clinical research manager

IQVIA

Chicago, United States of America | Full time | Home-based | R1553515
 <div><div>Join IQVIA and lead high-impact clinical projects that drive innovation and improve patient outcomes worldwide. We are seeking a strategic and people-focused leader to oversee global CPM teams, ensuring delivery excellence, strong financial performance, and exceptional client satisfaction.
<h3 class="jobSectionHeader">Role Overview</h3>
In this senior leadership role, you will provide oversight of CPM teams and corporate initiatives, driving productivity, quality, and on-time delivery across complex clinical programs. You will partner closely with clients and internal stakeholders to bring strategic direction, leverage therapeutic expertise, and ensure operational excellence across global teams.
You will also play a critical role in developing talent, building high-performing teams, and fostering a culture of accountability, collaboration, and continuous improvement.
<h3 class="jobSectionHeader">Key Responsibilities</h3>
<ul><li>Lead and develop a team of CPM managers, ensuring delivery of clinical programs on time, within budget, and to quality standards</li>
<li>Drive operational excellence through strong project oversight, risk management, and performance monitoring</li>
<li>Coach and mentor leaders on project execution, problem-solving, and strategic planning</li>
<li>Ensure alignment with global processes, tools, and best practices</li>
<li>Monitor project metrics and proactively address risks, quality issues, and resource needs</li>
<li>Partner with clients to provide guidance on clinical development strategy and delivery</li>
<li>Contribute to corporate initiatives and act as a cross-functional leader within IQVIA</li>
<li>Attract, develop, and retain top talent while supporting ongoing learning and development</li>
</ul><h3 class="jobSectionHeader">Qualifications</h3>
<ul><li>Bachelor&rsquo;s degree in life sciences or related field</li>
<li>~15+ years of clinical research experience, including significant leadership in global/multi-regional environments</li>
<li>Deep knowledge of clinical trials, GCP/ICH guidelines, and the clinical research landscape</li>
<li>Proven ability to lead teams, influence stakeholders, and deliver complex programs successfully</li>
<li>Strong business acumen, including project financials and performance metrics</li>
<li>Excellent communication, collaboration, and leadership skills</li>
</ul><h3 class="jobSectionHeader">What We&rsquo;re Looking For</h3>
<ul><li>A strategic leader who can balance operational delivery with long-term vision</li>
<li>Strong people manager with a passion for coaching and developing talent</li>
<li>Ability to navigate complexity, drive results, and build strong client relationships in a global environment</li>
</ul></div>IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $125,900.00 - $394,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</div>

(Senior) Director, Clinical Project Management

Johnson & Johnson

<div>
 At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
 
 
 As guided by Our Credo, Johnson &amp; Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.
 
 
 
 Job Function
 
 
 
 MedTech Sales
 
 
 
 Job Sub Function
 
 
 
 Clinical Sales &ndash; Specialty Physicians (Commission)
 
 
 
 Job Category
 
 
 
 Professional
 
 
 
 All Job Posting Locations:
 
 
 
 Chicago, Illinois, United States
 
 
 
 Job Description
 
 
 
 Fueled by innovation at the intersection of biology and technology, we&rsquo;re developing the next generation of smarter, less invasive, more personalized treatments.
 
 
 Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that&rsquo;s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world&rsquo;s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
 
 
 Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
 
 
 We are searching for the best talent for a field-based Clinical Representative role to support procedural excellence, customer education, and utilization growth within the Chicago, IL territory.
 
 
 
 Purpose
 
 
 
 The MONARCH&trade; Platform was first introduced in 2018, creating a new category of care as the first endoluminal robotic-assisted bronchoscopy system designed to help physicians access small, hard-to-reach lung nodules to enable earlier diagnosis of lung cancer. The Monarch Platform for Urology will soon create a new category of care as the first robotic-assisted urology system designed for endoluminal and percutaneous access of organs across the urinary tract to perform various diagnostic and therapeutic procedures.
 
