clinic coordinator - dermatology

clinical coordinator

clinical coordinator part-time Jobs in Chicago

clinical coordinator part-time

clinical research assistant Jobs in Chicago

clinical research assistant

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

clinical trials coordinator

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

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

The University of Chicago

<div>Department
BSD IPP&ndash;NPH 
About the Department
The Institute for Population and Precision Health (IPPH), located in the Biological Sciences Division, integrates a wide spectrum of factors such as human health behaviors, environmental factors, social and economic factors, policies and genetic determinants of health, into studies focused on the treatment and prevention of disease, as well as the maintenance of wellness. Leveraging and integrating the University of Chicago&rsquo;s considerable institutional strength in population science with research spanning diverse fields such as genetic medicine, cancer epidemiology, microbiome, and epigenomics, the Institute will have the common goal of improving human health outcomes. Another major goal of the Institute will be to develop a new multidisciplinary training program to equip researchers with emerging tools and methods to conduct precision health research within a population health framework. Our faculty lead research projects in biostatistics, epidemiology and health services research and participate in interdisciplinary teams with faculty in other departments to address complex problems in health and healthcare, in our communities and around the globe. 
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. 
Job Information
Job Summary:
While the Principal Investigator (PI) is primarily responsible for the overall design, conduct, and management of clinical trials. Under the direction of the PI, Co-Investigators, Advanced Practice Registered Nurses (APRNs) and Research Manager (RM), the Clinical Research Nurse Coordinator oversees, facilitates, and participates in the conduct of daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. The Clinical Research Nurse Coordinator acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others. By performing these duties, the Clinical Research Nurse Coordinator 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.
Responsibilities:<ul><li>
Coordinate and participate in the conduct of clinical research trials at the Institute for Population and Precision Health (IPPH).</li><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>
Develop and implement study procedures, maintains study records, tracks study progress, and conducts quality assurance on study data collected.</li><li>
Prepare, submit, and assist investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).</li><li>
Provide direct supervision of other research staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.</li><li>
Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.</li><li>
Conduct clinical study tasks including physical assessment of subjects, taking vital signs, recording medical, surgical, social and behavioral histories, and phlebotomy skills.</li><li>
Serve as a resource person or act as a consultant within area of clinical expertise.</li><li>
Act as a leader 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 study standard operating protocols and procedures as well as federal and institutional regulations.</li><li>
Provide Investigators with guidance regarding protocol requirements.</li><li>
Maintain regulatory documentation.</li><li>
Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.</li><li>
Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.</li><li>
Applies logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.</li><li>
Interprets information from caregivers, nurses, or physicians about patient condition, treatment plans, or appropriate activities.</li><li>
Has a solid understanding of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.</li><li>
Performs other related work as needed.</li></ul>
Competencies:<ul><li>
Research certification (e.g., SoCRA, ACRP, Graham School Clinical Trials Management &amp; Regulatory Compliance).</li><li>
Fundamental working knowledge of clinical research.</li><li>
Knowledge of clinical trials regulatory requirements.</li><li>
Knowledge of patient care fundamentals, including aseptic principles and techniques.</li><li>
Ability to provide direct patient care in a professional and respectful manner.</li><li>
Ability to read medical documents and instruments.</li><li>
Ability to train junior research personnel.</li><li>
Ability to participate in protocol review and clinical trials evaluations.</li><li>
Excellent interpersonal skills.</li><li>
Excellent verbal and written communication.</li><li>
Strong data management skills and attention to detail.</li><li>
Excellent time management and ability to prioritize work assignments.</li><li>
Ability to read, understand, and implement clinical trials protocols.</li><li>
Working knowledge of Good Clinical Practices (GCP).</li><li>
Working knowledge of Microsoft Word, Excel and Adobe Acrobat.</li></ul>
Additional Responsibilities
Education, Experience, or Certifications:
Education:<ul><li>
Bachelors degree preferred.</li></ul>
Experience:<ul><li>
Nursing experience in an acute care or ambulatory setting preferred.</li><li>
Phlebotomy and/or intravenous line placement experience preferred.</li><li>
Clinical research experience preferred.</li><li>
Experience with Epic or other electronic medical records preferred.</li></ul>
Licenses and Certifications:<ul><li>
Current valid Registered Nurse - Illinois license required.</li></ul>
Technical Knowledge or Skills:<ul><li>
Demonstrated ability to access computer programs and use or learn basic computer operations.</li></ul>
Working Conditions and Physical Requirements:<ul><li>
Office, clinic, and recruiting events.</li><li>
Occasional weekend/evening hours for enrollment events at community partner locations.</li><li>
Travel may be required for enrollment events at community partner locations.</li></ul>
Required Documents:<ul><li>
Resume</li><li>
Cover Letter</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
Temporary Staff 
Scheduled Weekly Hours
40 
Drug Test Required 
Yes 
Health Screen Required 
Yes 
Motor Vehicle Record Inquiry Required 
No
Pay Frequency
Hourly 
Pay Rate Type
Hourly 
 
