155 Clinical Research jobs in Chicago
Epic Clinical Project Manager
60290 Chicago, Illinois
Impact Advisors
Posted 13 days ago
Job Viewed
Job Description
Join to apply for the Epic Clinical Project Manager role at Impact Advisors Join to apply for the Epic Clinical Project Manager role at Impact Advisors Epic Clinical Project Manager – FLEXIBLE LOCATION (Travel required) About Us Impact Advisors, LLC is a nationally recognized healthcare management consulting firm delivering Best in KLAS advisory, implementation, and optimization services. We are driven by a commitment to exceed client expectations and are proud to be a trusted partner to many of the nation's leading healthcare organizations. Our mission to drive patient-centered, value-driven outcomes has earned us prestigious industry accolades. To learn more about us, visit Job Overview Impact Advisors is seeking a dynamic and motivated Epic Clinical Project Manager to join our team. In this role, you will be instrumental in managing medium to large-scale projects with medium to high levels of complexity, including planning, budgeting, resource management, deliverables, development, timelines, issues and risks. This position offers a unique opportunity to contribute to client success while making a meaningful impact on the healthcare industry. Responsibilities Manage medium to large-scale projects to achieve project goals while controlling resources, risks, conflicts, timeliness, and costs. Lead and execute Epic clinical implementations initiatives, ensuring efficient and effective use of Epic modules to enhance performance. Develop project scope, deliverables, and plan in alignment with project objectives. Collaborate with client stakeholders to understand business requirements, identify gaps, and implement solutions that align with industry best practices. Provide expertise on Epic functionality, configurations, and workflow. Travel, as necessary, to client sites to perform required tasks. Qualifications 5+ years of experience managing multiple Epic implementations and cross-functional teams and utilizing certifications in at least one Epic modules (Orders, Ambulatory, Willow, or Beacon is preferred). Education And Experience Bachelor's degree Minimum 5+ years of professional experience managing Epic implementations is required. Epic Certification (Orders, Ambulatory, Willow, or Beacon is preferred). Skills And Competencies Proven experience managing Epic implementations. Ability to interact with all levels of healthcare professionals and staff in one-on-one and group settings. Plan, budget, communicate issues and risks. Additional Information Ability to travel up to 75%, as needed. Work schedule is typically M-F. At Impact Advisors, we prioritize transparency and equity in our compensation practices. This role has a salary range of $145,000 - $90,000 and may also be eligible for an annual discretionary bonus. This range accounts for various factors, including skills, experience, training, certifications, and organizational needs. Our People and Culture At Impact Advisors, we cultivate a caring, fun, honest, and autonomous work environment. Our success stems from our associates' dedication and a shared mission to create a “Positive Impact.” We embrace diversity and inclusion, fostering an environment where all employees feel valued and empowered. Join Impact Advisors and make a real difference in healthcare. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Project Management and Information Technology Industries Hospitals and Health Care Referrals increase your chances of interviewing at Impact Advisors by 2x Sign in to set job alerts for “Clinical Project Manager” roles. Chicago, IL $93,000 170,000 4 months ago Chicago, IL 115,000 - 130,000 3 months ago Clinical Research Manager, Research Incubation Unit Chicago, IL 90,000 - 130,000 5 months ago Clinical Research Manager, CTMS Support Unit Chicago, IL 110,000.00 - 160,000.00 4 weeks ago Chicago, IL 110,000.00 - 160,000.00 1 day ago Clinical Trial Manager (CMO) - Post-Trial Access CLINICAL PROGRAM MANAGER (Adolescent males and pediatrics) - Full time. Clinical Research Manager-Kellogg Cancer Center Research Manager-Diabetes and Cardiometabolic Clinical Research Program Client Services Manager - Clinical Research Manager, Clinical Product Marketing, BDI Chicago, IL 90,000.00 - 105,000.00 3 weeks ago Manager, Clinical Care Case Management - Remote Chicago, IL 100,000 - 200,000 2 weeks ago Chicago, IL 90,000 - 105,000 5 months ago Director, Strategic Partnerships & Client Relationship Business Development Manager / Director, (Discovery, Pre-Clinical & CMC)- Midwest Chicago, IL 150,000 - 200,000 5 months ago Assistant Clinical Manager - Operating Room Streeterville, IL 76,960 - 125,840 1 month ago Chicago, IL 72,000 - 114,000 3 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
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0
Clinical Research Associate
60611 Chicago, Illinois
$70000 Annually
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical research organization, is actively seeking a diligent and experienced Clinical Research Associate (CRA) to join their team in Chicago, Illinois, US . This role is pivotal in ensuring the successful execution of clinical trials, adherence to protocols, and compliance with regulatory guidelines. The CRA will be responsible for monitoring clinical sites, ensuring data integrity, and supporting investigators to achieve study objectives. This is an excellent opportunity for a professional with a passion for advancing medical science and contributing to the development of life-changing therapies.
