Clinical Research Associate I - Telemetry Monitor Technician
Clinical research associate job in Grayslake, IL
Clinical Research Associate (CRA) I - Telemetry Monitor Technician
Onsite in Grayslake, IL 60030
1 year initial contract
Hourly Pay Rate: $27-30/hr (medical benefits available at a cost)
Name of Functional Area/Department: Clinical Pharmacology & Pharmacometrics Research Unit
Hours: The new position would be primarily pm weekdays, available weekends and an occasional overnight shift for coverage after completing training. Training would need to occur on 1st shift (The training schedule is 4-8 weeks, M-F 7a-3:30p, depending on progress)
Internal Position Title: Telemetry Monitor Technician
This role requires face-to-face interactions with our subjects. It also requires hands on skills that require physical contact with some activities (ex: phlebotomy, ECG collections, vitals signs).
Minimum Education Required:
High School Diploma or equivalent
Minimum Experience Required:
1-2 years of work experience in a clinical or research environment; and documented proficiency in Cardiac Arrhythmia (must have experience) recognition.
Major Job Responsibilities:
Review protocols and comply with study-specific activities that impact telemetry areas of responsibility.
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., telemetry monitoring, etc., as assigned.
Assist with telemetry monitoring system set-up and preparation of telemetry transmitters and related documentation.
Participate in continuous cardiac telemetry monitoring of study subjects, as required by the study protocols, and seek assistance as needed.
Assist with telemetry data review in the telemetry monitoring system and generation of Holter reports, as appropriate.
Maintain safety and confidentiality of study subjects throughout the study.
Understands and complies with SOPs, FDA regulations, and basic GCP requirements.
What are the top 5 skills/requirements this person is required have?
a. Required Skill 1: Cardiac Arrhythmia and phlebotomy
b. Required Skill 2: Lab work
c. Required Skill 3: drawing blood
d. Required Skill 4: taking Vital signs
e. Required Skill 5: clinical and/or hospital setting. Paramedic and firefighters do well in this position.
Our role in supporting
diversity
and
inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Clinical Associates - Neonatology
Clinical research associate 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 associate job in Chicago, IL
Department: MED-Physical Med & Rehab Salary/Grade: RES/ Target hiring range for this position will be between $75,000-$100,000 per year. 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.
Job Summary:
The Clinical Research Associate is responsible for coordinating clinical research-related activities as well as providing clinical research support to the research group. The PA/NP manages activities associated with highly complex clinical research studies including investigator-initiated trials single and multi-center trials and industry-initiated trials. Responsibilities include: performing patients assessments, conducting patient visits, collecting and documenting clinical research data, attending clinical trial conferences and meetings, acting as a liaison between patients and physicians, and acting as a resource to research study patients, physicians, and other/clinical personnel. This individual is the primary contact for all participants and coordinators to access at any time of day. This individual uses advanced communication skills to problem solve complex situations. This individual will provide clinical support and clinical research activities to the PI. This individual acts as a sub investigator on all clinical trials at any given time. The hours for this job are flexible and can be either part-time or full-time.
Specific Responsibilities:
Nurse Practitioner/Physician Assistant
* Become familiar with all protocols conducted at the center. Participates in the initiation of study start-up activities. Contributes to the implementation of protocols and monitors study activities at all stages.
* Evaluates volunteer subjects for potential study qualification in accordance with inclusion/exclusion criteria provided by study sponsor. Assists in patient recruitment as well as acting as a resource for the marketing personnel and
* referring physicians.
* For qualified participants, initiates medical and social histories, physical exam, and physiological measures as indicated in protocol. Records this data in detail. Schedules study visits as required by protocols.
* Ensures appropriate laboratory, x-ray and other diagnostic examinations are
* scheduled and completed per study protocol. Oversees any outside services as required. Conducts all necessary laboratory and imagining tests.