 
 
 You Will Be Responsible For
 
 
 
 <ul>
 <li>
 Provide in-case procedural support and technical expertise to physicians, nurses, and staff using Monarch Urology in hospital and ambulatory surgery center environments.
 </li>
 <li>
 Help create and maintain strong customer relationships through consistent clinical support, training, education, and responsive service.
 </li>
 <li>
 Support account development activities that build clinical confidence, increase user competence, and drive system and disposable utilization.
 </li>
 <li>
 Assist with product and clinical demonstrations, launch planning, training events, and customer education initiatives.
 </li>
 <li>
 Identify and act on educational opportunities that improve customer proficiency, procedural efficiency, and clinical adoption.
 </li>
 <li>
 Partner with the Area Sales Leader and Regional Business Director to support business objectives, account plans, and referral development activities.
 </li>
 <li>
 Serve as a liaison between customers and internal teams for questions, issue escalation, peer-to-peer review needs, and timely reporting of complaints or technical concerns.
 </li>
 <li>
 Develop and maintain expert-level product knowledge and a strong understanding of kidney stone treatment workflows, customer needs, and procedural best practices.
 </li>
 <li>
 Deliver a high standard of professionalism, service, and compliance in all customer interactions.
 </li>
 <li>
 Lead and support sales activities at the account level ensuring products are purchased and in-stock to support procedures and growth of the account.
 
 
 </li>
 </ul>
 The expected base pay for this position is: $90,000 for Senior Clinical Representative and $70,000 for Clinical Representative.
 
 
 <li>
 The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan.
 </li>
 <li>
 This position is eligible for either a company car or a car allowance through the Company&rsquo;s FLEET program.
 </li>
 <li>
 Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
 </li>
 <li>
 Subject to the terms of their respective plans, employees are eligible to participate in the Company&rsquo;s consolidated retirement plan (pension) and savings plan (401(k)).
 </li>
 <li>
 This position is eligible to participate in the Company&rsquo;s long-term incentive program.
 </li>
 <li>
 Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits:
 </li>
 <ul>
 <li>
 Vacation &ndash;120 hours per calendar year
 </li>
 <li>
 Sick time - 40 hours per calendar year; for employees who reside in the State of Washington &ndash;56 hours per calendar year
 </li>
 <li>
 Holiday pay, including Floating Holidays &ndash;13 days per calendar year
 </li>
 <li>
 Work, Personal and Family Time - up to 40 hours per calendar year
 </li>
 <li>
 Parental Leave &ndash; 480 hours within one year of the birth/adoption/foster care of a child
 </li>
 <li>
 Condolence Leave &ndash; 30 days for an immediate family member: 5 days for an extended family member
 </li>
 <li>
 Caregiver Leave &ndash; 10 days
 </li>
 <li>
 Volunteer Leave &ndash; 4 days
 </li>
 <li>
 Military Spouse Time-Off &ndash; 80 hours
 </li>
 <li>
 For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
 </li>
 <li>
 This job posting is anticipated to close on Monday, June 8, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
 
 
 </li>
 </ul>
 
 Qualifications/Requirements
 
 
 
 <ul>
 <li>
 A bachelor&rsquo;s degree plus a minimum of 3 years of relevant experience is required; alternatively, an associate degree or medical certification plus a minimum of 5 years of relevant experience may be considered.
 </li>
 <li>
 Clinical, medical device technical and/or sales, procedural support, operating room, or healthcare-related experience is required.
 </li>
 <li>
 Experience in urology, endourology, surgical robotics, or another highly technical procedural specialty is preferred.
 </li>
 <li>
 Demonstrated ability to learn and communicate technical and clinical concepts to physicians and clinical staff is required.
 </li>
 <li>
 Strong customer service, organization, and collaboration skills are required.
 </li>
 <li>
 Ability to work in all departments of the hospital and in ambulatory surgery center environments, including live patient cases and required protective equipment, is required.
 </li>
 <li>
 Hospital credentialing and compliance with customer access requirements are required.
 </li>
 <li>
 Ability to travel extensively, including overnight travel, up to 90% within the assigned territory is required.
 </li>
 <li>
 A valid driver&rsquo;s license is required.
 </li>
 <li>
 Ability to work in a regulated environment in compliance with applicable quality and healthcare industry requirements is required.
 