Key Responsibilities:
Key Responsibilities:
- Conduct on-site, remote, and/or in-house monitoring visits for clinical trials across various phases and therapeutic areas.
- Ensure clinical sites adhere to study protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and applicable regulatory requirements.
- Verify source data against Case Report Forms (CRFs) for accuracy, completeness, and consistency (Source Data Verification - SDV).
- Review informed consent forms (ICFs) for proper execution and documentation.
- Manage investigational product accountability, storage, and reconciliation at clinical sites.
- Train site staff on study protocols, procedures, and regulatory requirements.
- Identify and resolve site-related issues, escalating complex problems to the study team as needed.
- Prepare comprehensive monitoring visit reports and follow-up letters in a timely manner.
- Maintain effective communication with clinical investigators, site staff, and internal study teams.
- Review regulatory documents at sites to ensure compliance and completeness.
- Assist in the preparation and review of study-related documents such as protocols, CRFs, and study manuals.
- Participate in investigator meetings and other study-related training sessions.
- Contribute to the identification and selection of qualified clinical sites.
- Ensure timely data entry and query resolution at assigned sites.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related health-scientific discipline.
- Minimum of 2-4 years of experience as a Clinical Research Associate, preferably within a CRO or pharmaceutical company.
- Strong knowledge of ICH-GCP guidelines and applicable regulatory requirements (e.g., FDA regulations).
- Excellent understanding of clinical trial processes and methodologies.
- Proven ability to perform source data verification and site monitoring activities.
- Exceptional organizational skills and attention to detail.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office Suite and clinical trial management systems (CTMS).
- Ability to travel frequently (up to 50% or more) as required for site visits.
- Ability to work independently and manage multiple priorities effectively.
- Strong problem-solving and critical thinking abilities.
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1
Clinical Research Associate
60602 Chicago, Illinois
$99002 Annually
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client is currently seeking a highly motivated and skilled Clinical Research Associate to join their growing team. This is a Full-time opportunity to contribute to cutting-edge projects and drive impactful solutions. Our client is a leading innovator in their field, committed to driving progress and delivering exceptional results. They foster a dynamic and collaborative work environment where innovation thrives and employees are empowered to make a significant impact. With a strong focus on professional development and a culture of continuous learning, they offer unparalleled opportunities for career growth. This role is crucial to their ongoing success and will play a key part in achieving strategic objectives. This is an on-site position based primarily at their state-of-the-art facility in Chicago, Illinois, US .
Position Overview:
As a Clinical Research Associate, you will be instrumental in developing new research methodologies. You will collaborate closely with cross-functional teams, leveraging your expertise to expand market reach. This role demands a proactive approach, strong problem-solving skills, and a commitment to excellence. You will be expected to contribute to a culture of innovation and continuous improvement. The ideal candidate will have a proven track record of success in pharmaceutical and be eager to take on new challenges.
Key Responsibilities:
Qualifications:
Preferred Skills (Bonus Points!):
Benefits: Our client offers a competitive salary and a comprehensive benefits package, including health, dental, and vision insurance, a 401(k) retirement plan with company match, generous paid time off, and opportunities for professional development and training. They are dedicated to fostering an inclusive and diverse workplace where every employee feels valued and can thrive. Join a company that is making a real difference and where your contributions are recognized and rewarded. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
If you are a driven and passionate professional looking for an exciting new challenge, we encourage you to apply! This is an exceptional opportunity to advance your career and work with a team of dedicated experts.
