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Clinical Operation Associate Jobs in Chicago, IL

Clinical Research Associate / Sr Clinical Research Associate - Oncology - Central/East region ICON ... May serve as a subject matter expert for clinical operations on monitoring related activities (Sr ...

Clinical Associate

Chicago, IL ยท On-site

$22 - $30/hr

The Clinical Associate is a vital member of our healthcare team, performing a wide range of ... Oversee laboratory operations, including specimen collection, lab orders, and processing.

The Clinical Associate is a vital member of our healthcare team, performing a wide range of ... Oversee laboratory operations, including specimen collection, lab orders, and processing.

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Clinical Operation Associate information

See Chicago, IL salary details

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How much do clinical operation associate jobs pay per hour?

As of May 28, 2026, the average hourly pay for clinical operation associate in Chicago, IL is $32.49, according to ZipRecruiter salary data. Most workers in this role earn between $21.78 and $42.84 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Clinical Operation Associate, and why are they important?

To thrive as a Clinical Operation Associate, you need a solid understanding of clinical trial processes, regulatory guidelines, and a relevant degree in life sciences or a health-related field. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC), and basic project management tools is typically required. Strong organizational skills, attention to detail, and effective communication are standout soft skills in this role. These capabilities ensure regulatory compliance, efficient trial execution, and seamless coordination among stakeholders in clinical research settings.

What are some common challenges Clinical Operation Associates face when coordinating clinical trials, and how can they be managed?

Clinical Operation Associates often encounter challenges such as managing tight timelines, ensuring regulatory compliance, and coordinating communication among diverse stakeholders. Balancing multiple study sites and adapting to protocol amendments can also add complexity. Effective organization, proactive communication, and a strong understanding of clinical trial processes are key to overcoming these hurdles. Collaborating closely with site staff, clinical monitors, and project managers helps ensure that issues are identified early and addressed promptly, contributing to smoother trial operations.

What are Clinical Operation Associates?

Clinical Operation Associates are professionals who support the planning, coordination, and execution of clinical trials within pharmaceutical, biotechnology, or clinical research organizations. They help ensure that clinical studies adhere to regulatory guidelines, timelines, and quality standards. Their responsibilities often include documentation management, assisting with trial site communications, tracking study progress, and supporting the clinical operations team with administrative tasks. Clinical Operation Associates play a vital role in the smooth running of clinical trials, contributing to the development of new medical treatments.
What are the most commonly searched types of Clinical Operation jobs in Chicago, IL? The most popular types of Clinical Operation jobs in Chicago, IL are:
What are popular job titles related to Clinical Operation Associate jobs in Chicago, IL? For Clinical Operation Associate jobs in Chicago, IL, the most frequently searched job titles are:
What job categories do people searching Clinical Operation Associate jobs in Chicago, IL look for? The top searched job categories for Clinical Operation Associate jobs in Chicago, IL are:
What cities near Chicago, IL are hiring for Clinical Operation Associate jobs? Cities near Chicago, IL with the most Clinical Operation Associate job openings:
Senior Clinical Research Associate (Fixed Term)

Senior Clinical Research Associate (Fixed Term)

Advanced Clinical

Chicago, IL โ€ข On-site

Full-time

Posted 17 days ago


Job description

A Senior Clinical Research Associate (Sr. CRA) is responsible for:
  • Conducting monitoring activities at assigned clinical trial site(s)
  • Verifying the adequacy, reliability, and quality of data collected at clinical sites
  • Ensuring the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with applicable regulatory requirements in the assigned countries
  • Subject safety, data integrity, and protecting the subject confidentiality
  • Mentoring CRAs and other Clinical Operations (CO) staff
  • Anticipating, recognizing and resolving issues in the served study sites and may oversee such activities of CRA/other CO staff

ESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Follows and ensures assigned studies are conducted in compliance with the currently approved Protocol(s)/Amendment(s), Standard Operating Procedures (Advanced Clinical or Sponsor SOPs), Code of Federal Regulations (CFR), Good Clinical Practice (ICH GCP), and local or country regulations
  • Participates in Investigator feasibility and selection process by contacting sites to obtain feasibility information
  • Conducts site qualification (pre-study), site initiation, routine interim and close-monitoring visits for assigned studies and sites
  • Travels to research sites to conduct on-site visits as required
  • Prepares site submissions to the Independent Ethics Committees (central and local) and to Competent/Regulatory Authorities, when applicable
  • Assists with the development of Investigator and Institution contracts and budget templates, negotiates site budgets, and arranges site payments, when applicable
  • Attends internal CRA Team meetings and participates in study team and sponsor meetings, as required
  • Participates in Investigator meetings and assists with meeting preparation, when required
  • Conducts monitoring visits per the monitoring visit frequency defined in the Monitoring Plan or as instructed by the study team and confirms visit attendance by sending visit confirmation letters to site staff
  • Manages his/her own monitoring visit schedule for all assigned sites in accordance to the Monitoring Plan or the study needs
  • Proactively schedules appointments to meet with site staff during monitoring visits
  • Verifies that all delegated study staff at assigned sites are trained/certified and maintain compliance with requirements of the study protocol, informed consent process, data collection requirements, Investigational Product/Investigational Medical Device (IP/IMP) accountability/supply management, and safety reporting requirements
  • Ensures the adequacy, reliability, and quality of all study data at assigned sites by performing source data review, source document verification, query resolution, and regulatory document and investigational product review
  • Ensures that each assigned site is equipped with all necessary study equipment and supplies, and that the procedures (including sampling, processing, storage and shipment logistics) are appropriately adhered to
  • Ensures subject safety, data integrity, and subject confidentiality
  • Writes monitoring visit reports (MVRs) and sends site visit follow-up letters (FUL) as outlined in SOPs and study Monitoring Plans
  • Routinely reviews the Investigator Site File (ISF) and the Pharmacy Binder (if applicable) for accuracy, timeliness and completeness
  • Reconciles the Investigator Site File (ISF) with the Trial Master File (TMF) and uploads any documents obtained during monitoring visits to the TMF to ensure inspection readiness at all times
  • Maintains awareness of key study performance indicators via regular communication with the site and clinical study team including Investigators, study coordinators, pharmacist, and other study personnel
  • Discusses study status, timelines, patient recruitment, screening, enrollment, and retention efforts, ongoing patient status, IP/IMP supplies, study supplies, and any further requests or issues with each assigned site
  • Conducts routine follow-up of open action items between monitoring visits to ensure timely closure
  • Creates and maintains study/site trackers to successfully conduct monitoring visits
  • Provides project specific training, mentoring, and/or co-monitoring with new CRAs.
  • Completes assigned function area and study specific trainings
  • Performs other duties as assigned per Advanced Clinical needs

QUALIFICATIONS:
  • Must have 3-5 years of clinical monitoring experience
  • The ideal candidate should have a Bachelor's degree in life sciences, a nursing degree, or be able to demonstrate equivalent experience
  • Ability to travel up to an average of 80%, depending on project needs
  • Must demonstrate clear understanding of the drug development process, clinical monitoring, and safety and regulatory requirements
  • Must have excellent verbal and written communications skills as well as excellent interpersonal, presentation, and organizational skills with demonstrated attention to detail
  • Must be able to work independently and in a team environment
  • Must be computer literate with proficiency in MS Office including Outlook, Word, Excel, and PowerPoint as a minimum
  • This role may be office and/or home-based however regular infrequent visits to a Company office will also be required.