 
 </li>
 </ul>
 This position operates in a field-based clinical support environment and requires frequent travel across the assigned territory. The role involves extensive time in hospital and procedural settings, including case support, education, and customer coordination, and requires comfort working autonomously while partnering closely with the broader commercial team.
 
 
 Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
 
 
 Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
 
 
 
 Required Skills
 
 
 
 
 Preferred Skills:
 
 
 
 Analytical Reasoning, Business Behavior, Business Development, Customer Analytics, Data Reporting, Execution Focus, Goal-Oriented, Innovation, Market Research, Product Costing, Product Development, Product Lifecycle Management (PLM), Project Administration, Sales Enablement, Sales Support, Sustainable Procurement, Vendor Selection
 
 
 
 The anticipated base pay range for this position is :
 
 
 
</div>

Clinical Representative - Chicago, IL

Flourish Research

<div>About Us
Flourish Research is where clinical trials thrive. Flourish Research is one of the industry&rsquo;s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!
Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.
About the Job:
We are actively hiring a Clinical Research Coordinator to support our Chicago, IL site. 
 
Shift: Monday-Friday normal work hours 
Location: Onsite 
FLSA Classification: Non-Exempt 
Compensation: 65,000.00-$75,000.00
ESSENTIAL JOB FUNCTIONS:<ul><li>
Read, understand, and can accomplish protocol specified patient visits and procedures.</li><li>
Clearly and concisely document patient assessments, observations, test results and other study related information per federal regulations, protocol requirements and GCPs.</li><li>
Obtain patient informed consent according to federal regulations, GCPs and IRB requirements.</li><li>
Is creative and diligent in recruiting qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor&rsquo;s timeline while following regulations and rules governing medical ethics, IRB, GCP and ICH guidelines.</li><li>
Complete all required training in a timely manner.</li><li>
Schedule and conduct patient visits according to protocol requirements and timelines.</li><li>
Maintain accurate and complete written source documentation of patient visits and protocol related activities.</li><li>
Accurately complete case report forms (CRFs &amp;/or eCRFs) and/or worksheets generated by the sponsor.</li><li>
Maintain confidentiality of patient and protocol issues as appropriate and as bound by Confidentiality Agreements with Flourish Research, between Flourish and sponsors, and between Flourish and other entities, as well as HIPAA regulations.</li><li>
Promptly report adverse events to supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary.</li><li>
Report Serious Adverse Events (SAEs) to sponsor within 24 hours of becoming aware of the SAE.
</li><li>Also report the SAE to the supervisor, Principal Investigator and/or Sub-Investigator.</li><li>
Account for clinical trial materials (i.e., CRFs, study drug, lab supplies, and/or other required items) and ensure availability of appropriate amounts for the conduct of the study.</li><li>
Maintain ongoing communication with Team Lead I; Team Manager; Principal Investigator; Sub Investigators and other people assisting with the trial and documenting these communications according to protocol requirements and Flourish policies.</li><li>
Attend required training courses/conferences in order to stay abreast of current and changing federal regulations and Flourish policies.
</li><li>Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research.</li><li>
Attend Investigator Meetings and/or other training as directed.</li><li>
Perform all study-related duties in a time- and cost-effective manner in adherence with Flourish policies.</li><li>
Perform all duties in a safe and prudent manner.</li><li>
Perform other duties as assigned.</li><li>
Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with Flourish staff, sponsors, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals, and physician&rsquo;s offices.</li><li>
Additional duties as assigned by management.</li></ul>
PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:<ul><li>
Work is normally performed in a typical interior/office work environment.</li><li>
Travel required.</li><li>
Exposure to human bodily fluids.</li><li>
Laboratory processing procedures.</li><li>
Subject/Patient care.</li><li>
Daily computer use.</li><li>
Occasional night and weekend work schedules.</li><li>
The ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.</li><li>
The ability to drive, and daily availability of an automobile</li></ul> 
Requirements 
<ul><li>
Bachelor's degree preferred; however, is not required.</li><li>
Preferably a minimum of 2 years&rsquo; experience as a CRC, plus 1-3+ years' minimum experience within the field of clinical research or biological research.</li></ul>
Knowledge and Skills:<ul><li>
Exceptional knowledge of clinical research methods.</li><li>
Strong management and leadership skills.</li><li>
Demonstrated ability to collaborate and align with operations.</li><li>
Excellent oral and written communication skills.</li><li>
Excellent computer skills to include Office365 products.</li><li>
Experience in writing and reviewing Standard Operating Procedures.</li><li>
Strong problem solving, risk assessment and impact analysis abilities.</li><li>
Demonstrated experience in process improvement.</li><li>
Strong negotiation and conflict management skills.</li><li>
Flexible and able to multi-task and prioritize competing demands.</li><li>
Ability to think independently and influence when appropriate.</li></ul> 

