develop reports for tracking and auditing.
</li><li>Reconcile study payments received against study activities and invoices.
</li><li>Ability to collate data from multiple sources.
</li><li>Reviews and reconcile actual expenses to budget.
</li><li>Compare actual spending to the budget and evaluate variances and trends.
</li><li>Responsible for timely reconciliation and close-out of research accounts.
</li><li>Conducts activities to ensure that Rush University Systems for Health and the Investigator&rsquo;s financial accounts are reconciled for all contracted research-related services.
</li><li>Provide accurate and timely financial status reports, and create study dashboards for senior leaders, investigators, business managers and business partners, study teams, Principal Investigators, and business managers, if requested.
</li><li>Communicate clearly with researchers, administrators, and sponsors to support accurate and timely research financial management.
</li><li>Interact and communicate with key stakeholders and various funding agencies.
</li><li>Performs other related duties as assigned or requested. 
</li></ul></div>Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.</div>

Clinical Research Financial Manager- Full-time

Retinal Consultants

**Overview:** We are seeking a dedicated Study Manager to join our team. The ideal candidate will have experience in clinical trials management and possess strong knowledge of clinical development processes. **Responsibilities:** - Manage and oversee clinical trials from initiation to completion - Ensure compliance with HIPAA regulations and other relevant standards - Review and maintain accurate documentation throughout the study - Conduct vital signs assessments and phlebotomize when necessary - Collaborate with clinical laboratory staff to ensure accurate results - Implement compliance management strategies to uphold study integrity **Experience:** - Proven experience in clinical trials management - Familiarity with HIPAA regulations and compliance standards - Ability to review and interpret clinical trial documentation - Knowledge of phlebotomy techniques - Strong understanding of clinical development processes This position offers the opportunity to work in a dynamic environment where you can contribute to cutting-edge research initiatives. If you are passionate about clinical trials and ensuring high-quality study outcomes, we encourage you to apply.Job Type: Part-timePay: $20.00 - $25.00 per hourBenefits:<ul><li>Paid time off</li></ul>Work Location: In person

