Clinical Associates - Neonatology
Clinical research coordinator job in Chicago, IL
Salary Range: $160,000-$190,000 per year
The University of Chicago's Department of Pediatrics, Section of Neonatology, is seeking full-time general pediatricians to join our multidisciplinary care team at the University of Chicago Comer Children's Hospital NICU as Clinical Associates with renewable terms of up to three years.
Appointees will provide neonatal services at one or more level II nurseries in the University of Chicago Medicine system. These positions do not require teaching or scholarly activity. Compensation is dependent upon qualifications. These positions are benefits-eligible. 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.
Appointees will collaborate with a dynamic team of neonatologists, neonatal nurse practitioners, pediatric residents, nutritionists, and neonatal pharmacists, providing care under the supervision of the attending neonatologist. Responsibilities include daily patient care activities such as pre-rounding, presenting patients, order writing, addressing clinical problems, and communicating with parents and consultants. Following skills evaluation and, if necessary, additional training and support, appointees will perform standard neonatal procedures, attend high-risk deliveries, and perform neonatal resuscitations.
At our level II nurseries, appointees will attend deliveries, perform neonatal resuscitations, stabilize infants for transport, and manage infants whose acuity allows them to remain at their birth hospital.
Prior to the start of employment, qualified applicants must: 1) have a MD degree or equivalent, 2) have completed an ACGME-approved pediatric residency, 3) be board certified/eligible in general pediatrics, and 4) have or be eligible for permanent State of Illinois medical licensure.
We especially welcome applicants with experience equivalent to one year of post-graduate work in a Level II NICU or one of higher acuity.
To be considered, interested individuals must apply through The University of Chicago's Academic Recruitment job board, which uses Interfolio to accept applications: ************************************ Applicants must upload a CV and cover letter. Review of applications will continue until the positions are filled.
For instructions on the Interfolio application process, please visit ******************************
Equal Employment Opportunity 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 ************ or emailequalopportunity@uchicago.eduwith their request.
Clinical Research Associate
Clinical research coordinator job in Chicago, IL
Department: MED-Impact Institute Salary/Grade: RES/ Hiring: HIV Implementation Science Coordination Initiative Project Director (Clinical Research Associate), Institute for Sexual and Gender Minority Health and Wellbeing Program Description: Implementation science (IS) is a relatively new field with exciting opportunities for growth and innovation focused on methods to promote the adoption and integration of evidence-based practices, interventions, and policies into routine healthcare and public health settings. The HIV Implementation Science Coordination Initiative (ISCI) is the national coordinating and technical support center for Centers for AIDS Research/AIDS Research Centers research-practice partnerships funded as part of the Ending the HIV Epidemic plan. ISCI provides high-quality IS coordination, consultation and data management for NIH-funded Ending the HIV Epidemic (EHE) implementation research teams and creates opportunities to share generalizable knowledge to help end the HIV epidemic in the United States. ICI identifies and disseminates best practices in HIV implementation research, while providing training, and resources to support academic researchers and practice-based partners.
Position Description:
The Project Director will lead project and personnel management for ISCI, overseeing complex multi-investigator projects across multiple institutions and supervising several research staff. This role involves developing and managing project plans with defined timelines, deliverables, and resources, while identifying opportunities for growth, assessing potential impacts, and collaborating with cross-functional teams to implement innovative solutions. The ideal candidate is an experienced leader with expertise in project management of complex, multi-investigator projects across multiple institutions, experience supervising multiple staff, strong written and oral communication skills, effective time management capabilities, and ability to work independently.
The average target hiring range for this position will be between $80,000 - $95,000 per year. Final offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.
Duties and Responsibilities:
Project and Personnel Management
* Develops and implements comprehensive project plans, including timelines and deliverables.
* Assists in the development and execution of new initiatives, leads strategic planning efforts to ensure alignment with project goals and objectives.
* Identifies opportunities for project growth, assesses potential impacts, and collaborates with cross-functional teams to implement innovative solutions.
* Leads and coordinates multiple teams, ensuring effective communication and collaboration across the project.
* Trains, directs, assigns duties to, and supervises research staff and/or fellows.
* Allocates and manages project resources, including personnel, budget, and materials, to ensure optimal project performance.
* Acts as the primary contact for stakeholders (sponsoring agencies and collaborators), providing regular updates on project progress and addressing any issues or concerns.
* Maintains project documentation, including project plans, progress reports, and final reports.
* Ensures that all project activities adhere to quality standards and regulatory requirements.
* Evaluates project outcomes and processes to identify areas for improvement and implement best practices.
Administration
* Analyzes, evaluates and interprets data to determine relevance to research.
* Prepares results and may lead and co-author scientific papers for presentation and publication and disseminate information via seminars, lectures, etc.
* Creates data for use in grant submission and develops new proposals for research including obtaining financial support.
* Ensures that all study documents associated with current local, state, and federal regulatory guidelines, requirements, laws and research protocols are completed in a timely manner.
Finance
* May create and/or manage research study budget which may include deciding on and approving expenditures of funds based on budget.
* Monitors accounts.
* Ensures appropriate allocation and compliance.
Miscellaneous
* Performs other duties as assigned.
Position Details: This is a full-time position based on the Chicago campus of Northwestern University.
Minimum Qualifications (Education, experience, and any other certifications or clearances)
* Master's or doctoral degree in social/behavioral science (e.g., psychology, sociology, anthropology), public health, humanities, or related field
* At least 5 years of experience with managing complex projects that involve multiple principal investigators, sites, institutions, and/or public health practice settings.
* Experience in project management and supervising multiple staff is required.
* Experience using project management software.
* Experience using Microsoft Office 365 and basic computer programs (e.g., Teams, Sharepoint, OneNote, Word, Excel, PowerPoint, Adobe, Google, etc.)
* Must complete NU's IRB CITI training before interacting with any participants and must re-certify every 3 years.
Minimum Competencies (Skills, knowledge, and abilities)
* Strong project coordination skills and the ability to prioritize tasks.
* Demonstrated attention to detail and ability to adhere to instructions/procedures.
* Good communication skills; demonstrated effective spoken and written communication.
* Good time management skills; efficient and resourceful in problem-solving.
* Demonstrated ability to take ownership of the work, possessing initiative, good follow-through; ability to work without supervision.
Preferred Competencies (Skills, knowledge, and abilities)
* Familiarity with implementation science concepts (e.g., models and frameworks, determinants, outcomes, strategies, study designs).