Position Overview:
As a Clinical Research Associate, you will be instrumental in developing new research methodologies. You will collaborate closely with cross-functional teams, leveraging your expertise to expand market reach. This role demands a proactive approach, strong problem-solving skills, and a commitment to excellence. You will be expected to contribute to a culture of innovation and continuous improvement. The ideal candidate will have a proven track record of success in pharmaceutical and be eager to take on new challenges.
Key Responsibilities:
- Conducting clinical trials and managing research protocols in accordance with regulatory guidelines.
- Analyzing drug efficacy and safety data, preparing reports for submission to regulatory bodies.
- Ensuring compliance with GCP, GLP, and GMP standards throughout the drug development lifecycle.
- Collaborating with cross-functional teams including R&D, manufacturing, and marketing.
- Monitoring pharmacovigilance activities and adverse event reporting.
- Collaborate with inter-departmental teams to achieve project milestones and objectives.
- Prepare comprehensive reports and presentations for stakeholders, outlining progress and recommendations.
- Stay updated on industry trends, emerging technologies, and best practices relevant to pharmaceutical.
- Participate in continuous improvement initiatives, identifying areas for optimization and implementing effective solutions.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Pharmacology, Life Sciences, Clinical Research, or a related field or a related discipline.
- 3-6 years of progressive experience in pharmaceutical or a closely related field.
- Strong analytical and problem-solving abilities, with attention to detail.
- Excellent communication, interpersonal, and presentation skills.
- Ability to work independently and as part of a collaborative team in a fast-paced environment.
- Proficiency in relevant software and tools Electronic Data Capture (EDC) systems, SAS, R, clinical trial management systems (CTMS).
Preferred Skills (Bonus Points!):
- Proven leadership experience or ability to mentor junior team members.
- Experience with regulatory affairs experience (FDA, EMA), medical writing, or specialized therapeutic area expertise.
- Certifications relevant to pharmaceutical.
Benefits: Our client offers a competitive salary and a comprehensive benefits package, including health, dental, and vision insurance, a 401(k) retirement plan with company match, generous paid time off, and opportunities for professional development and training. They are dedicated to fostering an inclusive and diverse workplace where every employee feels valued and can thrive. Join a company that is making a real difference and where your contributions are recognized and rewarded. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
If you are a driven and passionate professional looking for an exciting new challenge, we encourage you to apply! This is an exceptional opportunity to advance your career and work with a team of dedicated experts.
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2
Clinical Research Associate
60603 Chicago, Illinois
$75000 Annually
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client, a cutting-edge pharmaceutical company at the forefront of developing innovative therapies, is seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join their dynamic team in Chicago, Illinois, US . This role offers an exceptional opportunity to contribute directly to the advancement of new medicines by ensuring the integrity and compliance of clinical trials. The ideal candidate will have a solid understanding of clinical trial processes, strong organizational skills, and a commitment to maintaining the highest ethical and scientific standards. This position is vital to our client's mission of bringing life-changing treatments to patients worldwide.
Key Responsibilities:
Required Qualifications:
Our client offers a competitive salary, comprehensive benefits, and a collaborative work environment where your expertise will be valued and your professional growth supported. Join a team that is making a real difference in patient lives.
Key Responsibilities:
- Conduct on-site and remote monitoring visits to clinical trial sites to ensure adherence to study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements (e.g., FDA).
- Verify the accuracy, completeness, and consistency of clinical data by performing source data verification (SDV) and ensuring proper documentation.
- Review Investigator Site Files (ISF) and Essential Documents to confirm compliance and readiness for audits.
- Provide comprehensive training and support to site staff on study protocols, data collection procedures, and regulatory requirements.
- Manage site performance, identify potential issues, and implement corrective actions as needed to maintain study timelines and quality.
- Serve as the primary point of contact for assigned clinical sites, fostering strong working relationships with investigators and site personnel.
- Prepare detailed monitoring reports and follow-up letters, documenting site activities, findings, and resolutions.
- Assist with site selection, initiation, and close-out activities for clinical studies.
- Participate in investigator meetings and internal project team meetings, contributing to overall study strategy and execution.
- Stay current with evolving regulatory landscape and industry best practices in clinical research.
Required Qualifications:
- Bachelor’s degree in a life science, nursing, pharmacy, or a related healthcare field.