Ophthalmology Clinical Trial Coordinator

INSIGHT

<div></div><div><div>Job Title: Clinical Research Coordinator III &ndash; Team Lead 
Department: Clinical Research Operations 
Location: On-site (Insight Hospital &amp; Medical Center Chicago) 
Schedule: Full-time, Monday through Friday (8AM-5PM) &ndash;additional flexibility required to meet job requirements</div>
<div>Reports To: Director of Clinical Trials</div>
<div>Position Summary</div>
<div>The Clinical Research Coordinator III &ndash; Team Lead is a senior-level hybrid role responsible for leading the coordination of complex clinical trials while supervising and mentoring the on-site research team. This position functions as a &ldquo;player/coach,&rdquo; combining direct study coordination with oversight of Clinical Research Coordinators and Clinical Research Assistants. The CRC III &ndash; Team Lead ensures operational excellence, regulatory compliance, and a culture of accountability and continuous improvement.</div>
<div>This role also collaborates closely with the Patient Recruitment department to support enrollment success through candidate prescreening, outreach, and community engagement. In addition, the CRC III &ndash; Team Lead supports regulatory and quality functions directly with the team and in collaboration with centralized regulatory and quality resources.</div>
<div>Core Competencies</div>
<ul><li>Advanced knowledge of clinical trial operations, GCP, FDA regulations, and IRB processes</li>
<li>Strong leadership and coaching skills with a collaborative, solutions-oriented mindset</li>
<li>Excellent communication and interpersonal abilities across diverse stakeholders</li>
<li>High attention to detail, time management, and multitasking capabilities</li>
<li>Commitment to quality, compliance, and participant safety</li></ul> 
<div></div><div>Key Responsibilities</div>
<div>Study Leadership and Coordination</div>
<ul><li>Serve as lead coordinator on high-priority or complex trials, managing all phases from startup to closeout</li>
<li>Provide backup coverage and operational support for other coordinators during absences or escalations</li>
<li>Ensure protocol adherence, timely data entry, and accurate documentation across assigned studies</li>
</ul><div>Team Supervision and Mentorship</div>
<ul><li>Supervise and mentor Clinical Research Coordinators I and II and Clinical Research Assistants</li>
<li>Lead onboarding, training, and ongoing development for study staff</li>
<li>Conduct regular team huddles, protocol reviews, and best practice sessions</li>
</ul><div>Regulatory and Quality Support</div>
<ul><li>Support regulatory and quality functions directly with the team and in collaboration with centralized regulatory and quality resources</li>
<li>Ensure accurate completion, review, and submission of IRB documents, amendments, and safety reports</li>
<li>Maintain essential regulatory files and sponsor communications</li>
<li>Participate in internal audits, monitoring visits, and CAPA implementation</li>
</ul><div>Patient Recruitment and Engagement</div>
<ul><li>Partner with the Patient Recruitment department to develop and execute enrollment strategies</li>
<li>Conduct candidate prescreening and outreach activities to support recruitment goals</li>
<li>Participate in community engagement efforts to raise awareness and build trust with potential participants</li>
</ul><div>Operational Collaboration</div>
<ul><li>Serve as liaison between the research team, investigators, sponsors, and institutional departments</li>
<li>Assist in resource planning, visit scheduling, and workload balancing</li>
<li>Contribute to SOP development, workflow optimization, and quality improvement initiatives</li>
</ul>
<div>Qualifications and Requirements</div>
<ul><li>Education: Bachelor&rsquo;s degree in life sciences, nursing, or a related field</li>
<li>preferred</li>
<li>Experience: Minimum 4 to 6 years of clinical research coordination experience, including leadership or mentorship responsibilities</li>
<li>Certification: Clinical research certification (e.g., ACRP, SOCRA) preferred</li>
<li>Technical Skills: Proficiency in CTMS, E-Source, E-Reg, EDC platforms, and regulatory systems; strong computer literacy (Microsoft Office Suite, electronic communication tools)</li>
<li>Knowledge Base: Advanced understanding of clinical trial operations, GCP, FDA regulations, and IRB processes</li>
<li>Communication: Excellent written and verbal communication skills; ability to interact effectively with investigators, sponsors, staff, and participants</li>
<li>Leadership: Demonstrated ability to supervise, mentor, and develop staff while fostering accountability and collaboration</li>
<li>Organizational Skills: High attention to detail, time management, and multitasking capabilities; ability to prioritize competing demands</li>
<li>Flexibility: Willingness to adjust schedule to accommodate study visits, meetings, and events that may occur earlier, later, or on weekends</li>
<li>Travel: Ability to travel to training meetings, conferences, satellite sites and other Insight Health System locations as required</li>
<li>Professional Standards: Commitment to quality, compliance, participant safety, and continuous improvement</li></ul></div>

Clinical Research Coordinator III - Team Lead

Northwestern University

<div>
 
 Department:
 
 MED-Thoracic Surgery
 
 
 
 Salary/Grade:
 
 EXS/5
 
 
 
 Target hiring range for this position will be between be $51,346.00 - $72,532.00
 
 .
 
 Offered salary will be determined by the applicant&rsquo;s education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.
 
 
 
 
 Job Summary
 
 
 
 Manages daily operations of a biomedical &amp;/or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors &amp; other external project stakeholders. Monitors study performance, analyzes &amp; review results, &amp; supervises development &amp; implementation of protocols. Assigns work &amp; may provide oversight to study staff, as well as reviews technical operations ensuring that all processes, protocols &amp; procedures are quality controlled &amp; functioning up to standards. May co-author scientific papers for presentation &amp; publication &amp; coordinates writing, submission &amp; administration of grants. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) &amp; all current local, state, &amp; federal laws, regulations, guidance, policy &amp; procedure developed by the NU Institutional Review Board (IRB), Food &amp; Drug Administration (FDA) Code of Federal Regulations (CFR), &amp; the International Conference on Harmonization (ICH). Compliance with relevant policies of Northwestern University and Northwestern Memorial HealthCare.
 