* Familiarity with HIV prevention and care research
To apply: Applicants should email application materials to ********************* with the subject line "ISCI Project Director." Applications should include a CV and cover letter explaining fit with this position; relevant work or educational experiences, including experiences with research topic areas, and the names of two references who will be contacted only for finalists. Consideration of applications will begin immediately and continue until the position is filled.
Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.
Easy ApplySenior Clinical Research Associate (CRA)
Clinical research coordinator job in Chicago, IL
The Sr CRA will be responsible for monitoring clinical studies at the site level ensuring adherence to protocols, timelines, ICH/GCP guidelines, and federal regulations. The Sr CRA will perform site qualification visits, study start-up activities, protocol implementation, on site monitoring, and close out activities as assigned and in accordance with Xeris SOPs and related study monitoring plans.
**Responsibilities**
- Serves as a CRA to conduct and document qualification, study initiation, interim monitoring, and close-out visits at investigator sites in accordance with the monitoring plan.
- Monitors data, on site and/or remotely (as needed), with a focus on participant safety, data integrity and regulatory compliance. Ensures the validity, correctness, and completeness of clinical data.
- Ensures data accuracy, accountability and documentation through review of case report forms, source documents, medical records, and the Investigator Site Files (ISF).
- Conducts Investigational Product (IP) review and accountability on site.
- Serves as point of escalation for clinical site management and investigator sites. Liaises with the in-house CRA interacting with investigator sites and responsible to support effective communications and resolution of issues.
- Maintains routine contact with investigator sites between routine on site monitoring visits.
- Identifies, assesses, and resolves issues related to site performance, program risks, data inconsistencies/deviations, quality and compliance. Re-educates investigator sites as required, escalates issues, and ensures implementation of corrective actions.
- Ensures all essential documents are complete and in place, filed to the study electronic trial master file (eTMF) and inspection ready. Participates in eTMF QC activities and ensures consistency between ISF and eTMF.
- Manages query resolution with investigator sites and data management operations.
- Supports centralized risk-based monitoring oversight activities as assigned.
- May support the Study Manager to formulate regional monitoring strategy, forecasting of site visits and/or overall clinical monitoring plans.
- Provides oversight of CRO activities related to monitoring (when outsourced); may co-monitor with CRO or contracted CRAs.
- Supports the maintenance of documentation to clinical systems (Clinical Trial Management Systems [CTMS], electronic data capture [EDC], Interactive Response Technology [IRT], etc.) and related supporting documents (manuals, completion guidelines, etc.) in collaboration with other study team members and/or external vendors as applicable.
- May support development and revision of monitoring SOPs, processes, forms, templates, tools, etc. with aim of continual improvement and efficiency.
- Supports audits/inspections/inspection readiness activities through collaboration with relevant clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA or external regulatory agencies as applicable.
- Performs other tasks or responsibilities as assigned.
**Qualifications**
- Bachelor's degree (B.A./B.S.) or equivalent in life sciences or related discipline.
- 6+ years' experience as a Clinical Research Associate.
- Extensive knowledge of trial oversight activities, GCP/ICH and federal regulations, IRB/EC and Investigator responsibilities.
- Familiarity with clinical trial systems (i.e. CTMS, EDC, eTMF, etc.).
- Strong computer skills, including a high level of proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, etc.).
- Ability to work independently and as part of a team.
-Competencies: Multi-Tasking, Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Strong Written and Verbal Communications.
- Working Conditions: If employee is Chicago based - this is a hybrid role based in Xeris' Chicago office and requires a minimum of three days per week in the office as feasible when not traveling. On-site requirements may change at management's discretion. Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Travel up to 75%.
_The level of the position will be determined based on the selected candidate's qualifications and experience._
\#LI-HYBRID
_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._
_The anticipated base salary range for this position is $80,000 - $140,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._
_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._
**Job Locations** _US-IL-Chicago_
**Title** _Senior Clinical Research Associate (CRA)_
**ID** _2025-2205_
**Category** _Clinical Development_
**Type** _Full-Time_
Clinical Research Scientist Interventional Solutions
Clinical research coordinator job in Chicago, IL
Are you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
**Job Description**
**Responsibilities**
+ Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities.
+ Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions).
+ Support adoption of new technology or clinical applications through advocacy and evidence.
+ Participate in customer presentations regarding use of Interventional products for institution research purposes.
+ Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs.
+ Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations
+ Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns.
+ Grow technology leadership mindshare through joint scientific presentations and publications.
+ Install/upgrade research equipment and software & prototypes
+ Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures
+ Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products.
+ Study new technology concepts and leverage expertise to move initiatives forward.
Note:
+ No sponsorship available for this role now or in the future to work in the United States..
**Qualifications**
+ PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field.
+ 3+ years of experience in Interventional healthcare industry or research.
+ Knowledge of Interventional procedures, anatomies, clinical practice.
+ Excellent written and verbal communication skills.
+ Excellent customer relationship management and collaboration skills.
+ Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas.
+ Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task.
+ Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams.
+ Able to individually lead complex projects with autonomy, rigor, drive & competence
+ Ability to travel (
+ Quality, Compliance, and Continuous Improvement focus
**Desired Characteristics**
+ 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics.
+ Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department)
+ Demonstrated record of innovation and development.
+ History of publications, clinical/non-clinical experiments, knowledge in statistics
+ Programming / Image processing experience
+ Experience with academic and/or clinical research collaborations
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity.
Our **total rewards** are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
\#LI-BR3
\#LI-Remote
We will not sponsor individuals for employment visas, now or in the future, for this job opening.
For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
**Additional Information**
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
**Relocation Assistance Provided:** No
Clinical Research Associate (CRA) I
Clinical research coordinator job in North Chicago, IL
+ Name of Functional Area/Department: Clinical Pharmacology & Pharmacometrics Research Unit + Open 24/7, will work 8-hour shifts. There is no guarantee of hours. Some weeks may have no shifts whereas others may have 4 or 5. Shift options: day shift for training, Schedule comes out every 2 weeks, hours needed are weekdays, 7am - 2 pm and up to two Saturdays a month.
**Minimum Education Required:**
+ High School Diploma or equivalent
**Preferred Education:**
+ **Clinical Medical Assistant, EMT, Paramedic** , military medic with recent clinical experience, or higher
**Minimum Experience Required:**
+ 1-2 years of work experience in a clinical or research environment, or in a patient care setting; and
+ 1-2 years of work experience in a role with **phlebotomy responsibilities**
**Major Job Responsibilities:**
+ Review protocols and comply with study-specific activities
+ Communicates in an appropriate and professional manner with study subjects and unit personnel.
+ Maintain accurate and complete source data.
+ Perform study protocol related activities, i.e. phlebotomy, sample processing, **ECG collection** , vital signs, height/weight, etc., as assigned.