- Minimum of 2-4 years of experience as a Clinical Research Associate or in a similar clinical trial role within a pharmaceutical company, CRO, or academic institution.
- Thorough understanding of ICH GCP guidelines and relevant regulatory requirements (e.g., FDA regulations).
- Proven ability to manage multiple clinical sites and effectively prioritize tasks in a fast-paced environment.
- Excellent communication, interpersonal, and problem-solving skills.
- Strong attention to detail and ability to identify and resolve discrepancies in clinical data.
- Proficiency in electronic data capture (EDC) systems, clinical trial management systems (CTMS), and Microsoft Office Suite.
- Ability to travel approximately 25-40% for site visits within the region and potentially nationally.
- Certification as a Clinical Research Associate (CCRA) is a plus.
- Residing in or willing to relocate to the Chicago metropolitan area is preferred for hybrid work model.
Our client offers a competitive salary, comprehensive benefits, and a collaborative work environment where your expertise will be valued and your professional growth supported. Join a team that is making a real difference in patient lives.
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3
Clinical Research Associate
60601 Chicago, Illinois
$70000 Annually
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client, a leader in the Pharmaceutical sector, is actively seeking a highly motivated and experienced Clinical Research Associate to join their dynamic team. This pivotal role is based in Chicago, Illinois , offering an exciting opportunity to contribute to significant projects and drive impactful outcomes within a forward-thinking organization. The compensation for this position is competitive, with a $70,000 - $95,000 per annum range, reflecting our commitment to attracting top talent. We are looking for an individual who is not only proficient in their technical skills but also embodies our core values of innovation, collaboration, and excellence.
Key Responsibilities:
Qualifications:
About Our Client:
Our client is a well-established and innovative company that has been at the forefront of the pharmaceutical industry for over two decades. With a strong commitment to sustainable practices and cutting-edge technology, they have built a reputation for excellence and reliability. Their collaborative work environment fosters creativity and professional growth, encouraging employees to push boundaries and achieve their full potential. They pride themselves on a diverse and inclusive culture, believing that a variety of perspectives leads to the most groundbreaking solutions. Located in the vibrant community of Chicago, Illinois , the company offers a unique blend of urban amenities and professional opportunities, making it an ideal place to build a long-term career. Joining this team means becoming part of an organization that values its people, invests in their development, and celebrates collective success. They are dedicated to making a tangible impact in the pharmaceutical sector, constantly seeking new ways to innovate and serve their clients better. This is an unparalleled opportunity to join a company that is not just a workplace, but a community where your contributions are recognized and your career aspirations supported. They offer comprehensive benefits, professional development programs, and a supportive team structure to ensure every employee thrives.
Why Join Our Client?
Our client offers a comprehensive benefits package that includes health, dental, and vision insurance, a 401(k) with company match, generous paid time off, and professional development opportunities. They are committed to fostering a diverse and inclusive workplace where every employee feels valued and empowered to contribute their best. This role presents a significant opportunity for career advancement and impact within a leading organization. If you are a dedicated professional with a passion for pharmaceutical and meet the qualifications outlined above, we encourage you to apply. We look forward to reviewing your application and exploring how your skills and experience can contribute to our client's continued success in Chicago, Illinois . Additionally, the successful candidate will have opportunities to engage in ongoing training and development programs tailored to their career path. Our client strongly believes in nurturing talent from within and providing pathways for continuous learning and growth. They emphasize a work-life balance and offer flexible arrangements where possible, recognizing the importance of employee well-being. This is an exceptional chance to become a part of a forward-thinking organization that not only leads its industry but also cares deeply about its team members.
Key Responsibilities:
- Design, develop, and implement solutions related to pharmaceutical engineering/analysis.
- Conduct detailed research and analysis to identify trends and opportunities within the pharmaceutical sector.
- Collaborate with senior team members on complex problem-solving and innovative project development.
- Prepare comprehensive reports and presentations detailing findings and recommendations.
- Ensure all work complies with relevant industry standards and safety regulations.
- Utilize specialized software and tools pertinent to pharmaceutical for data modeling, simulation, or design.
- Participate in continuous improvement initiatives and contribute to process optimization.
Qualifications:
- Bachelor's degree in a relevant field (e.g., Pharmaceutical or a closely related discipline).