 
 
 Specific Responsibilities
 
 
 
 Technical
 
 
 <ul>
 <li>
 Leads execution &amp; control of a biomedical &amp;/or social science project or research study.
 </li>
 <li>
 Manages and ensures completion of study activities per protocol. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment &amp; eligibility requirements; interviews participants &amp; obtains social &amp; medical histories; based on results determines &amp; registers participants with appropriate sponsors; completes informed consent; determines &amp; organizes patient's treatment and test schedules.
 </li>
 <li>
 Manages conduct of experimental tests &amp; procedures. Closely monitors &amp; documents patient's adverse events; partners with nursing staff in modifying dosages, tests &amp; treatment schedule.
 
 
 </li>
 </ul>
 Data
 
 
 <ul>
 <li>
 Manages project data including processing, accuracy, analysis &amp; evaluation of data ensuring that results meet project information and deliverable objectives. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress &amp; final reports.
 </li>
 <li>
 Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.
 
 
 </li>
 </ul>
 Administration
 
 
 <ul>
 <li>
 Manages project, collaborating and partnering with all internal/external staff including sponsoring agencies, organizations &amp;/or other research &amp;/or educational institutions to ensure project objectives and timelines are attained. Advises project staff on enhancements and changes to processes, practices, and procedures to ensure compliance with protocols and to increase effectiveness and efficiency of project.
 </li>
 <li>
 Manages day-to-day project operational &amp; business functions; implements existing policy &amp; ensures the effective, compliant, &amp; efficient completion of daily administrative operations.
 </li>
 <li>
 Ensures appropriate and timely compliance with associated local, state, &amp; federal regulatory guidelines, requirements, &amp; laws; &amp; research protocols.
 
 
 </li>
 </ul>
 
 Miscellaneous
 
 
 
 
 Performs other duties as assigned.
 
 
 
 
 Minimum Qualifications: (Education, experience, and any other certifications or clearances)
 
 
 
 <ul>
 <li>
 Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR
 </li>
 <li>
 Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 1 year research study or other relevant experience.
 
 
 </li>
 </ul>
 Must complete NU's IRB CITI training before interacting with any participants &amp; must re-certify every 3 years
 
 
 
 Minimum Competencies: (Skills, knowledge, and abilities.)
 
 
 
 <ul>
 <li>
 Ability to manage and maintain accurate clinical research documentation and data
 </li>
 <li>
 Familiarity with medical terminology and basic concepts in healthcare and clinical research
 </li>
 <li>
 Strong verbal and written communication skills for interacting with study participants, investigators, and other stakeholders
 </li>
 <li>
 Basic proficiency with Microsoft Office Suite (Word, Excel, Powerpoint)
 </li>
 <li>
 Ability to clearly explain study procedures and obtain informed consent from participants
 </li>
 <li>
 Ability to manage multiple tasks and prioritize effectively
 </li>
 <li>
 Strong attention to detail and accuracy in data collection and documentation
 </li>
 <li>
 Ability to work collaboratively in a team environment
 </li>
 <li>
 Professionalism and ethical conduct in handling sensitive information and interacting with study participants
 </li>
 <li>
 Sensitivity to the needs and concerns of study participants
 
 
 </li>
 </ul>
 Commitment to ensuring participant safety and well-being throughout the study
 
 
 
 Preferred Qualifications: (Education and experience)
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree and a minimum of 3 years or master&rsquo;s degree and minimum of 2 years prior experience in clinical research or related field,
 </li>
 <li>
 Certification in clinical research, such as Certified Clinical Research Coordinator (CCRC) or similar, and/or relevant, documented coursework or continuing education.
 </li>
 <li>
 Experience in patient interaction and data management in a clinical setting, preferably in an Academic Medical Center.
 
 
 </li>
 </ul>
 
 Preferred Competencies: (Skills, knowledge, and abilities)
 
 
 
 <ul>
 <li>
 Understanding of clinical research regulations and processes, including ethical and regulatory guidelines, such as Institutional Review Board (IRB) procedures and informed consent processes
 </li>
 <li>
 Awareness of patient privacy laws and data protection regulations, such as HIPAA
 </li>
 <li>
 Ability to identify and appropriately resolve issues that may arise during the conduct of a clinical trial or study
 </li>
 <li>
 Critical thinking skills to assess and address interpersonal challenges that arise when working with patients in a health care setting, protocol deviations, and other challenges
 
 
 </li>
 </ul>
 
 Benefits
 
 
 
 
 At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at
 
 
 https://www.northwestern.edu/hr/benefits/index.html
 
 
 to learn more.
 