+ Maintain safety and confidentiality of study subjects throughout the study.
+ Understands and complies with SOPs, FDA regulations, and basic GCP requirements.
**Top 5 skills/requirements this person is required**
+ Required Skill 1: Phlebotomy
+ Required Skill 2: Lab work
+ Required Skill 3: ECG collection
+ Required Skill 4: Vital signs collection
+ Required Skill 5: clinical and/or hospital setting.
**About US Tech Solutions:**
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** (*********************************** .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Clinical Research Associate
Clinical research coordinator job in Downers Grove, IL
CRA II or Senior CRA (Home-based in U.S.) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Senior Clinical Research Associate or Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
**What you will be doing**
+ Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
+ Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
+ Collaborating with investigators and site staff to facilitate smooth study conduct.
+ Performing data review and resolution of queries to maintain high-quality clinical data.
+ Contributing to the preparation and review of study documentation, including protocols and clinical study reports
**Your profile**
+ Bachelor's degree in a scientific or healthcare-related field.
+ Minimum of 1 year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior Clinical Research Associate.
+ In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
+ Strong organizational and communication skills, with attention to detail.
+ Ability to work independently and collaboratively in a fast-paced environment.
+ Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
\#LI-MM2
\#LI-Remote
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site (************************************* to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (******************************************************
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here (****************************************************** to apply
Clinical Research Associate
Clinical research coordinator job in Downers Grove, IL
CRA II or Senior CRA (Home-based in U.S.)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a Senior Clinical Research Associate or Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
Performing data review and resolution of queries to maintain high-quality clinical data.
Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
Bachelor's degree in a scientific or healthcare-related field.
Minimum of 1 year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior Clinical Research Associate.
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
Strong organizational and communication skills, with attention to detail.
Ability to work independently and collaboratively in a fast-paced environment.
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
#LI-MM2
#LI-Remote
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
Auto-ApplyClinical Research Associate (West Coast)
Clinical research coordinator job in Chicago, IL
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
Position Overview
This position is responsible for executing, managing and conducting projects associated with the company clinical study plans. The Contract Clinical Research Associate (CCRA) is responsible for site management deliverables on assigned protocols and may support other CRAs on the team.
This position requires the CRA to be based in either Chicago, IL or Dallas, TX and be fluent in Spanish.
Essential Duties
Include, but are not limited to, the following:
Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies.
Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships.
Serve as a point of contact for investigators and site staff. Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates.
Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables.
Conduct thorough site qualifications visits. Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams.
Conduct efficient and comprehensive site initiation visits. Ensure all assigned site staff are trained appropriately, have access to the required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements.
Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs. Maintain a flexible monitoring schedule (as appropriate) and assist in co-monitoring or monitoring support of clinical sites/studies.
Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements). Ensure all clinical site staff actively participating in the study are appropriately trained. Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team.
Conduct device/product accountability responsibilities at clinical sites; Identify, clearly communicate and document issues to the clinical site and project team. Assist clinical site in resolving issues, if appropriate.
Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.). Communicate status of Site management activities on a routine basis to the Clinical Project team and management.
Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and CRA team members.
Implement and execute the clinical study Monitoring Plan to ensure compliance with the plan and all assigned tasks throughout the study.
Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members.
Communicate project specific information to/from trial sites through teleconferences, newsletters, etc.
Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis.
Document monitoring activities in monitoring visit reports and follow-up letters.
Communicate serious issues to appropriate parties, in a timely manner.
Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed.
Participate in Investigator Meetings, and other study trainings and meetings as required.
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
Support and comply with the company's Quality Management System policies and procedures.
Maintain regular and reliable attendance.
Ability to act with an inclusion mindset and model these behaviors for the organization.
Ability to work designated schedule.
Ability to work nights and/or weekends, as needed.
Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
Ability to work on a computer and phone simultaneously.
Ability to use a telephone through a headset.
Ability to travel 50% of working time away from work location may include overnight/weekend travel.
Minimum Qualifications
Bachelor's Degree in field as outlined in essential duties or
Associate degree with a minimum of 6 years of monitoring experience or equivalent experience.
Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience.
4+ years clinical research monitoring experience or equivalent experience.
No other results from the Motor Vehicle Report (MVR) check that exposes Exact Sciences to what Exact Sciences deems to be an unacceptable level of liability.
Proficiency in data management, including progressive experience in data entry, validation, and cleaning. Familiarity with Electronic Data Capture (EDC) systems.
Effective communication skills and ability to collaborate with investigators, site staff, and team members. Demonstrated ability to work well within a team and convey information effectively.
Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements. Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices.
Meticulousness with a focus on accuracy and precision in all tasks and activities.
Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and close-out visits. Proficiency in monitoring plans, protocol adherence, and GCP guidelines. Conducting source data verification, resolving queries, and ensuring site compliance and data accuracy.
Demonstrated ability to perform the essential duties of the position with or without accommodation.
Authorization to work in the United States without sponsorship.
Preferred Qualifications
Experience or knowledge in In Vitro Diagnostics (IVD).
Certifications related to clinical research.
Working knowledge of the FDA submission process including IDE, PMA, and 510(k).
Strong on-site monitoring experience in clinical trials, including:
Site initiation.
Routine monitoring visits.
Site closeout.
Knowledge of electronic trial master file (eTMF) systems and document management processes.
This position requires the CRA to be based in either Chicago, IL or Dallas, TX and be fluent in Spanish.
#LI-JH1
#LI-REMOTE
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
Auto-ApplyClinical Research Associate II
Clinical research coordinator job in Chicago, IL
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Travel Clinical Research Coordinator
Clinical research coordinator job in Chicago, IL
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The Travel Clinical Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access Research to the community, Sponsors, CROs, and study participants and their family members.
The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations.
How You'll Make An Impact
* Study Preparation:
* Ability to understand and follow institutional SOPs
* Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.
* Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct
* Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff
* Assist with planning and creation of appropriate recruitment and marketing materials
* Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc.
* Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies
* Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives
* Assist in the creation or review of protocol specific source documents
* Determine facility, equipment and outsource vendor requirements and availability
* Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance
* Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks
* Study Management:
* Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety.
* Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies
* Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records
* Collect and evaluate concomitant medications
* Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual.
* Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings
* Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave
* Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
* Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access Research team in an ongoing fashion
* Maintain effective relationships with study participants and other Care Access Research personnel
* Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management
* Strong and clear communication skills, both verbally and in writing
* Accept accountability for actions and function independently
* Patient Coordination:
* Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
* Obtain informed consent per Care Access Research SOP and document process when revised ICF discussed with patient during course of the trial
* Administer delegated study questionnaires, where appropriate.