Benefits 
Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays.
Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.</div>

Clinical Research Coordinator

The University of Chicago

<div>Department
BSD OCR - CTMS Support Unit 
About the Department
The Office of Clinical Research (OCR) is dedicated to supporting the infrastructure for the management and administration of clinical research at The University of Chicago as well as individual research programs with the goal of improving communication, consistency, and collaboration across the Biological Sciences Division and UChicago Medicine.
 
 
To mission of the OCR 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. 
Job Summary
The job maintains regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits. With a moderate level of direction, participates in compliance documentation, compliance training, and compliance committee formation. 
 
The Coverage Analyst is dedicated to ensuring billing compliance for clinical research and supports utilization of the Clinical Trial Management System (CTMS), Oncore. The Coverage Analyst plays a crucial role in evaluating clinical research protocols, informed consent forms, clinical trial budgets, and other pertinent study documents to generate a protocol calendar in the CTMS system and develop coverage analysis/billing grid. The Coverage Analyst specifies which procedures and services may qualify as 'Routine Cost' and be billable to patient insurance, and which should be charged to the study. The Coverage Analyst is responsible for determining whether proposed clinical research studies meet the criteria for a Qualifying Clinical Trial as defined by the Medicare Clinical Trial Policy (NCD 310.1). As a member of the Research Systems &amp; Coverage Analysis (RSCA) Unit, within the Office of Clinical Research, the Coverage Analysts works as part of a team to support and optimize clinical trial initiation and financial workflows, partnering closely with research teams and key stakeholders in the process.
Responsibilities<ul><li>
Reviews clinical trial protocols, budgets, contracts, and informed consent documents to inform billing designations.</li><li>
Creates detailed coverage analyses that outline the billing of clinical items and services required by research studies.</li><li>
Develops study calendars within the Clinical Trial Management System, Oncore.</li><li>
Ensures consistency in the application of Medicare and other applicable rules across studies and alignment of study documents with billing regulations.</li><li>
Works collaboratively with key offices, including the Human Research Protection Program and research units, to harmonize regulatory and budgetary processes in clinical trials.</li><li>
Communicates the results of coverage analyses to principal investigators and/or study teams, providing detailed explanations and addressing any questions or concerns.</li><li>
Ensures that coverage analyses outputs are reviewable and auditable for quality and compliance.</li><li>
Recruits, onboards, and trains new clinical research staff to ensure adherence to billing compliance procedures.</li><li>
Coordinates department or clinic compliance with a moderate level of guidance.</li><li>
Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.</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 2-5 years of work experience in a related job discipline. 
Certifications:
-
Preferred Qualifications
Education:<ul><li>
Bachelor's degree.</li></ul>
Experience:<ul><li>
Clinical research experience such as clinical research conduct, regulatory compliance, or related research activities.</li><li>
Coverage analysis experience.</li></ul>
Preferred Competencies<ul><li>
Interpret research protocols, budgets, and consent forms to extrapolate billing/coverage information.</li><li>
Problem-solve, leveraging information and expertise available.</li><li>
Strong organizational skills.</li><li>
Manage projects at various stages of completion.</li><li>
Manage high volume of workload and meet deadlines.</li><li>
Demonstrated attention to detail.</li></ul>
Working Conditions<ul><li>
Office environment.
</li></ul>Application Documents<ul><li>
Resume (required)</li><li>
Cover Letter (preferred)</li></ul> 
The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions. 
 