 
 
 
 Work-Life And Wellness
 
 
 
 
 Northwestern offers comprehensive programs and services to help you and your family navigate life&rsquo;s challenges and opportunities, and adopt and maintain healthy lifestyles.
 
 
 
 
 We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at
 
 
 https://www.northwestern.edu/hr/benefits/work-life/index.html
 
 
 to learn more.
 
 
 
 
 Professional Growth &amp; Development
 
 
 
 
 Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you&rsquo;re interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at
 
 
 https://www.northwestern.edu/hr/learning/index.html
 
 
 to learn more
 
 .
 
 
 
 
 
 Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern&rsquo;s
 
 
 non-discrimination statement
 
 
 . Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View
 
 
 additional information on the accommodations process
 
 
 .
 
</div>

Clinical Research Coordinator

<div>
 Location: Chicago, Illinois
 
 
 Business Unit: Rush Medical Center
 
 
 Hospital: Rush University Medical Center
 
 
 Department: Pediatrics-Res Adm
 
 
 Work Type: Full Time (Total FTE between 0.9 and 1.0)
 
 
 Shift: Shift 1
 
 
 Work Schedule: 8 Hr (9:00AM - 5:30AM)
 
 
 Rush offers exceptional rewards and benefits learn more at our Rush benefits page (https://www.rush.edu/rush-careers/employee-benefits).
 
 
 Pay Range: $23.12 - $32.66 per hour
 
 
 Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush&rsquo;s anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case.
 
 
 
 Summary
 
 
 
 This position works under the general direction of the Office of Research Affairs' Clinical Research Administration Division, their clinical department / division, and in partnership with the Principal Investigator (PI), Co-investigator(s), other study personnel, and sponsoring agents to ensure protocols are conducted in accordance with the principles of Good Clinical Practice (GCP) S/he will coordinate standard clinical research studies conducted by PI(s) which may include grant-funded, industry sponsored, and investigator-initiated clinical research studies. S/he will perform a variety of routine duties involving the collection, compilation, and documentation of clinical research data. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.
 
 
 
 Required Job Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree and 1 year of clinical research experience OR 5 years of clinical research experience.
 </li>
 <li>
 Demonstrated knowledge of Good Clinical Practices and Good Documentation Practices.
 </li>
 <li>
 Demonstrated knowledge of current NIH and/or FDA regulations and guidelines related to clinical research.
 </li>
 <li>
 Ability to meet deadlines and help coordinate multiple aspects of the ongoing project.
 </li>
 <li>
 Strong organizational and problem-solving skills.
 </li>
 <li>
 Detail oriented with high attention to accuracy.
 </li>
 <li>
 Ability to build rapport, navigates sensitive topics, and maintains confidentiality with a diverse pool of research participants and vendors.
 </li>
 <li>
 Effective verbal and written communication skills.
 </li>
 <li>
 Ability to collaborate within multi-disciplinary team settings.
 </li>
 <li>
 Availability to work evenings, overnight and weekends if called for under the study protocols.
 </li>
 <li>
 Travel may be required.
 
 
 </li>
 </ul>
 
 Preferred Job Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Sciences or health-related discipline.
 </li>
 <li>
 Prior participant contact experience.
 
 
 </li>
 </ul>
 
 Responsibilities
 
 
 
 <ul>
 <li>
 Recruits, consents, screens, schedules, tracks and provides study updates to study participants throughout the conduct of the study.
 </li>
 <li>
 Collects and enters data into study case report forms and/or electronic data capture system and respond to queries in a timely manner.
 </li>
 <li>
 May submit or coordinate the submission of study related documents, study protocols and study protocol amendments to the IRB per policy and procedure
 </li>
 <li>
 Maintains accurate and complete procedural documentation including study participant and site level documentation in compliance with institutional, local, state and federal guidelines and regulations related to clinical research.
 </li>
 <li>
 May collect, process and ship potentially biohazardous specimens.
 </li>
 <li>
 Administers structured tests and questionnaires according to research study protocols. May utilize study-related technology and equipment as part of assessment procedures.
 </li>
 <li>
 Provide ongoing study status updates and responds to questions from PI, Administrator, Office of Research Affairs, Sponsor and Compliance throughout the conduct of the study
 </li>
 <li>
 Organize and participate in auditing and monitoring visits
 </li>
 <li>
 Gather and communicate unanticipated problems (protocol deviations, adverse events, and serious adverse events).
 </li>
 <li>
 Work with PI(s), sponsor, compliance, clinical staff and/or manager to identify and improve routine processes as it relates to the conduct of the research study
 
 
 </li>
 </ul>
 Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
</div>

Assoc Clinical Research Coord-19503

Milestone One

<div>
 
 Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery.
 