* Collect and evaluate medical records with the support of medically qualified members of the study team.
* Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol
* Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
* Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion
* Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs)
* Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol
* Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround
* Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance.
* Monitor patient progress on study medication
* Documentation:
* Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP
* Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion.
* Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart
* Accurately transcribe data to CRF or EDC.
* Resolve data management queries and correct source data as needed
* Record protocol exemptions and deviations as appropriate with sponsor.
* Complete Note(s)-to-File for patient chart and regulatory filing if necessary
* Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing
* Maintain copies of patient-specific correspondence in source charts
* Assist regulatory personnel with completion of continuing/final review reports
* Perform other duties as assigned.
The Expertise Required
* Excellent working knowledge of clinical trials, medicine and research terminology
* Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+
* Ability to communicate and work effectively with a diverse team of professionals
* Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
* Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel.
* Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc.
* Critical thinker and problem solver
* Friendly, outgoing personality; maintain a positive attitude under pressure
* High level of self-motivation and energy
* Excellent professional writing and communication skills
* Ability to work independently in a fast-paced environment with minimal supervision
Certifications/Licenses, Education, and Experience:
* BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred
* RN or LPN preferred
* Research Professional Certification- CRCC or exam eligibility preferred
* A minimum of 3 to 4 years Clinical Research experience
* A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred.
How We Work Together
* Extensive travel required. Candidates must be willing to travel 75% of the time nationwide. Duties may require travel for a two-week stretch, followed by one week home. Frequency and length of travel may depend on the length and location of study.
The expected salary range for this role is $70,000-$100,000 USD per year. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off.
Benefits & Perks (US Full Time Employees Only)
* Paid Time Off (PTO) and Company Paid Holidays
* 100% Employer paid medical, dental, and vision insurance plan options
* Health Savings Account and Flexible Spending Accounts
* Bi-weekly HSA employer contribution
* Company paid Short-Term Disability and Long-Term Disability
* 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
Senior/Lead Clinical Research Coordinator
Clinical research coordinator job in Chicago, IL
Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.
We are actively hiring Senior Clinical Research Coordinators at our Ravenswood, Chicago, IL location!
The Senior Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction.
Shift: Monday-Friday, 8 AM - 5 PM
Location: 1945 W Wilson Ave, Suite 6104, Chicago, IL 60640
Compensation: $35/hr with flexibility depending on experience
Benefits: Health, dental, and vision insurance plans, 401(k) with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays.
RESPONSIBILITIES
The Senior Clinical Research Coordinator (Sr CRC) will act as the lead CRC for a variety of assigned trials.
Executes study protocol procedures in a detailed, organized, and professional manner.
Performs human specimen lab draws and processing, and packages specimen shipments.
Creates and completes study source documents and adverse event reporting on an e-source system.
Maintains study-specific files and supplies.
Communicate with the Study Sponsor/CRO regarding study-specific questions.
Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits.
Additional duties as assigned by management.
QUALIFICATIONS
Bachelor's degree preferred but not required
Phlebotomy experience is required; EKG or other patient labs/processes preferred
5+ years of experience as a Clinical Research Coordinator
Familiar with e-source reporting via an electronic platform
A clear understanding of ICH, FDA, and GCP regulations
Impeccable organizational skills and attention to detail
Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources
An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven
High-level critical thinking skills
Working knowledge of medical terminology and lab collection/processing/storage procedures
Proficiency with computers and Microsoft Office Suite
Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others!
Flourish Research is where clinical trials thrive.
Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.
At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality.
Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect.
Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!
It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
Auto-ApplyClinical Research Associate (CRA) - A
Clinical research coordinator job in Lake Forest, IL
**Title:** Clinical Research Associate (CRA) **Duration:** 12 Months **Remote Role (Occasional travel)** **Pay Range :** $25/hr to $29/hr (On W2) We are looking for a " **Clinical Research Associate (CRA)"** to join one of our Fortune 500 clients.
**Job Summary:**
+ Conduct site qualification, initiation, monitoring, and close-out visits
+ Ensure compliance with protocols, GCP, and regulatory requirements
+ Perform source document verification and data query resolution
+ Support start-up tasks such as protocol development and site contracts
+ Maintain study documentation and monitor investigational product inventory
+ Prepare monitoring visit reports and follow-up letters
**Qualifications:**
+ Bachelor's degree in Life Sciences or related field (Medical Technology preferred)
+ 2-4 years of clinical research experience, including site monitoring
+ Strong understanding of FDA regulations and GCP
+ Experience with medical devices or in vitro diagnostics (IVDs) preferred
+ Excellent communication, organizational, and time management skills
+ Proficient in Microsoft Office Suite
**We are looking for the candidate who are eligible to work with any employers without sponsorship** .
If you're interested, please click **"Apply"** button
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.
Study Coordinator
Clinical research coordinator job in Tinley Park, IL
Job DescriptionAbout Hematogenix
Want a job with greater meaning and higher purpose? Every day Hematogenix employees are warriors fighting a noble and global war on cancer. Helping patients every day, and helping partners every day - with our diagnostic and research services.
Hematogenix is looking for talented and highly motivated individuals to join our team. We offer a competitive benefit package and career development opportunities to help you achieve your highest professional and personal goals. We are eager to show you all we have to offer and how you can grow with us.
Hematogenix is a specialized contract research organization and clinical laboratory with a global presence. Our team of board-certified clinical, anatomic and research pathologists work in conjunction with top scientists from around the world to provide quality testing, consultation, and guidance for all aspects of the company's pharma and diagnostic services.
Job Purpose:
The Clinical Study Coordinator supports the successful delivery of clinical trial projects via operational/day-to-day management of workflows. Deliver excellent customer service to project stakeholders (e.g., clients, clinical sites).
*Please note that this position requires you to be onsite at our Illinois, USA location.
Accountabilities/Work Activities:
Study Initiation
Possess strong working knowledge of company capability's and how it typically aligns with clients' objectives and timelines.
Comfortable developing and maintaining relationships with various project stakeholders where needed (external and internal)
Planning & Design
Contribute, when necessary, operational insights that will impact project scope.
Assist the Project Managers with creation of study specific laboratory binders and regulatory documents.
Executing
Attend in-house initiation meetings with all project personnel in order to understand individual contributions of all, as well as overall study objectives and timelines.
Provide guidance to Pharma Accessioning Team regarding query generation.
Create and send clearly written data clarification messages to ensure outstanding queries are resolved in a timely fashion according to Communication and Escalation Plan established with each Sponsor.