- 3-5 years of experience in pharmaceutical or a similar capacity.
- Solid understanding of best practices and current trends in pharmaceutical.
- Proven ability to manage multiple priorities and meet deadlines.
- Strong written and verbal communication skills.
- Proficiency in relevant office software (e.g., Microsoft Office Suite).
- Ability to adapt to a fast-paced and evolving work environment.
About Our Client:
Our client is a well-established and innovative company that has been at the forefront of the pharmaceutical industry for over two decades. With a strong commitment to sustainable practices and cutting-edge technology, they have built a reputation for excellence and reliability. Their collaborative work environment fosters creativity and professional growth, encouraging employees to push boundaries and achieve their full potential. They pride themselves on a diverse and inclusive culture, believing that a variety of perspectives leads to the most groundbreaking solutions. Located in the vibrant community of Chicago, Illinois , the company offers a unique blend of urban amenities and professional opportunities, making it an ideal place to build a long-term career. Joining this team means becoming part of an organization that values its people, invests in their development, and celebrates collective success. They are dedicated to making a tangible impact in the pharmaceutical sector, constantly seeking new ways to innovate and serve their clients better. This is an unparalleled opportunity to join a company that is not just a workplace, but a community where your contributions are recognized and your career aspirations supported. They offer comprehensive benefits, professional development programs, and a supportive team structure to ensure every employee thrives.
Why Join Our Client?
Our client offers a comprehensive benefits package that includes health, dental, and vision insurance, a 401(k) with company match, generous paid time off, and professional development opportunities. They are committed to fostering a diverse and inclusive workplace where every employee feels valued and empowered to contribute their best. This role presents a significant opportunity for career advancement and impact within a leading organization. If you are a dedicated professional with a passion for pharmaceutical and meet the qualifications outlined above, we encourage you to apply. We look forward to reviewing your application and exploring how your skills and experience can contribute to our client's continued success in Chicago, Illinois . Additionally, the successful candidate will have opportunities to engage in ongoing training and development programs tailored to their career path. Our client strongly believes in nurturing talent from within and providing pathways for continuous learning and growth. They emphasize a work-life balance and offer flexible arrangements where possible, recognizing the importance of employee well-being. This is an exceptional chance to become a part of a forward-thinking organization that not only leads its industry but also cares deeply about its team members.
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4
Clinical Research Associate - Midwest
60684 Chicago, Illinois
ICON Clinical Research
Posted today
Job Viewed
Job Description
As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
**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
+ Bachelor's degree in a scientific or healthcare-related field highly preferred.
+ Minimum of 2 years of experience as a Clinical Research Associate (on site monitoring experience required)
+ 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.
**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 maximise 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 website to read more about the benefits of working at ICON: 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, colour, 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 through the form below.
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.
**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
+ Bachelor's degree in a scientific or healthcare-related field highly preferred.
+ Minimum of 2 years of experience as a Clinical Research Associate (on site monitoring experience required)
+ 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.
**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 maximise 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 website to read more about the benefits of working at ICON: 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, colour, 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 through the form below.
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.
View Now
5
Clinical Research Associate II
60601 Chicago, Illinois
$80000 Annually
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client, a leading global Contract Research Organization (CRO) dedicated to advancing medical science and improving patient lives, is seeking a highly motivated and detail-oriented Clinical Research Associate II (CRA II) to join their team based out of Chicago, Illinois, US . This role is critical in supporting various phases of clinical trials, ensuring data integrity, patient safety, and adherence to regulatory guidelines. As a CRA II, you will be responsible for monitoring clinical trial sites, verifying data, and collaborating with investigators to ensure compliance with study protocols and Good Clinical Practice (GCP). This is an exciting opportunity for a professional with proven clinical research experience to contribute to groundbreaking pharmaceutical developments and make a tangible impact on global health, working within a fast-paced and intellectually stimulating environment that emphasizes scientific rigor and ethical conduct.
Key Responsibilities:
Qualifications:
Our client offers a competitive salary, comprehensive benefits package, including health, dental, and vision insurance, 401(k) with company match, generous paid time off, and significant opportunities for career growth and professional development within a dynamic and impactful industry. Join a team dedicated to bringing innovative therapies to patients worldwide.