* Performs complete medical histories and physical examinations for qualified participants with emphasis on patient's presenting complaints and findings pertinent to the study. Discriminates between normal and abnormal findings onhistory and physical in order to establish a differential diagnosis. Provides clinical support for divisional research activities within scope of license.
* Review medical, laboratory, and other diagnosis data on study patients. Recognizes conditions beyond the scope of the Nurse Practitioner/Physician Assistant and confers with principal investigator. Makes principal investigator aware of any significant abnormalities. Notifies and follows up with patients as
* appropriate.
* Assists coordinators in assessment of adverse events. Ensures that serious adverse events are reported to the principal investigator and sponsor in a timely manner. Follows up with patients or patient family members in accordance with
* procedures. Knowledge of community resources needed for patients.
* Assists with collection of data requested by protocol. Ensures accuracy of data obtained. Collates and enters data into patient charts, sponsor case report forms,
* and/or remote data entry equipment in a timely and precise manner.
* Ensures that all study drug received in unit is accurately documented and sorted in locked location. Ensures that study drug is maintained in appropriate temperature controlled environment. Verifies that all study drugs is correctly labeled, and packaged. Ensures that appropriate study drug is dispensed to patient
* along with detailed instructions on use. Maintains accurate documentation of each of these along with return study drug.
* When studies require other supplies and/or equipment, will ensure their availability and ensure proper orientation has occurred prior to use.
* Ensures patient compliance with study drug and study visits. Documents all efforts made to retrieve study medication. Notifies sponsor of any deviations from protocol. Whenever possible, obtains permission prior to deviation.
* Schedules routine study reviews with sponsor monitors or appointed sponsor representative. Arranges access to all subject records for the indicated time period
* of review. Allows time to respond to monitor questions and to make corrections to case report forms. Promptly respond to sponsor queries.
* Prepares for and completes close out procedures for terminated studies. Ensures
* all FDA, sponsor, and center regulations have been followed.
* Assist with training of other center personnel who will be directly involved with the assigned study.
* Works with other research coordinators and research assistants to provide back-up, replacement during absences, and follow-up as needed.
* Provides health practices information and education to study patients regarding
* medications, disease, diet, exercise, and any special procedures. Assists patients by providing appropriate referrals to physicians, clinics, or agencies.
* Provides on-call services for study patients during evening and weekend on rotation basis with other coordinators/nurse practitioners/physician assistants.
* Performs diagnostic procedures as required by study protocol.
* Assists in training of center personnel, especially in the clinical assessment skills including blood draw and performing ECGs . Ensures gowns, gloves, goggles, masks and other personal protective equipment are used properly by all staff.
* Participates in other division activity such as special projects, in-service, training, and any other duties assigned by supervisor
* Must take the certification exam within 2 years, or with 1 year if has 1 year previous experience as a research coordinator.
Miscellaneous
Performs other duties as assigned.
Minimum Qualifications: (Education, experience, and any other certifications or clearances)
* Graduate of an accredited Nurse Practitioner or Physician Assistant program; current Illinois licensure.
* 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)
* Excellent clinical assessments skills
* Detail-oriented and highly organized.
* Ability to understand technical research protocols.
* Excellent problem solving skills.
* Able to make decisions independently and yet must be team oriented.
* Must possess ability to articulate and clearly communicate study information to patients, and otherhealth care professionals.
* Excellent written and oral communication skills.
* Professional demeanor with ability to interact with pharmaceutical/sponsor representatives,regulatory agents, medical center administration, medical staff, peers, and patients.
Preferred Qualifications: (Education and experience)
* Previous research experience and 3+ years clinical experience as a Nurse Practitioner/PhysicianAssistant.
* Graduate of an accredited master's program for Nurse Practitioner or Physician Assistant.
Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more.
Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more.
Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more.
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.
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Clinical Research Associate (West Coast)
Clinical research associate 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.
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#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 associate 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
Clinical Research Associate
Clinical research associate 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
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#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-ApplySenior Clinical Research Associate (CRA)
Clinical research associate 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 Associate (CRA) - A
Clinical research associate 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.