FLSA Status
Non-Exempt 
 
Pay Range
$31.25 - $36.00
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
This position is not eligible for benefits. 
Posting Statement
The University of Chicago is an equal 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>

Temporary Clinical Research Nurse Coordinator, Clinical Trials

Retinal Consultants

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

Ophthalmology Clinical Trial Coordinator

Rush University Medical Center

<div>Location: Chicago, Illinois
Business Unit: Rush Medical Center
Hospital: Rush University Medical Center
Department: Pharmacy Services- Administration
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: $53.73 - $84.63 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 Cancer Center Clinical Trials Pharmacist (CCCTP) is the dedicated pharmacist to support clinical trials within the malignant hematology, medical oncology, gynecologic oncology and stem cell therapy programs. The Pharmacist works with the staff and clinicians in the Cancer Center Clinical Trials Office (CCTO) and participates in the Cancer Center protocol review and monitoring committee (PRMC). Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.
<div>Other information:
 
Required Job Qualifications:
 
<ul><li>Current Registered Pharmacist license in Illinois.
</li><li>Completed a Pharmacy Practice (PGY1) Residency plus two years of hematology/oncology/stem cell transplant experience as a Clinical Pharmacist OR three years of hematology/oncology/stem cell transplant experience as a Clinical Pharmacist, plus: Pass Case Based Evaluation (incorporates standardized evaluation of several patient cases with anonymous external review)
</li><li>Obtain Board Certified Oncology Pharmacist (BCOP) certification within three years of start date.
</li><li>Be an RUMC chemotherapy validated pharmacist and maintain annual competency.
</li><li>Become Willow certified within 1 year of hire; Must maintain certification thereafter.
</li><li>Be able to work effectively with others to provide safe and effective drug therapy.
</li><li>Excellent problem solving skills and the ability to work independently and quickly in responding to and resolving a wide range of problems.
</li><li>Flexible work schedule.
</li><li>Participation and membership in professional societies and organizations is desirable.
</li><li>Excellent verbal and communication skills.
</li><li>Dependable in attendance and job performance.
</li><li>Good organizational and time-management skills.
</li><li>Team player with a positive attitude and work ethic.
</li><li>Ability to use Microsoft Windows, Microsoft Office, DoseEdge, laminar air flow hoods, Epic/Beacon, other computer systems software, telephone, copiers, fax machines, calculator, and other office equipment as necessary Working Conditions.
</li></ul> 
Preferred Job Qualifications:
 
<ul><li>Doctor of Pharmacy (PharmD) Degree. 
</li></ul></div>Responsibilities:
 
1. The Clinical Trials Pharmacist supports patient care research by reviewing protocol proposals, coordinating protocol education, coordinating study drug supplies and assisting investigators with protocols.
 
2. Participates in patient care research as a member of the Institutional Review Board.
 
3. Coordinates the drug supplies and audits for investigational drug protocols.
 
4. Coordinates protocol education and implementation (with investigators and research nurses).
 
5. Coordinates research pharmacy quality assurance and improvement activities.
 
6. Ensures compliance with regulations regarding investigational drug storage and procurement.
 
7. Attends interdisciplinary meetings to assist the respective teams and research nurses with patient enrollment.
 
8. Reviews drug therapy of each protocol to ensure appropriate use, dose, dosage form, regimen and route; minimizes therapeutic duplication and avoids drug allergies and drug interactions while providing cost- effective therapy.
 
