136 Clinical Research jobs in Chicago

• 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.

• 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.

• 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).

• 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.

• 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.

• 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.

• 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).

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

Our client is seeking a Clinical Research Coordinator responsible for day-to-day management and coordination of multiple clinical trials. You will ensure the safety of participants and adherence to protocols and regulations.

Key Responsibilities

• Manage and coordinate 2-3 clinical trials at once.
• Oversee 10-20 patient visits per week.
• Ensure safety of participants throughout the trials.
• Ensure adherence to protocols and regulations.

Department: MED-Clinical Trials Unit
Salary/Grade: EXS/8

The target hiring range for this position will be $70,017 - $87,522 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:

Under general supervision and according to standard practice or general instruction, directly supports the research initiatives of the Bluhm Cardiovascular Institute Clinical Trials Unit. Collaborates with the physicians and clinical team in implementing investigator-initiated, industry-sponsored, as well as federally funded protocols, including multi-center clinical trials. Responsible for coordinating research studies from the initiation of the study to its completion, including but not limited to implementing clinical and non-clinical study procedures. Conducts protocol eligibility assessments, provides ongoing clinical and laboratory evaluation of study subjects, collects data and maintains confidential research records, provides study patient management according to protocol and regulatory requirements. On site activity is expected 4-5 days per week.

Please note: Supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures. EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications. Work may extend beyond the central NU/NM campus to NM affiliates for targeted initiatives.

Specific Responsibilities :

• Recruit, screen, enroll, and follow study participants over the course of a study as outlined in assigned cardiovascular research protocols. The study nurse will perform physical examinations on potential participants prior to randomization.
• Coordinates the implementation of clinical protocols at Northwestern and subsites. Works with sponsors, study staff, laboratory staff, data managers, pharmacists, clinic staff, investigators, and other departments to develop and implement protocol-specific standard operating procedures. Coordinates clinical and non-clinical study start-up activities including organization of study medical records and coordination of required laboratory and clinical evaluations.
• Performs patient recruitment and evaluates subjects for potential study qualification in accordance with protocol eligibility criteria, including: medical record review, interviewing, clinical and laboratory evaluations, obtaining informed consent. The study nurse will collect information necessary for reporting serious adverse events (including details of the hospitalization)
• Provides ongoing monitoring of patients in clinical research protocols. Conducts medical and social histories, clinical evaluations and orders laboratory and other procedures as required by protocol. Records/abstracts data in study source documents and on case report forms. Schedules and tracks study visits. Ensures that study drug is properly dispensed to patient and provides patient education regarding medications and laboratory results. Also oversee accountability of investigational devices and provides associated education. Reviews clinical and laboratory data on study patients. Notifies principal investigator of any abnormal values and ensures follow-up and reporting of adverse events in accordance with regulatory requirements.
• Responsible for ongoing data collection and maintenance of confidential records. Reviews study forms, files and reports for completeness, accuracy, consistency and compliance (quality control). Ensures appropriate and timely transmission of clincal data to data management center. Responds in a timely manner to requests for data clarifications and queries. The study nurse will assemble medical information (results of physical examination, ECG, vital signs) for review and presentation prior to randomization. The study nurse will review research billing

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• BS in nursing with a minimum of 3 years in an administrative or clinical research role in an academic or industry environment or the equivalent combination of education and experience where similar knowledge, skills, and abilities may be acquired.
• RN Licensure in Illinois required.

Minimum Competencies: (Skills, knowledge, and abilities.)

• Ability to work on multiple projects simultaneously.
• Strong computer skills to include advanced use of Word and Excel software programs, internet, and email.
• Ability to identify research and solve problems.
• Must possess ability to articulate and clearly communicate study information to patients and other health care professionals
• Attention to detail and highly organized.
• Excellent clinical assessment skills.
• Able to make decisions independently and yet must be team oriented.

Preferred Qualifications:

• Master of Science degree
• Cardiovascular experience

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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