Senior Clinical Research Associate (FSP) - Central Region - Oncology
Clinical research associate job in Chicago, IL
Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix. Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as pplicable
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs
additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to other project work and initiatives for process improvement, as required.
Compensation and Benefits
The salary range estimated for this position based in Illinois is $82,800.00-$135,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: *****************************************************
Auto-ApplyClinical Research Scientist Interventional Solutions
Clinical research associate 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
Senior Clinical Research Associate (level dependent on experience)
Clinical research associate job in Chicago, IL
Senior Clinical Research Associate (home based) (level dependent on experience) Job Purpose/Summary To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance.
Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts.
What You'll Do
Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor
Creates and implements subject enrollment strategies for assigned investigative sites.
Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan.
Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material.
Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product.
Participates in development of CRFs and other study related documents
What You Bring
Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or
RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience
Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it:
We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward
We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department
We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.
Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs
Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
Senior Clinical Research Associate (Midwest - Illinois/Michigan)
Clinical research associate job in Chicago, IL
Sr. Clinical Research Associate NY/NJ
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 (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.
What You Will Be Doing:
Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
Your Profile:
Advanced degree in a relevant field such as life sciences, nursing, or medicine.
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
Must be located in the Midwest (areas like Chicago or Detroit/Ann Arbor, MI are ideal)
Oncology monitoring experience required
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
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-ApplySenior Clinical Research Associate
Clinical research associate job in Chicago, IL
Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties
* All aspects of site and registry management as prescribed in the project plans
* Organize and make presentations at Investigator Meetings
* Report, write narratives and follow-up on serious adverse events
* Review progress of projects and initiate appropriate actions to achieve target objectives
* You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required
* Participate in the development of protocols and Case Report Forms as assigned
* Interact with internal work groups to evaluate needs, resources and timelines
Qualifications
* 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment
* Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines
* Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas
* Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process
* Good planning, organization and problem solving abilities
* Good communication and interpersonal skills
Additional Information
All your information will be kept confidential according to EEO guidelines.
UX Research Coordinator
Clinical research associate job in Milwaukee, WI
About the Job: The Research Coordinator's role is to help the research practice operate more efficiently. They do this by handling the logistics to make research run smoothly so that researchers can focus on what they do best - conduct research. Research Coordinator duties may include project and client management, creating and managing materials for research, participant recruitment and session scheduling, incentive management, tool and data management, etc.
What You'll Do:
Coordinate research participant recruitment
o Identify and recruit research participants per researcher specifications
o Coordinate schedules of research participants, researchers, and stakeholders
o Manage incentives
o Manage lists of past and future research participants
Manage software systems used for data collection and analysis
Coordinate with Design Program Managers, Design Leads, and other stakeholders
Work as part of the larger Design Operations team and may be called upon to do operational work for the broader design organization.
If capacity allows, manage projects across the research organization. Including
o Prepare study materials and data collection tools for research sessions
o Schedule planning, research, and report-out sessions for researchers
o Prepare data for analysis
o Create and manage data repositories and handle records retention
Skills You Have:
Bachelor's degree, or equivalent
Experience providing operational support to fast-paced research teams.
Experience with research participant recruitment
Demonstrated skills in increasing team efficiency.
Strong communication and organizational skills with attention to the right details to ensure operations run smoothly
An ability to anticipate and proactively solve logistical issues so your team knows they'll never miss a beat when you're coordinating their work
Additional Qualifications We'd Love:
2 years' experience collaborating with live research teams.
Experience working in a highly regulated environment like healthcare or financial services.
Professional association with the Research Ops community.