9. Provides individual patient/family counseling on clinical trial medication regimens, adherence to medication regimens, and adverse effects of medication regimens to patients/caregivers prior to initiation of clinical trial therapy and documents same in the electronic medical record.
 
10. Prevents, detects, monitors, documents and reports adverse drug reactions and medication errors.
 
11. Reviews Cancer Center clinical trial orders and is available to Nursing staff and Clinical Pharmacists for questions on Cancer Center clinical trial medication orders.
 
12. Acts as the Pharmacy liaison to the Cancer Center and Clinical Trials Office.
 
13. Coordinates pharmacy participation in research related committees for the Cancer Center including: Protocol Review and Monitoring Committee (PRMC) and Institutional Review Board (IRB).
 
14. Provides updates on Cancer Center clinical trials to the respective programs as needed via memos, presentations and one-on-one communications.
 
15. Provides education to the interdisciplinary rounds team members on relevant Cancer Center clinical trials.
 
16. Participates in outcomes-based research and quality improvement initiatives for the Cancer Center.
 
17. Provides updates in Cancer Center Clinical trials to the Department of Pharmacy as needed via memos, presentations and one-on-one communications.
 
18. Assists with development of clinical trial protocol order templates and Epic/Beacon protocol builds. Builds study protocols and study drugs in Willow for Epic use.
 
19. Develops storage and preparation instructions for Cancer Center investigational drugs and commercial drugs in clinical trials, if specific instructions exist.
 
20. Precepts Introductory to Pharmacy Practice (IPPE) students, Advanced Pharmacy Practice Experience (APPE) students, Pharmacy Practice Residents (PGY1) and Specialty Residents (PGY2) on rotation in the Cancer Center clinical trials specialty area.
 
21. Participates in clinical trials drug distribution and order verification support as necessary.
 
22. Works with the Pharmacy Manager and pharmacy informatics staff to improve Cancer Center clinical trial agent workflow and safety.
 
23. Assists in the review of Pharmacy policies impacting Cancer Center clinical trial processes.
 
24. Receives, reviews, and verifies all new patient orders and documents are the same on the respective order form.
 
25. Supervises, coordinates, directs and/or participates in the preparation of sterile intravenous admixtures, dispenses all pharmaceuticals and related supplies and equipment in accordance with federal, state and local laws and standards of practice which govern the profession of pharmacy.
 
26. Processes and checks all medications, supplies and equipment prior to dispensing from the pharmacy; Processes all orders in a timely fashion.
 
27. Maintains pharmacy records in accordance with applicable laws and regulations.
 
28. Maintains clinical skills and knowledge of pharmacotherapy by reviewing the literature and attending in-services, seminars and conferences.
 
29. Accurately administers all procedures involved with the procurement, inventory control, record maintenance and distribution of investigational drugs.
 
30. Monitors drug therapy and communicates relevant findings to other health care professionals who are also responsible for patient care.
 
31. Supervises support personnel in the data entry process, filling and dispensing of prescriptions, proper storage and adequate inventory control of drugs.
 
32. Participates in on-call rotation.
 
33. Participates in orientation/training programs for new personnel and current staff; Participates in the educational activities of pharmacy technicians and serves as a preceptor exposing them to all aspects of pharmacy practice.
 
34. Participates in departmental quality assurance activities.
 
35. Performs marketing support functions as requested.
 
36. Attends department meetings as scheduled.
 
37. Performs within the framework of the RUMC/HDM. L.L.C. policies and procedures.
 
38. Performs other relevant tasks or special projects.
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 Trials Pharmacist

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

Huron Consulting Group

<div>Huron helps its clients drive growth, enhance performance and sustain leadership in the markets they serve. We collaborate with education organizations to develop strategies and implement solutions that enable the transformative change our clients need to own their future. Together, we empower clients to drive innovation, create sustainable funding streams and deliver better student outcomes. 
 
