clinical research coordinator i - cardiology

medical assistant

administrative assistant

assoc clinical research coord-19503 Jobs in Chicago

assoc clinical research coord-19503

clinical research coordinator - 249131 Jobs in Chicago

clinical research coordinator - 249131

clinical research coordinator i - cardiology Jobs in Chicago

clinical research assistant

University of Chicago

<div>
 
 Department
 
 
 
 BSD OCR - Research Incubation - Portfolio Development
 
 
 
 
 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 provides technical research support activities related to collecting, documenting, and reporting on basic clinical studies. Supports the administrative and operational tasks for clinical research conducted across the University.
 
 
 The Clinical Research Assistant is part of the Research Incubation Unit of the Office of Clinical Research. The Clinical Research Assistant (RA) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical research projects, the RA oversees, facilitates and coordinates the daily activities of clinical research and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. This position is housed within the Research Incubation Unit but will work specifically with investigators in the Orthopaedic Surgery Department. By performing these duties, the RA works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies.
 
 
 This position will have primary accountability to the Clinical Research Manager for the Department of Orthopaedic Surgery within the Office of Clinical Research.
 
 
 This at-will position is wholly or partially funded by contractual grant funding which is renewed under provisions set by the grantor of the contract. Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance.
 
 
 
 
 Responsibilities
 
 
 
 
 <ul>
 <li>
 Research tasks include recruitment, screening for eligibility, consenting participants, conducting research assessments, data entry, and subject follow-up and scheduling.
 </li>
 <li>
 Perform specific protocol procedures (specimens and data management, survey/questionnaire administration and the like) required to conduct the study and retain research subjects. Understands protocols and may collect information about adverse events (AEs), identified in the protocol or investigator brochure.
 </li>
 <li>
 Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
 </li>
 <li>
 May perform data abstraction and entry for retrospective chart review studies.
 </li>
 <li>
 Meets with the study PI on a regular basis to discuss study updates.
 </li>
 <li>
 Performs all tasks in basic clinical studies.
 </li>
 <li>
 Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
 </li>
 <li>
 Acquires and applies knowledge of clinical studies to collect analyzable clinical research data and/or samples.
 </li>
 <li>
 Performs other related work as needed.
 
 
 </li>
 </ul>
 
 
 Education:
 
 
 
 
 
 Minimum Qualifications
 
 
 
 Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).
 
 
 
 
 Work Experience:
 
 
 
 
 Minimum requirements include knowledge and skills developed through &lt; 2 years of work experience in a related job discipline.
 
 
 
 
 Certifications:
 
 
 
 
 
 Preferred Qualifications
 
 
 
 
 
 Education:
 
 
 
 
 <ul>
 <li>
 Bachelor's degree.
 
 
 </li>
 </ul>
 
 
 Experience:
 
 
 
 
 <ul>
 <li>
 2 years of work or volunteer experience in a health care related setting.
 
 
 </li>
 </ul>
 
 
 Preferred Competencies
 
 
 
 
 <ul>
 <li>
 Strong organizational skills.
 </li>
 <li>
 Excellent skills interacting with members of the public in a health care setting.
 </li>
 <li>
 Self-directed learner.
 
 
 </li>
 </ul>
 
 Working Conditions
 
 
 
 <ul>
 <li>
 Office, out-patient clinic, operating room, and sample processing lab.
 
 
 </li>
 </ul>
 
 Application Documents
 
 
 
 <ul>
 <li>
 Resume (required)
 </li>
 <li>
 Cover Letter (preferred)
 
 
 </li>
 </ul>
 When applying, the document(s)
 
 MUST
 
 be uploaded via the
 
 My Experience
 
 page, in the section titled
 
 Application Documents
 
 of the application.
 
 
 
 Job Family
 
 
 
 Research
 
 
 
 Role Impact
 
 
 
 Individual Contributor
 
 
 
 Scheduled
 
 
 Weekly Hours
 
 
 
 40
 
 
 
 
 Drug Test Required
 
 
 
 
 Yes
 
 
 
 
 Health Screen Required
 
 
 
 
 Yes
 
 
 
 
 Motor Vehicle Record Inquiry Required
 
 
 
 
 No
 
 
 
 Pay Rate Type
 
 
 
 Hourly
 
 
 
 FLSA Status
 
 
 
 Non-Exempt
 
 
 
 Pay Range
 
 
 
 $19.23 - $24.04
 
 
 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 Assistant

Rush University Medical Center

<div>Location: Chicago, Illinois
Business Unit: Rush Medical Center
Hospital: Rush University Medical Center
Department: Int Med Cardiology-Res Fac
Work Type: Full Time (Total FTE between 0.9 and 1.0)
Shift: Shift 1
Work Schedule: 8 Hr (8:30:00 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: $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.
Job Summary:
 