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application. 
Job Family
Legal &amp; Regulatory Affairs 
Role Impact
Individual Contributor 
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
$65,000.00 - $90,000.00
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 Coverage Analyst

Cardiovascular Associates of America - CVAUSA

<div>
 
 
 Clinical Research Data Assistant
 
 This will be an in-person position in Chicago, Illinois&nbsp;
 
 
 
 
 Position Summary
 
 
 
 The Clinical Research Data Assistant provides administrative, data management, and study support services for clinical research studies. This position is responsible for sponsor system data entry, study reporting, document management, regulatory support, and research communications.
 
 
 The Clinical Research Data Assistant works closely with Clinical Research Coordinators, investigators, sponsors, and the regulatory team to ensure accurate, timely, and compliant study documentation and reporting.
 
 
 
 Essential Responsibilities
 
 
 
 
 Data Management
 
 
 
 &middot; Enter study data into sponsor electronic data capture (EDC) systems.
 
 
 &middot; Transcribe source documentation into sponsor systems accurately and timely.
 
 
 &middot; Review entered data for completeness and accuracy.
 
 
 &middot; Resolve basic data discrepancies and escalate complex issues.
 
 
 &middot; Maintain study tracking logs and databases.
 
 
 
 Sponsor Systems Management
 
 
 
 &middot; Maintain user access and system tracking documentation.
 
 
 &middot; Upload required documents into sponsor portals.
 
 
 &middot; Monitor sponsor system notifications and alerts.
 
 
 &middot; Support completion of sponsor-required documentation.
 
 
 
 Screening, Enrollment, and Study Reporting
 
 
 
 &middot; Prepare routine reports on screening, enrollment, randomization, and retention metrics.
 
 
 &middot; Track recruitment and enrollment performance.
 
 
 &middot; Maintain study enrollment dashboards and tracking tools.
 
 
 &middot; Generate reports for site leadership and study teams.
 
 
 
 Regulatory and Document Support
 
 
 
 &middot; Route study documents for review and signature.
 
 
 &middot; Assist with collection of regulatory documents.
 
 
 &middot; Maintain electronic and paper study files.
 
 
 &middot; Support regulatory filing activities.
 
 
 &middot; Assist with investigator and staff training documentation.
 
 
 
 Communication Management
 
 
 
 &middot; Manage study email inboxes.
 
 
 &middot; Route sponsor communications to appropriate team members.
 
 
 &middot; Track action items from sponsor correspondence.
 
 
 &middot; Assist with scheduling sponsor meetings and study-related calls.
 
 
 Coordinator and Site Support
 
 
 &middot; Provide administrative support to Clinical Research Coordinators and investigators.
 
 
 &middot; Assist with study start-up documentation.
 
 
 &middot; Support study close-out activities.
 
 
 &middot; Assist with preparation for sponsor monitoring visits, audits, and inspections.
 
 
 
 Quality and Compliance
 
 
 
 &middot; Maintain confidentiality of participant information.
 
 
 &middot; Ensure data accuracy and completeness.
 
 
 &middot; Follow Good Clinical Practice (GCP), sponsor requirements, and site SOPs.
 