Maintain study tracking spreadsheets/documents in real time if applicable.
Communicate effectively (verbal and written) when interacting with external stakeholders (e.g., CRAs, SCs, PIs, etc.)
Interact effectively with all in-house project personnel and provide clear communication on status of cases (query resolution) or specific requests (e.g., expedited testing requests
Perform data entry if needed and/or manage data entry needs of projects to ensure daily/weekly completion occurs.
Process sample repatriations and maintain associated documentation.
Monitoring & Controlling
Participate in regular internal meetings with Project Manager to feed in views of project personnel, outline operational challenges, and learn of wider project progress.
Participate in regular conference calls with clients.
Provide support to Project Manager during client monitoring visits.
Ensure project supplies and day-to-day resources are always appropriately used in an effort to reduce waste and increase efficiency.
Study Closing
Contribute to internal project closing meetings in order to share best practice.
Provide QC support to Project Manager during close out visits.
Experience and Education
Bachelor of Science degree or similar degree related to the role
1-2 years' experience in Clinical Laboratory Science
Skills and Qualifications
Knowledge of GCP/CAP/CLIA and global clinical research industry
Must be able to communicate effectively and persuasively, both verbally and in writing, with all levels of in-house Hematogenix personnel and other project stakeholders (e.g., CRAs, site officials)
Working experience with laboratory information systems
Personal computer skills (Microsoft Word, Excel, Power Point, etc.)
Ability to ambulate throughout the office and laboratory.
Benefits we Offer:
Medical
Dental
Vison
Life
401k
PTO
Competitive Salary
Contact Information:
********************; *******************
Hematogenix provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Easy ApplyClinical Research Coordinator Lead
Clinical research coordinator job in Chicago, IL
Business Unit: Rush Medical Center Hospital: Rush University Medical Center Department: Pediatric Neurology Research 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 (*****************************************************
Pay Range: $32.00 - $46.44 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'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 Lead Clinical Research Coordinator provides advanced coordination, may lead project-driven research and operational leadership for a portfolio of clinical trials. This role supports departmental oversight by supervising CRC I-III staff, resolving operational barriers, liaising with sponsors and regulatory partners, and ensuring standardization and quality across clinical research processes. The Lead CRC may serve as an interim manager, supports onboarding and training efforts, and contributes to departmental planning, audit response, and portfolio coordination. This position exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.
Required Job Qualifications:
Education:
* Bachelor's degree
Experience:
* 3+ years of progressive clinical research coordination
* Independent site management experience
OR
Experience (in lieu of a degree)
5 years of experience coordinating clinical trials of increasing complexity, including mentoring junior coordinators and serving as the primary point of contact for study teams.
Knowledge, Skills, & Abilities:
* Regulatory Knowledge - Applies GCP, FDA, NIH, and IRB rules across multiple studies; supports staff in understanding and applying complex regulatory requirements.
* Regulatory Compliance - Tracks team-wide compliance, identifies gaps, and corrects reporting or documentation issues before they escalate.
* Project & Time Management - Leads timelines, task tracking, and team coordination for multiple studies; adjusts resources to meet study goals.
* Problem-Solving & Critical Thinking - Uses good judgment to solve study and team-level problems; handles complex challenges and makes protocol-aligned decisions.
* Detail & Organization - Reviews and standardizes documentation across study teams; ensures records are accurate, complete, and audit-ready.
* Participant & Vendor Interaction - Maintains respectful, professional communication with participants, sponsors, vendors, and partners; ensures team alignment with protocols.
* Communication Skills - Communicates clearly with staff, sponsors, CROs, and auditors; prepares summaries, updates, and responses as needed.
* Teamwork & Supervision - Supports CRC I-III staff by providing feedback, resolving questions, and helping the team meet performance expectations.
* Flexibility - Adjusts work schedule to support high-priority study tasks, staff supervision, or sponsor visits.
* Travel Readiness - Able to travel locally or regionally to support site visits, sponsor meetings, or team supervision.
Preferred Job Qualifications:
Education:
* Master's degree or equivalent
Experience:
* Managing NIH, pharmaceutical, or device clinical trials
* Strong background in research coordination
* Prior supervising or mentoring research staff
Certifications:
* Relevant certification strongly preferred (Certified Clinical Research Professionals (CCRP),
* Certified Clinical Research Associate (CCRA),
* Certified Clinical Research Coordinator (CCRC), OR
* Certified IRB Professional (CIP)
Responsibilities:
1. Oversees participant enrollment efforts across multiple studies and study teams, ensuring consistency in eligibility screening, consent documentation, scheduling, and follow-up.
2. Oversees CRC data entry practices and provides real-time guidance to ensure that data entered into CRFs and EDC systems is complete, accurate, and source-verified.
3. Coordinates department-wide protocol submissions and amendments; serves as liaison to IRB and regulatory offices for active and upcoming studies.
4. Reviews documentation across studies and staff for completeness, accuracy, and readiness for sponsor/regulatory audit; standardizes source documentation practices within the department.
5. Leads department-wide source documentation and data entry oversight by setting expectations for 100% source verification, monitoring staff adherence, and implementing corrective workflows to ensure complete, accurate, and audit-ready data across all studies.
6. Advises CRC staff on appropriate specimen handling workflows across trials; resolves process gaps affecting specimen integrity or chain-of-custody.
7. Provides technical oversight of CRC-conducted assessments, ensuring training compliance, protocol accuracy, and consistent participant experience across study teams.
8. Serves as lead departmental liaison with sponsors, CROs, regulatory bodies, and internal stakeholders; addresses performance concerns, clarification needs, and documentation queries.
9. Leads team and department audit preparation; coordinates internal monitoring, standardizes documentation practices, and ensures timely implementation of corrective action plans.
10. Reviews safety event documentation across studies; provides coaching and follow-up with CRCs to ensure timely and appropriate AE/SAE and deviation reporting.
11. Implements department-level process improvements in coordination with Research Manager; identifies training gaps and operational inefficiencies for intervention.
12. Directly supervises CRC I-III staff, including onboarding, delegation of tasks, performance coaching, and annual evaluations. Supports team cohesion and role progression through mentorship.
13. Supports Research Manager by coordinating portfolio-level study oversight, managing workload distribution, and contributing to feasibility, resourcing, and departmental planning conversations.
14. Leads the development and execution of comprehensive project plans for clinical research studies, including timeline management, resource allocation, budget oversight, and coordination among cross-functional teams to ensure adherence to study protocols and regulatory requirements.
15. 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.