The Clinical Research Coordinator I (CRC I) supports the conduct of clinical research studies across a range of disciplines. Receives direction from principal investigator, supervisor, or other staff involved in research protocol(s). Responsibilities include participant recruitment and interaction, study data collection and entry, maintenance of study and regulatory documentation, sponsor communication, and adherence to study protocols and policies. The CRC I executes defined study tasks with guidance, ensuring operational compliance, accurate data entry, and participant safety. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.
<div>Required Job Qualifications:
 
Education:
 
<ul><li>Bachelor&rsquo;s degree
</li></ul>Experience:
 
<ul><li>0-2 years of experience in a research study or other relevant experience
</li></ul>OR
 
Experience (in lieu of a degree)
 
<ul><li>Two (2) years&rsquo; total experience, where 1 year is supporting or coordinating research studies 
</li></ul> 
 
Knowledge, Skills, &amp; Abilities:
 
<ul><li>Time Management &ndash; Ability to meet deadlines and manage assigned study tasks.
</li><li>Problem-Solving &ndash; Ability to troubleshoot routine field issues and use discretion to escalate appropriately when unplanned events arise.
</li><li>Attention to Detail &ndash; Strong attention to accuracy in data collection and documentation.
</li><li>Participant Relations &ndash; Ability to build rapport, navigate sensitive topics, and maintain participant confidentiality.
</li><li>Communication Skills &ndash; Effective verbal and written communication skills with participants and internal study teams.
</li><li>Team Collaboration &ndash; Ability to collaborate within multi-disciplinary team settings and follow established workflows.
</li><li>Flexibility &ndash; Availability to work evenings, overnight shifts, or weekends if required by study protocols.
</li><li>Travel Readiness &ndash; Availability for local travel as necessary.
</li><li>Other duties as assigned.
</li></ul> 
Preferred Job Qualifications:
 
Experience:
 
<ul><li>Two (2) or more years prior experience in clinical research or related field 
</li></ul> 
</div>Job Responsibilities:
 
1. Recruits, consents, screens, schedules, tracks and provides study updates to study participants throughout the conduct of the study.
 
2. Collects and enters data into study case report forms and/or electronic data capture system and responds to queries in a timely manner.
 
3. Assists in preparing simple data summaries, reports, or charts to support study documentation and reporting requirements.
 
4. 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.
 
5. Verifies data against 100% of source documentation for accuracy before entry into case report forms and electronic data capture systems to ensure timeliness and audit readiness.
 
6. May collect, process and ship potentially biohazardous specimens.
 
7. Administers structured tests and questionnaires according to research study protocols. May utilize study-related technology and equipment as part of assessment procedures.
 
8. Provide ongoing study status updates and responds to questions from PI, Administrator, department stakeholders, Sponsor and Compliance throughout the conduct of the study.
 
9. Maintains study flow by communicating promptly with study participants and coordinating with study team members as directed.
 
10. Participate in auditing and monitoring visits. Gather and communicate unanticipated problems (protocol deviations, adverse events, and serious adverse events).
 
11. 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.
 
12. Other duties as assigned. 
 
 
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 Coordinator I - Cardiology

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 Medicine

<div>The salary range for this position is $60.00 - $79.67 (Hourly Rate) 
 
Placement within the salary range is dependent on several factors such as relevant work experience and internal equity. For positions represented by a labor union, placement within the salary range is guided by the rules outlined in the collective bargaining agreement. 
 
We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events. Please visit our Benefits section located at jobs.nm.org/benefits to learn more. 
 
Northwestern Medicine is powered by a community of colleagues who are purpose-driven and committed to our mission to deliver world-class care. Here, you'll work alongside some of the best clinical talent in the nation leading the way in medical innovation and breakthrough research with Northwestern University Feinberg School of Medicine. 
 
We recognize where you've been, and we support where you're headed. We celebrate diverse perspectives and experiences, which fuel our commitment to equity and culture of service. 
 
Grow your career with comprehensive training and development opportunities, mentorship programs, educational support and student loan repayment. 
 
Create the life you envision for yourself with flexible work options, a Reimbursable Well-Being Fund and a Total Rewards package that support your physical, mental, emotional, and financial well-being. 
 
Make a difference through volunteer opportunities we offer in local communities and drive inclusive change through our workforce-led resource groups. 
 