Key Responsibilities:
- Conduct on-site, remote, and/or in-house monitoring visits to clinical trial sites according to monitoring plan, SOPs, and GCP guidelines.
- Verify informed consent processes, source documentation, and data entered into Case Report Forms (CRFs) for accuracy and completeness.
- Ensure the safety and well-being of study participants by reviewing adverse events (AEs) and serious adverse events (SAEs) and ensuring timely reporting.
- Assess site performance, identify potential issues, and implement corrective actions as needed.
- Maintain effective communication with investigators, site staff, and internal project teams.
- Provide comprehensive training and support to site staff on study protocols, data collection procedures, and regulatory requirements.
- Review and reconcile drug accountability at study sites.
- Prepare detailed monitoring visit reports and follow-up letters in a timely manner.
- Participate in site selection, initiation, and close-out activities.
- Assist with regulatory document collection and review.
- Ensure compliance with all applicable regulations, including FDA, ICH GCP, and company standard operating procedures.
- Contribute to the development and review of study-related documents such as protocols, CRFs, and informed consent forms.
- Manage study site payments and essential document collection.
- Participate in internal and external audits as required.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
- Minimum of 2-4 years of independent on-site clinical monitoring experience as a Clinical Research Associate.
- Thorough knowledge of ICH Good Clinical Practice (GCP) guidelines and relevant regulatory requirements (e.g., FDA, EMA).
- Strong understanding of the clinical trial process from study start-up to close-out.
- Excellent communication, interpersonal, and organizational skills.
- Ability to work independently, manage multiple priorities, and meet deadlines.
- Strong attention to detail and ability to perform thorough data review.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to travel frequently (up to 60-70%) to clinical sites as required.
- Problem-solving skills and ability to identify and resolve issues proactively.
- Certification as a Clinical Research Associate (CCRA) is a plus.
- Experience in specific therapeutic areas (e.g., Oncology, CNS, Cardiology) is highly valued.
Our client offers a competitive salary, comprehensive benefits package, including health, dental, and vision insurance, 401(k) with company match, generous paid time off, and significant opportunities for career growth and professional development within a dynamic and impactful industry. Join a team dedicated to bringing innovative therapies to patients worldwide.
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6
Clinical Research Associate (CRA)
60601 Chicago, Illinois
$75000 Annually
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client, a leading global contract research organization (CRO) with a strong focus on innovative pharmaceutical and biotech clinical trials, is seeking a motivated and detail-oriented Clinical Research Associate (CRA) to join their growing team in Chicago, Illinois, US . This crucial role involves monitoring and managing clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The ideal candidate will be passionate about advancing medical research and possess excellent communication and organizational skills.
Responsibilities:
Qualifications:
Our client offers a challenging and dynamic work environment, competitive compensation, comprehensive benefits, and excellent opportunities for professional growth and career advancement in the pharmaceutical industry. Join a team dedicated to bringing new therapies to patients!
Responsibilities:
- Conduct on-site, remote, and potentially hybrid monitoring visits to clinical trial sites (e.g., pre-study, initiation, routine monitoring, and close-out visits).
- Verify that the rights and well-being of human subjects are protected, and that reported trial data are accurate, complete, and verifiable from source documents.
- Review Investigator Site Files (ISF) and Essential Documents to ensure compliance with regulatory requirements, GCP, and study protocols.
- Provide comprehensive training and ongoing support to site staff on study protocols, data collection methods, and regulatory compliance.
- Ensure timely and accurate data collection and reporting, including case report forms (CRFs) and electronic data capture (EDC) systems.
- Manage and resolve data queries, deviations, and site issues promptly and effectively.
- Communicate regularly and effectively with investigators, site staff, project managers, and other study team members.
- Monitor site recruitment progress, identify potential issues, and assist sites in achieving enrollment targets.
- Prepare comprehensive visit reports and follow-up letters, documenting all activities and findings during site visits.
- Ensure that investigational products are stored, dispensed, and accounted for properly.
- Contribute to the development and review of study-related documents, such as protocols, consent forms, and monitoring plans.
- Stay current with all applicable regulatory requirements (e.g., FDA, ICH-GCP) and company Standard Operating Procedures (SOPs).
