clinical coordinator

assoc clinical research coord-19503 Jobs in Chicago

assoc clinical research coord-19503

associate fraud risk analyst Jobs in Chicago

associate fraud risk analyst

clinical recruiter

clinical research assistant Jobs in Chicago

clinical research assistant

clinical research associate

Rush University Medical Center

<div>Location: Chicago, Illinois
Business Unit: Rush Medical Center
Hospital: Rush University Medical Center
Department: Rush Alzheimers Dis Ctr-ResFac
Work Type: Full Time (Total FTE between 0.9 and 1.0)
Shift: Shift 1
Work Schedule: 8 Hr (8:00:00 AM - 4:30:00 PM)
Rush offers exceptional rewards and benefits learn more at our Rush benefits page (https://www.rush.edu/rush-careers/employee-benefits).
Pay Range: $17.63 - $24.91 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 Assistant in the Rush Alzheimer&rsquo;s department will assist with activities of clinical research studies conducted by PI(s) which may include grant-funded, industry sponsored, and investigator-initiated clinical research studies. This role will perform basic duties involving the collection, compilation, and documentation of clinical research data. The individual who holds this position exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.
<div>Required Job Qualifications:
 
<ul><li>High School Diploma.
</li><li>1 year of experience with prior data collection experience.
</li><li>Entry level proficiency in Microsoft Office, including spreadsheets and databases
</li><li>Ability to meet deadlines.
</li><li>Troubleshoots field issues when necessary. Uses discretion to resolve issues when unplanned events arise.
</li><li>Detail oriented with high attention to accuracy.
</li><li>Ability to build rapport, navigate sensitive topics, and maintain confidentiality with a diverse pool of research participants.
</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></ul></div><div>Responsibilities:
 
<ul><li>Administers involved, systematic tests and questionnaires including the assessment of participant eligibility, level of function, and/or response to intervention(s) according to research study protocols. May assist with recruitment, screening and scheduling
</li></ul>potential study participants.
 
<ul><li>Assists with collection and entry of data into study case report forms and/or electronic data capture system and respond to queries in a timely manner
</li><li>May collect and assist with the submission of study related documents, study protocols and study protocol amendments for submission to the IRB per policy and procedure
</li><li>Maintains accurate and complete documentation of signed informed consent and HIPAA Authorization forms, relevant IRB approvals, source documentation, study related communication as assigned.
</li><li>May collect, process and ship potentially biohazardous specimens
</li><li>May administer structured tests and questionnaires according to research study protocols.
</li><li>May utilize study-related technology and equipment as part of data collection procedures
</li><li>Gather and prepare study-related materials for participants visits
</li><li>Analyze data and drafts data reports, manuscripts, and presentations. 
</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 Assistant - Rush Alzheimer’s Disease Center

<div>Location: Chicago, Illinois
Business Unit: Rush Medical Center
Hospital: Rush University Medical Center
Department: Research Affairs-ResAdm
Work Type: Full Time (Total FTE between 0.9 and 1.0)
Shift: Shift 1
Work Schedule: 8 Hr (7:00:00 AM - 3:00:00 PM)
Rush offers exceptional rewards and benefits learn more at our Rush benefits page (https://www.rush.edu/rush-careers/employee-benefits).
Pay Range: $29.36 - $42.61 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 Regulatory Coordinator 2 (CRRC 2) prepares, submits, and maintains regulatory documents for clinical research studies across a range of study types including cooperative group, single-site, industry-sponsored, and investigator-initiated trials. This role manages regulatory workflows throughout the study lifecycle, including IRB submissions, institutional approvals, protocol updates, and documentation of compliance requirements. The CRRC 2 serves as the primary regulatory contact for assigned studies and collaborates with study teams to ensure version control, audit readiness, and regulatory accuracy.
 
 
Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.
Other information:
 
Required Job Qualifications:
 
 
Education: Bachelor&rsquo;s degree or equivalent
 
 
Experience: 2+ years clinical experience; 2 years coordinating Human Subjects research. 
 
 
 
 
Knowledge, Skills, &amp; Abilities
 
 
Knowledge of the Code of Federal Regulations pertaining to Human Subject Protections, including 45CFR46, 21CFR50 and 56, Good Clinical Practice, the Declaration of Helsinki, the Belmont Report and HIPAA, and RUMC policies and procedures.
 
 
Working knowledge of electronic IRB (eIRB) and institutional research management systems.
 
 
Ability to independently manage regulatory activities for multiple clinical trials, including industry, investigator-initiated, cooperative group, and single-site protocols.
 