#LI-Hybrid
Compensation Range:
Pay Range - Start:
$60,340.00
Pay Range - End:
$112,060.00
Geographic Specific Pay Structure:
Structure 110:
$66,360.00 USD - $123,240.00 USD
Structure 115:
$69,370.00 USD - $128,830.00 USD
We believe in fairness and transparency. It's why we share the salary range for most of our roles. However, final salaries are based on a number of factors, including the skills and experience of the candidate; the current market; location of the candidate; and other factors uncovered in the hiring process. The standard pay structure is listed but if you're living in California, New York City or other eligible location, geographic specific pay structures, compensation and benefits could be applicable, click here to learn more.
Grow your career with a best-in-class company that puts our clients' interests at the center of all we do. Get started now!
Northwestern Mutual is an equal opportunity employer who welcomes and encourages diversity in the workforce. We are committed to creating and maintaining an environment in which each employee can contribute creative ideas, seek challenges, assume leadership and continue to focus on meeting and exceeding business and personal objectives.
Auto-ApplyClinical Trial Manager - VCTS / Part-Time
Clinical research associate job in Wauwatosa, WI
Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.
Position Summary
Under the direction of the Principal Investigators (PIs) and applicable sponsors, is responsible for planning and operationally leading the multi-site coordination of research trials from initiation to completion in compliance with applicable regulations and requirements. Manages trial budgets and implements and oversees systems to manage the conduct of the clinical trials and the flow of information among stakeholders and sites.
Total Rewards Package
Benefits
Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.
Responsibilities
Responsible for regulatory management including the development of IRB submissions, pharmacy control plans, training materials, questionnaires, case report forms, data analytics infrastructure, amendments, continuing review, study closeout, monitoring, and reporting of adverse events. Oversees review and approval at partner site(s).
Coordination of all study activities with external and internal resources to complete research aims including managing vendor relationships as needed for the conduct of applicable trials (central lab, home health, etc.)
Oversee compliance and conduct of the research protocol. Monitors safety and is involved in reviewing and analyzing adverse events and unanticipated events at participating sites. Provides oversight to ensure confidentiality of data, protocol compliance, evaluation of problems and complaints.
Prepare and manage budgets and provide necessary financial information for grants, subcontracts, and sponsors. May complete study specific invoicing.
Serves as a liaison between Principal Investigator (PI) and stakeholders (sponsors, IRB, sites, etc.) by assisting the PI in day-to-day operations of the projects.
Determine data management plans and ensure that all data is collected, entered, analyzed and reported accurately. Performs quality checks and designs systems to monitor and extract data. May include site visits and auditing of data.
Provide training and create documentation to support the research study (training manuals, educational, promotional materials).
Design and maintain databases and systems to manage information, data and studies. Evaluate and improve processes for data entry, data extraction and record keeping.
Generate, extract, analyze and, compose original scientific material for use in abstracts, publications, progress reports and grants. Participate and present at national and international research meetings and conferences.
Supports in planning and conducting Investigator Meetings
Reviews and approves release of investigational product or device shipments
Maintains confidentiality of all subject-related records including written and verbal communications.
Coordinates on-site and off-site meetings for project planning purposes and educational events as assigned.
Serve as Project Manager (PM) for studies that do not have one also assigned and may provide coverage for others and/or may supervise, instruct and direct the work of others including Clinical Research Associates (monitors).
As a skilled specialist, completes tasks in resourceful and effective ways. Tasks involve forward planning and anticipation of needs/issues.
Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification
Understands and performs in accordance with all applicable regulatory and compliance requirements
Complies with all standard operating policies and procedures
Qualifications
Education
Bachelor's Degree in a health sciences, biological sciences, nursing, pharmacy, or related field required
Master's Degree in science or another related field preferred
Experience
7-9 years Clinical Research Experience in regulatory and industry operations required
10+ years Healthcare/research experience required
Less than 1 year Experience with related clinical research preferred
Knowledge, Skills and Abilities
Ability to be an effective liaison between study subjects and sponsors, investigators, health care workers, and collaborating professionals required
Advanced verbal and written communication skills including the ability to write, interpret and explain research studies and procedures required
Advanced ability to design, implement and manage projects that include planning, organization, prioritization, problem solving and performance of project tasks to ensure project completion within designated timeframes required
Very strong attention to detail and ability to evaluate and ensure accuracy of data related to laboratory results, subject health history, and data collection and reporting required
Ability to evaluate and extract data from medical records with ability to spot errors and trends and address promptly required
Strong knowledge of regulations associated with human subject research required
Ability to work in an independent manner while providing mentorship to others required
Tasks involve a considerable degree of forward planning and anticipation of needs or issues required
Licenses and Certifications
ACRP CCRC or CCRA or SOCRA CCRP Certification upon hire required
Tools and Technology
Personal computer (laptop) required
General office equipment (computer, printer, copy machine) required
Microsoft Suite (Word, Excel, PowerPoint) required
Electronic Data Capture systems such as Redcap, Medidata, Inform, etc. required
Electronic Trial Master File systems such as Florence eBinders required
Electronic consent platforms such as Redcap or Florence eConsent required
EPIC medical record system preferred
Not ready to apply? Connect with us for general consideration.
Auto-ApplySenior/Lead Clinical Research Coordinator
Clinical research associate 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 Coordinator II
Clinical research associate 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.
Travel Clinical Research Coordinator
Clinical research associate 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: ********************************
Clinical Research Coordinator Lead
Clinical research associate 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 associate job in North 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.
Location
Superior Street
Job Description
The Clinical Research Coordinator II coordinates all clinical research activities with moderate supervision. Adheres to the service values and principles of research ethics. The balance between patient-facing and administrative data tasks varies according to the specific requirements of each research program. In this role, you collect biospecimens such as nasal swabs, buccal swabs, and stool samples from research participants. You are then responsible for ensuring the proper processing, storage, and shipping of those samples.
Essential Job Functions:
Coordinates and manages the initiation and regulatory compliance of clinical research studies, including preparing all necessary documents for IRB and sponsor review, coordinating study conduct across departments, and securing required approvals.
Manages study documents, including regulatory binders, source documents, and correspondence, while maintaining adherence and compliance to research protocols.
Coordinates and oversees all aspects of clinical research visits, including arranging and conducting visits, conducting site qualifications, initiation, monitoring, and close-out visits.
Collects specimens from subjects and ensures proper processing, records data on source documents and electronic systems, and conducts literature searches while assisting with QA/QC procedures to ensure data accuracy and protocol compliance.
Manages participant engagement throughout clinical trials by identifying eligible subjects, conducting informed consent processes, coordinating reimbursement, verifying eligibility, and serving as the primary patient liaison for study-related inquiries and support.
Manages and oversees all aspects related to supplies and equipment inventory, including preparation of lab kits and requisitions.
Tracks and manages deadlines for grants and deliverables.
Prepares abstracted and coded data for subsequent processing and analysis, while also developing codebooks for data dictionaries to ensure comprehensive data organization and accessibility.
Participates actively in investigator meetings, contributing to the ethical conduct of research through educational initiatives, and represents research findings at meetings and conferences.
Assists with financial aspects of studies including invoicing and billing management.
Other job functions as assigned.
Knowledge, Skills, and Abilities:
Bachelor's degree and one year research experience required.
A combination of education and/or experience may be considered in lieu of the degree when the experience is directly related to the duties of the job.
Proficient organizational skills with ability to manage multiple studies.
Proficient verbal and written communications skills.
Proficient knowledge of FDA, HSR, and GCP Guidelines.
Proficient analytical skills with the ability to recognize quantitative and qualitative research methods and remain agile and adaptable to various technological systems.
Proficient entry level leadership skills.
Recognizes the need to prioritize tasks, problem solve, and work with others. Assists to foster an inclusive environment where all team members feel valued and respected.
Education
Bachelor's Degree (Required)
Pay Range
$49,920.00-$81,619.20 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.
Support email: ***********************************
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