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clinical research coordinator - 249131 Jobs in Chicago

clinical research coordinator - 249131

clinical research coordinator iii team lead

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

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

Milestone One

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

Clinical Study Coordinator

Rush University Medical Center

<div>Location: Chicago, Illinois
Business Unit: Rush Medical Center
Hospital: Rush University Medical Center
Department: Research Affairs-ResAdm
Work Type: Full Time (Total FTE between 0.9 and 1.0)
Shift: Shift 1
Work Schedule: 8 Hr (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

Northwestern Medicine

<div>The salary range for this position is $42.50 - $68.00 (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
The Transplant Nurse Coordinator reflects the mission, vision, and values of Northwestern Medicine, adheres to the organization&rsquo;s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines, and all other regulatory and accreditation standards.
The Transplant Nurse Coordinator - PNE is a Registered Nurse with experience in and knowledge of stem cell or organ transplantation and donation. Practicing under the supervision of transplant physicians, the Transplant Nurse Coordinator provides coordination through all phases of patient care. This position makes referrals to external clinicians or treatment programs or other community resources as appropriate and in accordance with established departmental protocols. Job duties may vary by specific department or assignment.
At Northwestern Medicine, we put our patients first in an effort to deliver the best care and to provide access to state-of-the-art therapies. Performing more than 400 stem cell transplant and cell therapies per year, our teams of experts are here to help support patients and their caregivers during all stages of their treatment journey.
The Transplant Nurse Coordinator will be a member of our Stem Cell Transplantation and Cell Therapy team, specifically dedicated to building a new clinical program: hematopoietic transplant and cell therapy for patients with severe, non-malignant diseases. This clinical program expands access to care for patients afflicted with debilitating neurologic and autoimmune diseases, currently a community of people with limited treatment options. Patients will be primarily be treated under clinical trials, advancing science through data and research.
Responsibilities:<ul><li>
Responsible for planning, directing, providing, and documenting appropriate care for patients in the designated care setting</li><li>
Assists in coordinating comprehensive care for patients, including assisting with the consent process, data collection and arranging any required follow-up visits, referrals, testing, treatment, and/or long-term follow-up</li><li>
Works collaboratively with the interdisciplinary team to coordinate on-going care, focused on cost-effective ways to maximize wellness and enhance patients&rsquo; lives</li><li>
Develops, coordinates, and provides education for patients, family, caregivers, and staff based on personalized needs along with serving as a resource for ongoing education</li><li>
Serves as a communication link between the patient, family, caregivers, interdisciplinary team, and outside hospitals/agencies</li><li>
Contributes to departments, hospitals, or other professional committees and/or quality or process improvement initiatives.</li><li>
Ensures clinical practice and patient care is consistent with policies, procedures, and regulatory requirements</li><li>
Other duties as assigned</li></ul>
Qualifications
Required:<ul><li>
Education<ul><li>
Bachelor of Science in Nursing (BSN)</li></ul></li><li>
License/Certification<ul><li>
Licensed Registered Nurse (RN) in the state of Illinois</li><li>
CPR-Basic Life Support (BLS)</li></ul></li><li>
Experience<ul><li>
Minimum 2-3 years of recent &amp; related clinical experience</li></ul></li></ul> 
Preferred:<ul><li>
License/Certification<ul><li>
Specialty certification in the clinical area of focus</li></ul></li><li>
Experience<ul><li>
Previous transplant or organ specific experience (i.e. hepatology, nephrology, hematologic malignancies, hematopoietic stem cell transplant, cellular therapies)</li></ul></li></ul>
Equal Opportunity<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>

Transplant Nurse Coordinator- Clinical Research Full Time Days

<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

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

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