 
Ability to serve as the primary regulatory contact, collaborating effectively with investigators, study staff, and institutional offices.
 
 
Ability to identify regulatory issues, apply critical thinking, and recommend workflow or compliance improvements.
 
 
Ability to maintain audit-ready documentation and ensure compliance with SOPs and sponsor requirements across the study lifecycle.
 
 
Ability to manage multiple timelines and competing deadlines effectively.
 
 
Proficient in Microsoft Office Suite (Word, Excel, Outlook) and Adobe Acrobat.
 
 
Clear verbal and written communication skills, including the ability to communicate complex concepts across diverse teams.
 
 
Advanced organizational and analytical skills with high attention to detail. 
 
 
 
 
Preferred Job Qualifications:
 
 
Education: Master&rsquo;s degree in science or health related field.
 
 
Experience: 1+ years of clinical research experience, in the academic or pharmaceutical clinical trials environment.
 
 
Certifications: Relevant certification from SOCRA or ACRP affiliated: Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), OR Certified IRB Professional (CIP) obtained within 6 months of hire 
 
 
 
 
Physical Demands: 
 
 
 
 
Competencies:
 
 
Ability to work independently with minimal guidance.
 
 
Ability to maintain audit-ready documentation and ensure compliance with SOPs and sponsor requirements.
 
 
Informal mentorship capabilities, including willingness to assist with onboarding new staff. 
 
 
 
 
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.
Responsibilities:
 
Job Responsibilities:
 
 
Draft and submit IRB materials such as consent forms, new study applications, continuing reviews, and reports of unanticipated problems.
 
 
Revise and finalize regulatory documents in response to IRB comments and submit updates within required timelines to support continued review and approval.
 
 
Prepare and submit required documents to institutional committees (e.g., PRMC, Radiation Safety, IBC) and track approvals to support study activation.
 
 
Manage regulatory activities for multiple clinical research studies, including cooperative group, single-site, industry-sponsored, and investigator-initiated trials.
 
 
Coordinate regulatory start-up by gathering, reviewing, and distributing documents needed for IRB, budget, contract, and coverage analysis processes.
 
 
Implement protocol amendments and maintain version control; coordinate updates with study teams and ensure compliance with the latest protocol and safety documents.
 
 
Prepare and update submission documents across the study lifecycle, ensuring alignment with institutional and sponsor requirements.
 
 
Serve as the designated regulatory contact and maintain audit-ready files throughout the study lifecycle.
 
 
Maintain detailed and up-to-date regulatory records that reflect protocol activity, compliance events, and IRB approvals.
 
 
Follow established SOPs and document regulatory actions in alignment with institutional, sponsor, and regulatory agency requirements.
 
 
Communicate study status updates and respond to stakeholder questions; prepare summary reports for investigators, sponsors, and institutional contacts as needed.
 
 
Assist with regulatory compliance tracking and monitor submission deadlines and approvals within the department.
 
 
Prepare and maintain compliance documents for departmental and institutional review, ensuring timely submission and recordkeeping.
 
 
Facilitate timely investigator review of safety reports and document assessments as required.
 
 
Recommend improvements to enhance compliance and workflow efficiency.
 
 
Collaborate with the study team to identify and report protocol deviations and assist in developing corrective and preventive actions (CAPAs).
 
 
Support onboarding by sharing regulatory tools, procedures, or guidance with new staff or study teams.
 
 
Stay informed of current regulatory guidance, GCP updates, and industry best practices. 
 
 
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 Regulatory Coordinator - Research Affairs-Full-time - Hybrid

Medix™

<div>
 
 
 
 Clinical Research Coordinator
 
 
 
 
 
 
 
 
 Must Haves:
 
 Bachelors degree, 3+ years of experience as a Clinical Research Coordinator, able to work independently
 
 
 
 Hours:
 
 40 hours per week, Monday-Friday onsite, normal business hours with some flexibility
 
 
 
 Contract Duration:
 
 contract-to-hire, 6 month contract then have the opportunity to be hired on permanently
 
 
 
 Benefits:
 
 Medical, Dental, Vision, time off, paid holidays off, 401k, growth opportunities, etc.
 