Today, leaders of higher education institutions and academic medical centers are spending too much time reacting to market forces, rather than focusing on the essential priorities that help students, faculty and staff thrive. The most productive path forward requires an intentional approach and innovative thinking, whereby stakeholders across the entire institution rally around a shared vision and embrace the hard work of effecting change. 
 
You&rsquo;ll help our clients to achieve organizational effectiveness, improve student outcomes, implement new technologies and align resources and investments to ensure long-term sustainability. 
 
Join our team as the expert you are now and create your future.
Your passion and expertise in clinical research will make you a key member of Huron&rsquo;s Research Office Team. As a Clinical Research Administrative Specialist II, you&rsquo;ll assist Huron&rsquo;s Research Office team in developing coverage analysis reports, study budgets, study calendars, charge segregation, and other trial documentation required for clinical research studies, including industry, federally sponsored, and locally (investigator) sponsored research. You will also assist in review and feedback for Clinical Research Administrative Specialist I projects and will begin to support client contacts for client specific needs. You&rsquo;ll have the opportunity to expand upon your working knowledge and experience with clinical trial regulation, and to develop strong skills in the variety of service lines Huron&rsquo;s Research Office offers
Required<ul><li>
U.S. work authorization is required</li><li>
Huron requires a bachelor&rsquo;s degree in a field related to this position or equivalent work experience</li><li>
A minimum of 3 years of clinical research administration related experience</li><li>
Experience developing clinical research budgets</li><li>
Experience in coverage analysis</li></ul>
Preferred: ***Clinical Trial budget development &amp; negotiation experience is highly desired***<ul><li>
Clinical Trials Policy and Research Billing Rules Knowledge: Experience in clinical trials policy and other applicable research billing rules. Experience applying the policy to clinical trial protocols for coverage determination.</li><li>
Quality Assurance Expertise: Experience with conducting Quality Assurance reviews, aiming to significantly reduce the QA burden.</li><li>
Medical Coding/Billing Experience: Background in medical coding or billing or degree in Health Information Management.</li><li>
Professional Communication Proficiency: Demonstrated experience interacting with individuals at various levels in an organization and providing timely updates both from an internal and external standpoint.</li><li>
Innovative Problem Solving: Ability to contribute to innovative solutions and process improvements in clinical trial coverage analysis and budgeting.</li><li>
Training and Mentorship: Experience in providing guidance and training to junior staff, fostering a culture of continuous improvement and skill development.</li><li>
Industry Knowledge: Staying abreast of industry trends and regulatory changes to maintain expertise</li></ul><div><div>
Additional Job Description</div></div><div><div><div><div><div><div><div><div><div>
The estimated base salary range for this job is $65,000 - $95,000. The range represents a good faith estimate of the range that Huron reasonably expects to pay for this job at the time of the job posting. The actual salary paid to an individual will vary based on multiple factors, including but not limited to specific skills or certifications, years of experience, market changes, and required travel. This job is also eligible to participate in Huron&rsquo;s annual incentive compensation program, which reflects Huron&rsquo;s pay for performance philosophy. Inclusive of annual incentive compensation opportunity, the total estimated compensation range for this job is $70,200 - $112,100 The job is also eligible to participate in Huron&rsquo;s benefit plans which include medical, dental and vision coverage and other wellness programs. The salary range information provided is in accordance with applicable state and local laws regarding salary transparency that are currently in effect and may be implemented in the future.<div><div>
Additional Job Description</div></div><div><div><div><div><div><div><div><div><div>
#LI-JH1</div></div></div></div></div></div></div></div></div>
#REMOTE</div></div></div></div></div></div></div></div></div><h2 class="jobSectionHeader">
Position Level</h2>
Senior Analyst<h2 class="jobSectionHeader">
Country</h2>
United States of America</div>

Research Admin Specialist II-Clinical Trial Budgets, US Remote

Explore 173+ Clinical trials coordinator in Chicago this May. Find roles across top companies and apply now to boost your career.