Qualifications:
- Bachelor's degree in a life science, nursing, pharmacy, or a related health field.
- Minimum of 2-4 years of experience as a Clinical Research Associate (CRA), with independent monitoring experience.
- Strong understanding of Good Clinical Practice (GCP) guidelines and relevant regulatory requirements (e.g., FDA regulations, ICH guidelines).
- Proven ability to perform various types of monitoring visits (on-site, remote, hybrid).
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Excellent written and verbal communication skills, with the ability to interact professionally and effectively with diverse stakeholders.
- Strong organizational skills, attention to detail, and ability to manage multiple priorities.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Ability to work independently and as part of a collaborative team.
- Strong problem-solving skills and the ability to identify and resolve issues proactively.
- Willingness and ability to travel approximately 30-50% for site visits (depending on hybrid model).
- Relevant certifications (e.g., ACRP, SoCRA) are a plus.
Our client offers a challenging and dynamic work environment, competitive compensation, comprehensive benefits, and excellent opportunities for professional growth and career advancement in the pharmaceutical industry. Join a team dedicated to bringing new therapies to patients!
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7
Clinical Research Associate (CRA)
60601 Chicago, Illinois
$80000 Annually
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client, a leading global Contract Research Organization (CRO) supporting groundbreaking pharmaceutical and biotechnology companies, is seeking a highly motivated Clinical Research Associate (CRA) to join their team, based out of Chicago, Illinois , with significant regional travel. This critical role involves monitoring clinical trials at investigative sites to ensure adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements. The CRA will be instrumental in the successful execution of clinical studies, contributing directly to the advancement of new therapies and treatments. If you have a strong scientific background, meticulous attention to detail, and a passion for clinical research, this is an excellent opportunity to accelerate your career in the pharmaceutical industry.
Key Responsibilities:
Qualifications:
Our client offers a competitive salary, performance bonuses, comprehensive health and wellness benefits, a robust 401(k) plan, and significant opportunities for career growth and professional development within a leading global organization. Join a team committed to advancing healthcare through rigorous clinical research.
Key Responsibilities:
- Conduct on-site, remote, and potentially centralized monitoring visits to clinical trial sites according to monitoring plans.
- Verify that the rights and well-being of human subjects are protected, and that reported trial data are accurate, complete, and verifiable from source documents.
- Ensure that the conduct of the study is in accordance with the protocol, GCP, and all applicable regulatory requirements.
- Perform source document verification, drug accountability, and review of regulatory documents at study sites.
- Communicate effectively with investigators and site staff, providing guidance and addressing issues proactively.
- Identify and resolve site-related issues and ensure timely data submission.
- Complete accurate and timely monitoring reports and follow-up letters.
- Assist in site selection and initiation processes.
- Train site staff on study protocols, GCP, and relevant procedures.
- Manage electronic trial master files (eTMF) and ensure documentation is audit-ready.
- Collaborate with internal project teams, including Clinical Project Managers, Data Managers, and Medical Monitors.
- Participate in investigator meetings and internal project team meetings.
- Stay current with industry trends, regulatory changes, and company policies.
Qualifications:
- Bachelor's degree in a life science, nursing, pharmacy, or a related health field.
- Minimum of 2-4 years of independent clinical monitoring experience (CRA experience) within a CRO, pharmaceutical company, or research site.
- Thorough knowledge of Good Clinical Practice (GCP) and relevant regulatory guidelines (e.g., FDA, ICH).
- Strong understanding of clinical trial processes and medical terminology.
- Excellent organizational skills and attention to detail.
- Exceptional verbal and written communication and interpersonal skills.
- Ability to work independently and travel extensively (up to 60-70% regional travel).
- Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and Microsoft Office Suite.
- Problem-solving aptitude and ability to adapt to changing priorities.
- Certification (e.g., CCRP) is a plus.
Our client offers a competitive salary, performance bonuses, comprehensive health and wellness benefits, a robust 401(k) plan, and significant opportunities for career growth and professional development within a leading global organization. Join a team committed to advancing healthcare through rigorous clinical research.