Clinical Research Coordinator II
Clinical research coordinator job in Chicago, IL
Details Job Title CLINICAL RESEARCH COORDINATOR II Position Number 8150021 Job Category University Staff Job Type Full-Time FLSA Status Non-Exempt Campus Maywood-Health Sciences Campus Department Name HEMATOLOGY ONCOLOGY Location Code HEMATOLOGY - ONCOLOGY (06508A) Is this split and/or fully grant funded? Yes Duties and Responsibilities
The Clinical Research Coordinator II is responsible for the overall management and implementation of an assigned set of multiple research protocols assuring efficiency and regulatory compliance. These studies will be conducted at the Loyola University Medical Center and satellites. He/she will work as part of a clinical trials research team and report to various Principal Investigators conducting clinical research in coordination with Clinical Research Nurse. Responsibilities include assisting in the preparation of initial study documents for IRB submission in compliance with all local, state and federal regulations; advise the IRB of amendment changes to the protocol and complete annual protocol renewals. Recruit, screen, assist in the informed consent process and enroll subjects in accordance with good clinical practice guidelines. Collect, record and maintain complete data files using good clinical practice in accordance to HIPAA regulations. He/she participates in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies. The successful candidate will interact with subjects by scheduling diagnostic and research evaluation visits, perform study related assessments including collection of blood samples, processing and shipment. Maintain drug accountability, adequate study supplies and equipment. The coordinator will oversee subject compliance to the study protocol, obtain information from the study subject regarding any changes in their medications or adverse events and promptly report the findings to physicians for documentation in the subject's medical record. Report all serious adverse events promptly to investigators, sponsors and the IRB. Protect the rights, safety and well-being of human subjects involved in the clinical trials.
Responsibilities of the CRC II include all the duties and responsibilities if CRC I, as well as the following:
Coordination responsibilities
* Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines.
* Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
* In collaboration with the PI & RN, incorporates clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria.
* Coordinate collection of study specimens and processing.
* Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
* Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed.
* Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
* Ensure adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
* Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
* Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
* Participate in monitor visits and regulatory audits.
Regulatory responsibilities:
* Processes local IRB submissions to include new research projects, amendments, adverse events and study terminations.
Minimum Education and/or Work Experience
Bachelors Degree OR equivalent training acquired via work experience or education and 2-5 years of previous job-related experience
Qualifications
* Ability to follow oral and written instructions and established procedures
* May require use of centrifuge, make slides for labs, ECG's to be performed and transmitted.
* Medication administration
Certificates/Credentials/Licenses
SOCRA CCRP or ACRP certification OR equivalent CRO industry experience with certification obtained within 1 year of hire.
Computer Skills
Should have basic knowledge in Excel, WORD, EPIC (EMR for the hospital),and Internet based data submission.
Supervisory Responsibilities No Required operation of university owned vehicles No Does this position require direct animal or patient contact? No Physical Demands Repetitive Motions Working Conditions None Open Date 05/07/2025 Close Date Position Maximum Salary or Hourly Rate 26.00/hour Position Minimum Salary or Hourly Rate 28.00/hour Special Instructions to Applicants
As a Jesuit, Catholic institution of higher education, we seek candidates who will contribute to our strategic plan to deliver a Transformative Education in the Jesuit tradition. To learn more about Loyola University Chicago's mission, candidates should consult our website at ********************* For information about the university's focus on transformative education, they should consult our website at *****************************
About Loyola University Chicago
Founded in 1870, Loyola University Chicago is one of the nation's largest Jesuit, Catholic universities, recognized for its academic excellence, commitment to community engagement, and leadership in sustainability. A Carnegie R1 research institution, Loyola leverages its status as one of an elite group of universities with the highest level of research activity to advance knowledge that serves communities and creates global impact. With 15 schools, colleges, and institutes-including Business, Law, Medicine, Nursing, and Health Sciences-Loyola operates three primary campuses in the greater Chicago area and one in Rome, Italy, that provide students a transformative, globally connected learning experience. Consistently ranked among the nation's top universities by U.S. News & World Report, Loyola is a STARS Gold-rated institution that is ranked as one of the country's most sustainable campuses by The Princeton Review and has earned distinctions from AmeriCorps and the Carnegie Foundation for its longstanding record of service and community engagement. Guided by its Jesuit mission and commitment to caring for the whole person, Loyola educates ethical leaders who think critically, act with purpose, and strive to create a more just and sustainable world.
Loyola University Chicago strives to be an employer of choice by offering its staff and faculty a wide array of affordable, comprehensive, and competitive benefits. To view our benefits in detail, click here.
Loyola adheres to all applicable federal, state, and/or local civil rights laws and regulations prohibiting discrimination in private institutions of higher education. Please see the University's Nondiscrimination Policy.
Clinical Trial Coordinator
Clinical research coordinator job in Vernon Hills, IL
Clinical Trial Coordinator Duration : 12+ Months Contract Start Time : 8:00 AM End Time : 5:00 PM Total Hours/week : 40.00 Experience in office documentation filing preferred. · Strong organizational and interpersonal skills.
· Practical, detail oriented, flexible and dedicated team player that is capable of working independently.
· Able to compile brief, coherent, professional documentation and correspondence.
· Working Knowledge of Microsoft Office.
EXPERIENCE PREFERRED
- data entry, knowledge of administration of clinical trials
DESCRIPTION OF JOB RESPONSIBILITIES:
Documentation Management:
- Scanning, copying, and filing clinical study documentation into eTMF or equivalent documentation tracking and storage system
- Storage and archiving of study documents for long-term storage Administrative support of clinical trials:
- Review of initial site regulatory documents
- Preparation of Investigational Product orders for clinical studies
- Maintenance of Clinical Database as needed
- Perform light data entry as needed
- Interact with clinical vendor site Can be assigned to other equivalent support activities to meet business needs
Clinical Research Coordinator
Clinical research coordinator job in Chicago, IL
👋 Meet knownwell, weight-inclusive healthcare for all. Join a dynamic company that is changing the way care is delivered for patients with obesity. knownwell is a weight-inclusive healthcare company offering metabolic health services, primary care, nutrition counseling and health coaching services for anyone of any size. Our hybrid model allows for both in-clinic and virtual care to bring support to patients where and when they need it. To learn more about our recent Series A funding, led by Andreessen Horowitz, please check out this article.
🔍The Clinical Research Coordinator (CRC) is responsible for overseeing and coordinating all aspects of clinical trials, ensuring that studies are conducted in compliance with regulatory requirements, sponsor expectations, and Good Clinical Practice (GCP) guidelines. The CRC will act as the primary liaison between the clinical research team, patients, and external stakeholders, ensuring the efficient and timely execution of clinical research projects.