 
 
 
 
 
 About the Role
 
 
 
 
 
 
 
 
 
 
 Responsibilities
 
 
 
 
 
 <ul>
 <li>
 Schedules logistics, determines workflows, and secures resources for a defined clinical research trial(s)
 </li>
 <li>
 Recruits, screens, selects, determines eligibility and enrolls trial participants, collects information, and answers questions under supervision of a medically licensed professional.
 </li>
 <li>
 May perform basic medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing EKG&rsquo;s)
 </li>
 <li>
 Coordinates participant visits including liaising with appropriate departments to schedule tests, procedures, and other research visit needs.]
 </li>
 <li>
 Collects AE&rsquo;s, SAE&rsquo;s, concomitant medication, and other relevant medical data needed per protocols
 </li>
 <li>
 Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols
 </li>
 <li>
 Identifies work unit resources needs and manages supply and equipment inventory levels
 </li>
 <li>
 Serves as an initial point of contact for clinical research participants and clinical staff, providing information regarding research procedures, expectations, and informational inquiries. Ensures participants follow the research protocol and alerts Principal Investigator of issues
 </li>
 </ul>
 
 
 
 
 
 Required Skills
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in relevant area of study required
 </li>
 <li>
 Experience working with patients and families in clinical settings preferred
 </li>
 <li>
 Knowledge of biology or medicine gained through education or prior work experience preferred
 </li>
 <li>
 Must demonstrate sound clinical judgement, decision-making skills, and cultural sensitivity as part of consultative work
 </li>
 <li>
 Experience coordinating interventional clinical trials preferred
 </li>
 </ul>
 
 
 
 
 
 Preferred Skills
 
 
 
 
 
 <ul>
 <li>
 need someone located close to those areas or willing to commute to that area. We also need this person to be self-sufficient as they will be the only coordinator located at these sites for the time being. Of course, they will have support/resources from the other North/Northwest region staff but will be largely working autonomously.
 </li>
 </ul>
 
 
 
 
 
 
 
 
 
 
 Apply Today!
 
</div>

Clinical Research Coordinator - 249131

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

<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

Re:Cognition Health Limited

<div>ABOUT RE:COGNITION HEALTH
Re:Cognition Health is a pioneering brain and mind clinic that specializes in the treatment and care of people showing symptoms of cognitive impairment. Utilizing the latest progressive medical research and evidence-based treatments, we are passionate about transforming and optimizing cognitive performance through education, clinical excellence and by providing access to emerging treatments. 
We value people who are dedicated, hardworking and looking to contribute to the growth of our business at an exciting time. Our vision is to become the recognized worldwide leader in the diagnosis, treatment and care management of individuals experiencing cognitive impairment. Come join our team where everyone is valued and where critical and important work is being done! 
To find out more about our company, please visit https://recognitionhealth.com 
About the role<ul><li>
The post holder will be held accountable to the Senior Clinical Trials Coordinator (Chicago) for the highest standards of operational delivery of the Clinical Trials for which the post holder is appointed to co-ordinate. This includes responsibility for delivering these trials according to clinical trials &ldquo;Good Clinical Practice&rdquo; (GCP), ensuring appropriate resources, including professional skill mix, training and competency are in place at all times. Practice at the center is safe, performance at CRA visits, external monitoring visits and FDA inspections is planned and executed for optimal success.</li></ul>
What you'll do<ul><li>
To ensure that the highest levels of customer/patient care and clinical delivery are maintained at all times</li><li>
To support the development of the business by working closely with clinicians and consultants to maximize business opportunities and recruit patients</li><li>
Adhere to the organization&rsquo;s policies and SOPs and ensure all members of the clinical trials team are trained and compliant</li><li>
To ensure that all administration is performed accurately and in a timely way including the entry of patient records on all necessary databases and forms</li><li>
To ensure that all patient records are accurate, stored appropriately and all confidential information is retained in accordance with data protection requirements</li><li>
To ensure that the Center is maintained and presented to the highest standards as expected by</li><li>
The organization and that all equipment is calibrated and maintained in line with best practice</li><li>
To ensure adequate stock within the Center ensuring that it is ordered in a timely way and that stock is controlled</li><li>
To seek feedback from patients as to their experience and record these findings and analyze them to support the ongoing development of the service</li><li>
To be responsible for answering all queries and SAE and related IRB/FDA reporting within the time frames dictated for each study and GCP</li></ul>
Qualifications<ul><li>
5 years experience in Clinical Trials Coordination, operation, set-up and delivery.</li><li>
Proficiency in the use of Microsoft Office packages (Word, Excel, PowerPoint)</li><li>
Experience with electronic data capture (EDC) systems</li></ul></div>

Clinical Trials Coordinator

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

Explore 256+ Clinical research associate in Chicago this April. Find roles across top companies and apply now to boost your career.