From discovery to delivery, come help us shape the future of medicine. 
<div>Benefits:
<ul><li>$10,000 Tuition Reimbursement per year ($5,700 part-time)</li>
<li>$10,000 Student Loan Repayment ($5,000 part-time)</li>
<li>$1,000 Professional Development per year ($500 part-time)</li>
<li>$250 Wellbeing Fund per year ($125 for part-time)</li>
<li>Matching 401(k)</li>
<li>Excellent medical, dental and vision coverage</li>
<li>Life insurance</li>
<li>Annual Employee Salary Increase and Incentive Bonus</li>
<li>Paid time off and Holiday pay</li> 
</ul></div> 
 
Description
Northwestern Medicine has an exciting opportunity for either a Nurse Practitioner or a Physician Assistant to work in our inpatient Neurosurgery department. The APP will be working in a neurosurgery practice with 17 surgeons in multiple sub-specialties. This role manages inpatient neurosurgical patients.
Schedule: 4x10s, (M-F, off day TBD); optional shifts on Saturdays for extra pay; no nights or on-call
Essential Functions: 
<ul><li>
Demonstrates clinical expertise and expanded knowledge through patient care activities which may include diagnosis and management of a wide range of health problems.</li><li>
Responsible for health outcome of an assigned patient population.</li><li>
Confers with collaborating physician and other health professionals in area of clinical expertise.</li><li>
Develops appropriate educational systems for patients, families and staff in areas of expertise.</li><li>
Mentors graduate students in aspects of advanced practice and patient care.</li><li>
Actively participates in quality improvement and/or research pertinent to area of expertise.</li></ul>
Responsibilities: 
<ul><li>
Conducts comprehensive appraisals of patients' health status by taking health histories and performing physical examinations in clinical area.</li><li>
Provides direct clinical care to patients.</li><li>
Prescribes/orders medications, therapies; orders/interprets laboratory tests, x-rays and procedures according to clinical privileges.</li><li>
Evaluates patients to determine their need for further health care.</li><li>
Provides comprehensive teaching to patients and families.</li><li>
Documents in the medical record all care and education provided and/or procedures performed for which the Licensed Advanced Practice Provider is responsible.</li><li>
Refers to other disciplines as appropriate.</li><li>
Consultant to other disciplines in areas of expertise.</li><li>
Integrates research based knowledge and clinical expertise in decision making.</li><li>
Exemplifies a professional image in appearance, manner and presentation.</li><li>
Advocate for patients, families, coworkers, and the community.</li><li>
Maintains certifications and continuing education as required for licensure and privileging.</li><li>
Serves as a patient advocate and role model for &quot;Patients First&quot;.</li><li>
Participates in unit/departmental/divisional or hospital committees/task forces as appropriate.</li><li>
Provides comprehensive teaching strategies for patients and their families.</li><li>
Develops and participates in programs to meet continuing education needs of staff.</li><li>
Serves as a role model and preceptor to students.</li><li>
Provides formal education to both internal and external groups pertinent to area of specialty.</li><li>
Participates in quality improvement and/or research initiatives for specific patient population as appropriate.</li></ul>
Qualifications
Required:<ul><li>
Master&rsquo;s degree from an accredited school/college of nursing OR master's degree from an accredited Physician Assistant Program
</li><li>Acute care certification required for APRNs</li><li>
Current license as a Registered Nurse in the State of Illinois. Current license as an Advanced Practice Registered Nurse in the State of Illinois. Certification as an Advanced Practice Registered Nurse by a national certifying body as approved by the Illinois Department of Regulation APRN Board. Once licensed may apply for a controlled substance license and DEA number OR Master&rsquo;s degree from an accredited Physician Assistant Program/Current license as a Physician Assistant in the State of Illinois. Once licensed may apply for a controlled substance license and DEA number</li><li>
Privileged and credentialed through the NMH Medical Staff Office (MSO)</li><li>
Cardio-Pulmonary Resuscitation &ndash; BLS, issued by the American Heart Association</li><li>
Minimum of one (1) year of APP experience working with neurology or neurosurgery patient population</li></ul>
Preferred:<ul><li>
2 years of clinical experience in area of specialty.</li></ul>
Equal Opportunity
We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events. Please visit our Benefits section to learn more.<div></div>
Northwestern Medicine is an equal opportunity employer (disability, VETS) and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.
Background Check
Northwestern Medicine conducts a background check that includes criminal history on newly hired team members and, at times, internal transfers. If you are offered a position with us, you will be required to complete an authorization and disclosure form that gives Northwestern Medicine permission to run the background check. Results are evaluated on a case-by-case basis, and we follow all local, state, and federal laws, including the Illinois Health Care Worker Background Check Act.
Artificial Intelligence Disclosure
Artificial Intelligence (AI) tools may be used in some portions of the candidate review process for this position, however, all employment decisions will be made by a person.
Benefits
We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events. Please visit our Benefits section to learn more.
Sign-on Bonus Eligibility (if sign-on bonus offered for position): Internal employees and rehires who left Northwestern Medicine within 1 year are not eligible for the sign on bonus. Exception: New graduate internal employees seeking their first licensed clinical position at NM may be eligible depending upon the job family.</div>

Nurse Practitioner or Physician Assistant

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

<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

<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

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