 
 &middot; Participate in quality improvement initiatives.
 
 
 
 Qualifications
 
 
 
 
 Education
 
 
 
 &middot; High School Diploma required.
 
 
 &middot; Associate's degree or Bachelor's degree preferred.
 
 
 
 Experience
 
 
 
 &middot; Previous healthcare, data entry, administrative, research, or regulatory experience preferred.
 
 
 &middot; Experience with electronic systems and databases preferred.
 
 
 
 Knowledge, Skills, and Abilities
 
 
 
 &middot; Exceptional attention to detail.
 
 
 &middot; Strong data entry and computer skills.
 
 
 &middot; Strong written and verbal communication skills.
 
 
 &middot; Ability to manage multiple deadlines.
 
 
 &middot; Strong organizational skills.
 
 
 &middot; Proficiency in Microsoft Office applications, particularly Excel.
 
 
 &middot; Ability to learn sponsor systems, CTMS, eSource, and eRegulatory platforms.
 
 
 
 Physical Requirements
 
 
 
 &middot; Ability to perform prolonged computer-based work.
 
 
 &middot; Ability to review detailed documentation for extended periods.
 
 
 &middot; Ability to occasionally lift and move files or supplies up to 15 pounds.
 
</div>

Clinical Research Data Assistant

Cardiovascular Associates of America

<div>Clinical Research Data Assistant 
This will be an in-person position in Chicago, Illinois
Position Summary
The Clinical Research Data Assistant provides administrative, data management, and study support services for clinical research studies. This position is responsible for sponsor system data entry, study reporting, document management, regulatory support, and research communications.
The Clinical Research Data Assistant works closely with Clinical Research Coordinators, investigators, sponsors, and the regulatory team to ensure accurate, timely, and compliant study documentation and reporting.
Essential Responsibilities
Data Management<ul><li>Enter study data into sponsor electronic data capture (EDC) systems.</li><li>Transcribe source documentation into sponsor systems accurately and timely.</li><li>Review entered data for completeness and accuracy.</li><li>Resolve basic data discrepancies and escalate complex issues.</li><li>Maintain study tracking logs and databases.</li></ul>
Sponsor Systems Management<ul><li>Maintain user access and system tracking documentation.</li><li>Upload required documents into sponsor portals.</li><li>Monitor sponsor system notifications and alerts.</li><li>Support completion of sponsor-required documentation.</li></ul>
Screening, Enrollment, and Study Reporting<ul><li>Prepare routine reports on screening, enrollment, randomization, and retention metrics.</li><li>Track recruitment and enrollment performance.</li><li>Maintain study enrollment dashboards and tracking tools.</li><li>Generate reports for site leadership and study teams.</li></ul>
Regulatory and Document Support<ul><li>Route study documents for review and signature.</li><li>Assist with collection of regulatory documents.</li><li>Maintain electronic and paper study files.</li><li>Support regulatory filing activities.</li><li>Assist with investigator and staff training documentation.</li></ul>
Communication Management<ul><li>Manage study email inboxes.</li><li>Route sponsor communications to appropriate team members.</li><li>Track action items from sponsor correspondence.</li><li>Assist with scheduling sponsor meetings and study-related calls.</li></ul>
Coordinator and Site Support<ul><li>Provide administrative support to Clinical Research Coordinators and investigators.</li><li>Assist with study start-up documentation.</li><li>Support study close-out activities.</li><li>Assist with preparation for sponsor monitoring visits, audits, and inspections.</li></ul>
Quality and Compliance<ul><li>Maintain confidentiality of participant information.</li><li>Ensure data accuracy and completeness.</li><li>Follow Good Clinical Practice (GCP), sponsor requirements, and site SOPs.</li><li>Participate in quality improvement initiatives.</li></ul>
Qualifications
Education<ul><li>High School Diploma required.</li><li>Associate's degree or Bachelor's degree preferred.</li></ul>
Experience<ul><li>Previous healthcare, data entry, administrative, research, or regulatory experience preferred.</li><li>Experience with electronic systems and databases preferred.</li></ul>
Knowledge, Skills, and Abilities<ul><li>Exceptional attention to detail.</li><li>Strong data entry and computer skills.</li><li>Strong written and verbal communication skills.</li><li>Ability to manage multiple deadlines.</li><li>Strong organizational skills.</li><li>Proficiency in Microsoft Office applications, particularly Excel.</li><li>Ability to learn sponsor systems, CTMS, eSource, and eRegulatory platforms.</li></ul>