Location: 25 E Schaumburg Rd #101, Schaumburg, IL 60194 On-site Requirements: Hybrid, mostly on-site. Reports To: Head of Research 🎯 What you'll do:
Study Coordination:
Coordinate and manage all aspects of clinical trials, including patient recruitment, screening, and enrollment.
Schedule and oversee patient visits, ensuring timely collection of data and samples in accordance with the study protocol.
Oversee site initiation, monitoring, closeout activities, and equipment calibration to ensure compliance with study protocols and regulations.
Maintain study documentation, including case report forms, consent forms, and other essential study records.
Review monitoring follow-up letters to ensure timely completion and resolution of identified issues.
Ensure accurate and timely reporting of adverse events (AEs) and serious adverse events (SAEs).
Manage the receipt, shipment, and storage of study drug and trial samples.
Ensure proper handling and storage of study materials, medications, and biological samples.
Generate invoices for study sponsors as applicable or assigned.
Patient Interaction:
Serve as the main point of contact for participants, answering questions and providing information regarding study protocols, treatment options, and expected outcomes.
Ensure patients understand the study's risks, benefits, and requirements by assisting in the informed consent process.
Monitor and document patient progress throughout the study, ensuring that their safety and well-being are maintained.
Data Management:
Enter, maintain, and monitor study data in the clinical trial management system (CTMS) and other relevant databases.
Perform quality control checks to ensure the accuracy and completeness of data.
Collaborate with trial site staff, sponsor or CRO to resolve any discrepancies or issues with study data.
Regulatory Compliance:
Stay current with federal and global regulations, including ICH-GCP and FDA guidelines, and ensure the study's adherence to applicable regulatory requirements, as well as sponsor-specific requirements.
Assist with the preparation and submission of study protocols, amendments, and regulatory documents to the Institutional Review Board (IRB).
Prepare site materials, including training materials, regulatory binders, manuals, and support documentation, ensuring alignment with regulatory guidelines and ethical standards.
Conduct training for study staff on regulatory requirements and ensure compliance with study protocols.
Maintain regulatory binders and drug accountability documents for each study.
Archive all documentation at the end of the study per Sponsor and FDA-required timelines.
Study Team Collaboration:
Work closely with the Principal Investigator, Clinical Research Manager, and other research staff to ensure the study's success.
Communicate with sponsor representatives, providing regular updates on study progress and patient enrollment.
Assist with study recruitment strategies and participate in outreach activities.
🌟 Who you are:
Education:
Bachelor's degree in a related field (e.g., life sciences, nursing, healthcare);CCRC Certification, and/ormaster's degree preferred.
GCP, BLS, IATA, and CSSR Certifications (or willingness to acquire if hired).
Experience:
3+ years of experience in clinical research and industry environments. 2+ years of experience with independent trial management preferred.
Solid understanding of drug development processes, FDA, and ICH GCP guidelines.
Proficiency in using multiple software systems and computer technology (preference for experience with Florence, Advarra and Greenphire).
Skills:
Strong organizational, leadership, and time-management skills.
Excellent written and verbal communication skills.
Ability to work independently and as part of a multidisciplinary team.
Experience working on collaborative, diverse, and feedback-driven teams.
Proven history of adapting and thriving through periods of change.
$50,000 - $75,000 a year
The annual salary range for this position is part of a comprehensive benefits package that includes health insurance, a 401(k) plan, and bonus opportunities. In compliance with applicable state laws, knownwell provides this reasonable compensation estimate. Final pay will be determined based on various factors, including qualifications, experience, skills, and internal equity.
Pay & Perks:💻 Fully remote opportunity🩺 Medical, dental, and vision insurance📈 401K retirement plan with company match🏝️ Up to 20 days of PTO per year + company holidays👶 Up to 14 weeks of paid parental leave (12 for non-birthing parents) 🏡 Annual work from home stipend for remote employees
If you are an ambitious and experienced healthcare professional who is passionate about transforming healthcare and creating meaningful change, we invite you to apply and join our dynamic team. Please send us a note at hiring@knownwell.health.
knownwell, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Based on current size of the clinic and HIPAA regulation, providers cannot receive care in clinic and provider's household members cannot receive primary care in the clinic.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Auto-ApplyClinical Research Coordinator
Clinical research coordinator job in Chicago, IL
WE ARE INSIGHT: Envisioning and implementing a holistic approach to neurological treatment is our goal, and our unique research and powerful solutions illuminate the path toward greater innovations for the future of healthcare. Patients and families seeking effective surgical procedures, rehabilitation, and neurological treatment can trust in our highly skilled and renowned surgical team. As we provide comprehensive services at our state-of-the-art inpatient and outpatient facilities, we remain driven by our basic oath to help patients heal while providing a genuine, human touch.
The Clinical Research Coordinator (CRC) will work collaboratively with a multi-institutional team. The CRC will support principal investigators, work as a link between sponsor and institute, oversee details of clinical studies and ensure compliance with study review board and clinical research regulations. The CRC can be part of multiple research projects and should have the ability to multi-tasks.
Duties
* Provide technical support and assist Principal Investigators in study design and operations.
* Direct, and coordinate clinical trials projects.
* Solicits industry trials for potential participation.
* Act as a main point of contact for study protocols and coordinate between clinical study team and CRO/Sponsor.
* Evaluate protocols and assist in study selection.
* Implement and ensure clinical trials operations and regulatory compliance.
* Review GCP guidelines, maintain GCP/CITI certification and obtain study-specific required certification for participating study staff.
* Manage all clinical trial patients enrolled in studies, discuss protocols and informed consents, and ensure eligibility criteria and recruitment.
* Coordinate all study visits including site initiation, study closeout, external audits, and monitoring visits.
* Create study-specific source document binders for each study and subject.
* Maintain regulatory documents required for study site, sponsor, and IRB for initiation, interim reports, and close-out documentation.
* Assign tasks to other members of the research team, ensure they comply with the protocols, and ensure performing all protocol visits, assessments, and procedures.
* Maintain databases for all clinical trials.
* Report adverse events to the Data Safety and Monitoring Board, sponsor, IRB, FDA and all governing bodies.
* Submit protocols and amendments to the IRB.
* Complete study source documentation, complete study report forms via proposed procedure, maintain proper study close-out and ensure meeting sponsor deadlines.
Requirements
Education:
* Bachelor's degree in health-related field with minimum one year experience as a CRC is required
* - Two years healthcare related field experience or experience in human research.
* - Clinical research certification
* GCP and IATA certification are required (or willing to obtain them within the first month of assignment).