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Senior Clinical Research Associate
60601 Chicago, Illinois
$90000 Annually
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
About Our Client: Our client is a leading global pharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that improve the lives of patients worldwide. With a robust pipeline of novel therapies across various therapeutic areas, they are committed to scientific excellence, ethical research practices, and patient-centric solutions. They foster a collaborative and intellectually stimulating environment where groundbreaking research is translated into tangible health outcomes. Their significant presence in Chicago, Illinois, US underscores their commitment to advancing medical science in key research hubs.
The Opportunity: We are seeking a highly experienced and dedicated Senior Clinical Research Associate (SCRA) to join our Clinical Operations team in Chicago, Illinois, US . This crucial role involves overseeing and managing clinical trial sites to ensure adherence to study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. You will be instrumental in site initiation, monitoring, and close-out activities, ensuring data integrity and patient safety throughout the trial lifecycle. This is an exciting opportunity for a seasoned clinical research professional to contribute to the development of life-changing pharmaceutical products.
Key Responsibilities:
Required Qualifications:
Preferred Qualifications:
What We Offer: Our client values its employees and offers a comprehensive benefits package designed to support your well-being and professional growth. This includes competitive salary, health, dental, and vision insurance, paid time off, a 401(k) retirement plan with company match, opportunities for professional development and training, and a collaborative and supportive work culture. We believe in work-life balance and provide an environment where you can thrive both personally and professionally.
Application Process: If you are a proactive and results-oriented professional looking for a challenging yet rewarding career opportunity, we encourage you to apply. Please submit your resume and a cover letter outlining your relevant experience and why you are the ideal candidate for this role. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Join our client's team and contribute to their continued success in Chicago, Illinois, US !
The Opportunity: We are seeking a highly experienced and dedicated Senior Clinical Research Associate (SCRA) to join our Clinical Operations team in Chicago, Illinois, US . This crucial role involves overseeing and managing clinical trial sites to ensure adherence to study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. You will be instrumental in site initiation, monitoring, and close-out activities, ensuring data integrity and patient safety throughout the trial lifecycle. This is an exciting opportunity for a seasoned clinical research professional to contribute to the development of life-changing pharmaceutical products.
Key Responsibilities:
- Serve as the primary contact for clinical trial sites, providing guidance and support throughout all phases of the study.
- Conduct site qualification, initiation, interim monitoring, and close-out visits in accordance with study protocols, SOPs, GCP, and regulatory requirements.
- Verify source data, ensure accurate and complete data collection, and resolve data discrepancies.
- Monitor patient recruitment and retention strategies, identifying and addressing any challenges.
- Review Investigator Site Files (ISF) for completeness and accuracy.
- Ensure timely reporting of adverse events and serious adverse events to relevant parties.
- Provide training to site staff on study protocols, data collection procedures, and regulatory compliance.
- Collaborate with internal teams (e.g., Medical, Data Management, Regulatory) to ensure smooth trial execution.
- Identify and escalate potential issues or risks at sites and implement corrective actions as needed.
Required Qualifications:
- Bachelor's degree in a life science, nursing, pharmacy, or related health field.
- Minimum of 4-6 years of experience as a Clinical Research Associate (CRA), with a significant portion at the senior level.
- In-depth knowledge of ICH-GCP guidelines, FDA regulations, and other applicable ethical and regulatory requirements.
- Demonstrated experience in all aspects of clinical trial monitoring across various therapeutic areas.
- Strong understanding of clinical trial processes, from study start-up to close-out.
- Excellent communication, organizational, and problem-solving skills.
- Ability to travel frequently to clinical sites as required.
Preferred Qualifications:
- Master's degree or advanced certification (e.g., CCRP, CCRC).
- Experience in oncology, immunology, or neuroscience therapeutic areas.
- Experience with electronic data capture (EDC) systems.
What We Offer: Our client values its employees and offers a comprehensive benefits package designed to support your well-being and professional growth. This includes competitive salary, health, dental, and vision insurance, paid time off, a 401(k) retirement plan with company match, opportunities for professional development and training, and a collaborative and supportive work culture. We believe in work-life balance and provide an environment where you can thrive both personally and professionally.
Application Process: If you are a proactive and results-oriented professional looking for a challenging yet rewarding career opportunity, we encourage you to apply. Please submit your resume and a cover letter outlining your relevant experience and why you are the ideal candidate for this role. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Join our client's team and contribute to their continued success in Chicago, Illinois, US !
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