Physical Requirements<ul><li>Ability to perform prolonged computer-based work.</li><li>Ability to review detailed documentation for extended periods.</li><li>Ability to occasionally lift and move files or supplies up to 15 pounds.</li></ul>
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<div>Department
BSD MED - Cardiology - Clinical Research Staff 
About the Department
The Section of Cardiology was founded in 1950 and has a proud history. We are now charting a new course that will propel us to the forefront of cardiovascular medicine. The strength of the Section reflects the quality and dedication of its faculty, trainees and support staff and is enhanced by the rich environment at the University of Chicago. 
Job Summary
The Clinical Research Coordinator 1 provides support to the faculty of the Section of Cardiology within the Biological Sciences Division.
Responsibilities<ul><li>
Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.</li><li>
Collect, process, ship &amp; store specimens to appropriate laboratory according to established techniques.</li><li>
Coordinate the conduct of the study from startup through closeout, including recruiting, interviewing and &amp; screening of study subjects, obtaining informed consent, collecting research data, &amp; ensuring protocol adherence.</li><li>
Plan &amp; coordinate patient schedule for study procedures, return visits, and study treatment schedules.</li><li>
Educate patients about study procedures to be performed, visit schedule, what to report between &amp; during visits, and the risks / benefits of the procedures.</li><li>
Perform assessments at patient study visits and monitor for adverse events.</li><li>
Serve as a resource person to patients on trials.</li><li>
Act as a collaborator within the department/unit through improving clinical research practice and serving as a resource.</li><li>
Maintain working knowledge of current protocols, and internal SOPs.</li><li>
Be accountable for high standards of clinical research practice and assist in the development of accountability in others.</li><li>
Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.</li><li>
Assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.</li><li>
Provide support to other CRCs and research-related staff, as needed.</li><li>
Maintain accurate and complete records which may include (but are not limited to) signed informed consents, source documentation, Case Report Forms, drug dispensing logs, and study related communication.</li><li>
Analyze study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, progress reports, etc.</li><li>
Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.</li><li>
Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.</li><li>
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.</li><li>
Accountable for all tasks in basic clinical studies.</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 &lt; 2 years of work experience in a related job discipline. 
Certifications:
-
Preferred Qualifications<div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div>
Education:
<ul><li>Bachelor's degree.</li></ul> 
Experience:
<ul><li>Knowledge of medical terminology/environment.</li></ul>
Preferred Competencies<ul><li>
Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.</li><li>
Ability to communicate with tact and diplomacy.</li><li>
Strong organizational skills.</li><li>
Strong communication skills (verbal and written).</li><li>
Excellent interpersonal skills.</li><li>
Strong data management skills and attention to detail.</li><li>
Knowledge of Microsoft Word, Excel and Adobe Acrobat.</li><li>
Ability to understand complex documents (e.g., clinical trials).</li><li>
Ability to handle competing demands with diplomacy and enthusiasm.</li><li>
Ability to absorb large amounts of information quickly.</li><li>
Adaptability to changing working situations and work assignments.</li></ul>
Application Documents<ul><li>
Resume (required)</li><li>
Cover Letter (required)</li></ul></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div> 
The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions. 
 
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
Salary 
 
FLSA Status
Exempt 
 
Pay Range
$50,000.00 - $65,000.00
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 Coordinator 1

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