* SOCRA or ACRP certification are preferred.
* Basic Skills:
* Medical terminology and knowledge of disease processes
* Working knowledge of clinical research design and regulatory requirements
* Analytical skills to gather and interpret research data.
* Excellent interpersonal, verbal, and written communication skills.
* Organized and detail-oriented individual.
* Comfortable working in a team environment
* Capability to work under minimal supervision
* Proficient in spreadsheets and clinical research software.
* Understand clinical procedures, regulations and be an excellent team player working with physicians, nurses, non-clinical, laboratory and ancillary staff
* Capability to meet data deadlines and maintain confidentiality
* Ability to travel to INSIGHT local offices when needed
* Behavioral Competencies:
* Ability to relate and work effectively with others.
* Demonstrated skills in verbal and written English communications for safe and effective patient care and to meet documentation standards.
* Proven excellence in patient safety and care.
* Friendly, empathetic & respectful.
* Reliable in work results, timeliness & attendance.
* Ability to relate to and work effectively with a wonderfully diverse populace.
* Able to work in a fast-paced, and stressful environment while maintaining positive energy.
* Able to work under pressure and in situations that benefit from patience, tact, stamina and endurance.
* Detailed oriented, conscientious and committed to precision in work results.
* Committed to contributing to a positive environment, even in rapidly changing circumstances.
* Is aware of standards and performs in accordance with them.
* Able to provide eligibility for employment for any U.S. employer.
Benefits:
* Paid Sick Time - effective 90 days after employment
* Paid Vacation Time - effective 90 days after employment
* Health, vision & dental benefits - eligible at 30 days, following the 1st of the following month
* Short and long-term disability and basic life insurance - after 30 days of employment
Insight Employees are required to be vaccinated for COVID-19 as a condition of employment, subject to accommodation for medical or sincerely held religious beliefs.
Insight is an Equal Opportunity Employer & Values Workplace Diversity!
Clinical Research Coordinator I
Clinical research coordinator job in Chicago, IL
Clinical Research Coordinator I The Clinical Research Coordinator I, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.
Duties & Responsibilities:
Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
a. Sponsor-provided and IRB-approved Protocol Training
b. All relevant Protocol Amendments Training
c. Any study-specific Manuals Training, as applicable
d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.
Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.
Submitting required administrative paperwork per company timelines.
Participating in subject recruitment and retention efforts.
Engaging with Research Participants and understanding their concerns.
Any other matters, as assigned by management.
Knowledge & Experience:
Education:
High School Diploma or equivalent required
Bachelor's degree a plus
Foreign Medical Graduates preferred
Experience:
At least one years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.
At least two years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting
Credentials:
ACRP or equivalent certification is preferred
Registered Medical Assistant certification or equivalent is preferred
Knowledge and Skills:
Be an energetic, go-getter who is detail-oriented and can multi-task.
Be goals-driven while continuously maintaining quality.
Bilingual in Spanish is preferred
Clinical Research Coordinator III
Clinical research coordinator job in Chicago, IL
Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report.
Day (United States of America)
Location
American Dental Associates (ADA)
Job Description
Coordinates all clinical research activities with minimal supervision. Adheres to the service values and principles as well as the principles of research ethics. Based on specific research program needs, patient facing vs. data administrative responsibilities will vary.
Essential Job Functions:
Coordinates and oversees all aspects of clinical research projects, including study start-up, site qualifications, initiation, monitoring, and close-out visits.
Oversees site visits, promptly addresses sponsor queries, and ensures strict adherence to study protocols and regulatory requirements throughout all study activities.
Manages regulatory compliance and documentation processes, including preparing and maintaining regulatory documents, registering studies on clinicaltrials.gov if required, assisting investigators with regulatory submissions such as to the FDA, and developing and updating Standard Operating Procedures (SOPs) to ensure adherence to research protocols and regulatory standards.
Promotes ethical conduct in research and ensures integrity in all aspects of study conduct and data handling.
Manages logistical and administrative aspects of clinical research projects by maintaining inventory of supplies and equipment, preparing lab kits and requisitions, organizing, and maintaining study documents including regulatory binders and source documents, tracking deadlines for grants and deliverables, and constructing codebooks for data dictionaries.
Manages participant engagement throughout clinical research studies by identifying and recruiting eligible subjects, conducting informed consent/assent processes, coordinating subject reimbursement, verifying participant eligibility, and serving as the primary point of contact for study-related inquiries and support.
Manages the data lifecycle in clinical research by abstracting information from medical records, entering data into case report and study forms, preparing abstracted/coded data for analysis, conducting statistical analyses, and ensuring database validity and integrity through QA/QC checks and data monitoring processes.
Manages some financial aspects of research projects by assisting in budget preparation and fund review, as well as supports the research central offices and Principal Investigator (PI) in grant preparation and reporting activities.
Provides comprehensive training and mentorship to research personnel by assisting in study conduct training, serving as a mentor and resource, and assists the onboarding process for new study team members.
Leads the dissemination of research findings through manuscript preparation, collaboration on abstracts/posters, presentation of research at national meetings, or coordination of research education conferences.
Other job functions as assigned.
Knowledge, Skills, and Abilities:
Bachelor's degree and two or more years research experience required.
Two-three years with complex research projects preferred.
Strong organizational skills with ability to manage multiple simultaneous studies.
Strong verbal and written communications skills.
Strong knowledge of FDA, HSR, and GCP Guidelines.
Strong analytical skills with the ability to recognize quantitative and qualitative research methods and remain agile and adaptable to various technological systems.
May assist in technology system implementation.
Strong leadership skills with the ability to prioritize tasks, problem solve, and serve as a mentor. Ability to foster an inclusive environment where all team members feel valued and respected.
Education
Bachelor's Degree (Required)
Pay Range
$59,280.00-$96,928.00 Salary
At Lurie Children's, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits.
Benefit Statement
For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes:
Medical, dental and vision insurance
Employer paid group term life and disability
Employer contribution toward Health Savings Account
Flexible Spending Accounts
Paid Time Off (PTO), Paid Holidays and Paid Parental Leave
403(b) with a 5% employer match
Various voluntary benefits:
Supplemental Life, AD&D and Disability
Critical Illness, Accident and Hospital Indemnity coverage
Tuition assistance
Student loan servicing and support
Adoption benefits
Backup Childcare and Eldercare
Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members
Discount on services at Lurie Children's facilities
Discount purchasing program
There's a Place for You with Us
At Lurie Children's, we embrace and celebrate building a team with a variety of backgrounds, skills, and viewpoints - recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care.
Lurie Children's and its affiliates are equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law.
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