 
 
 
 
 
 Job Description
 
 
 
 
 The Site/Study Coordinator supports a medical institution in clinical trial-related activities. Protocol-specific tasks will be determined by the Principal Investigator, considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Tasks may include activities associated with the assessment of the feasibility of new/potential clinical studies, conducting research-related visits as outlined in the respective protocol, assisting the site with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in the research visit to assist in a smooth patient flow at research visits., general study conduct tasks, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution. In addition, mentoring staff and administrative tasks as assigned by the Milestone One Manager.
 
 
 
 
 
 
 In this job you will:
 
 
 
 
 
 <ul>
 <li>
 Acts as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution.
 </li>
 <li>
 Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time.
 </li>
 <li>
 Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria.
 </li>
 <li>
 Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff.
 </li>
 <li>
 Assists the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed.
 </li>
 <li>
 Assist with obtaining the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention or would prohibit or delay study treatment.
 </li>
 <li>
 Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual.
 </li>
 <li>
 Assist in scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution.
 </li>
 <li>
 Track patient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level. Provides regular updates to the staff and investigators regarding study amendments.
 
 </li>
 </ul>
 <ul>
 <li>
 Ensure accurate and timely data entry into study-specific EDC systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions.
 </li>
 <li>
 Support proper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintain the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding.
 </li>
 <li>
 Assist site staff with maintaining appropriate temperature monitoring for study products and supplies.
 </li>
 <li>
 Support the contract and budget negotiations and oversees Investigator/Site Payments.
 </li>
 <li>
 Ensure that all staff participating in a clinical trial complete all necessary study-specific and general training before their involvement in the trial. Retraining will be completed for changes to the protocol before site implementation.
 </li>
 <li>
 Be responsible for ensuring the investigator reviews and signs study documents appropriately and within a reasonable period. Guidance should be provided to educate the site research team on requirements for conducting clinical trials, date format, etc.
 </li>
 <li>
 Actively participate in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections.
 </li>
 <li>
 Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs).
 </li>
 <li>
 May be involved in the on-site training of additional staff as part of the SEO or other education programs.
 </li>
 <li>
 Assist with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements.
 </li>
 <li>
 Maintain all licensure and certifications applicable to the role of SEO site/Study coordinator II.
 </li>
 <li>
 SEO SC is responsible for only performing assigned tasks within their training and licensure if applicable. SEO SC should immediately consult the assigned Milestone One manager for tasks that do not fall within their scope.
 
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 
 
 Education
 
 
 
 
 
 
 Relevant education and at least two years of experience coordinating clinical research studies involving human subjects OR, if allowed by local regulations, on-the-job training with at least two years of experience coordinating clinical research studies involving human subjects.
 
 
 
 
 Nephrology experience preferred.
 
 
 
 
 
 
 Certifications
 
 
 
 
 
 <ul>
 <li>
 Current Good Clinical Practice (GCP)
 </li>
 <li>
 International Air Transport Association (IATA)
 </li>
 <li>
 Current Basic Cardiopulmonary Resuscitation (CPR)
 </li>
 <li>
 Phlebotomy certification unless part of active professional licensure (RN or LPN)
 </li>
 <li>
 Preferred Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization. May be obtained within (1) year of employment or status change if not currently certified.
 
 
 
 </li>
 </ul>
 
 Additional Information
 
 
 
 
 
 Located in South Cook/ Will County, Chicago (On-site position).
 
 
 
 
 
 If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you!
 
 
 
</div>

Clinical Study Coordinator

Explore 406+ Clinical research manager in Chicago this May. Find roles across top companies and apply now to boost your career.