Provide support for clinical trials, including design preparation, site evaluations, study monitoring, report generation, and regulatory document management.
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
Benefits
Dental, Medical, Vision and 401K
Similar Jobs
Healthtech • Professional Services • Biotech • Pharmaceutical
The Clinical Research Associate 1 provides support for clinical trials, assists in protocol design, site evaluations, monitoring, and regulatory document preparation.
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Clinical Research Associate will monitor sites for compliance, manage documentation, ensure patient safety, facilitate training, and oversee drug accountability in oncology trials.
Top Skills:
CtmsEtmfIch-Gcp
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Senior Clinical Research Associate monitors clinical trials, ensures compliance with regulations, mentors junior staff, and maintains quality and integrity of studies.
Top Skills:
Clinical Trial ManagementFda RegulationsIch/Gcp Guidelines
What you need to know about the Chicago Tech Scene
With vibrant neighborhoods, great food and more affordable housing than either coast, Chicago might be the most liveable major tech hub. It is the birthplace of modern commodities and futures trading, a national hub for logistics and commerce, and home to the American Medical Association and the American Bar Association. This diverse blend of industry influences has helped Chicago emerge as a major player in verticals like fintech, biotechnology, legal tech, e-commerce and logistics technology. It’s also a major hiring center for tech companies on both coasts.
Key Facts About Chicago Tech
- Number of Tech Workers: 245,800; 5.2% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: McDonald’s, John Deere, Boeing, Morningstar
- Key Industries: Artificial intelligence, biotechnology, fintech, software, logistics technology
- Funding Landscape: $2.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Pritzker Group Venture Capital, Arch Venture Partners, MATH Venture Partners, Jump Capital, Hyde Park Venture Partners
- Research Centers and Universities: Northwestern University, University of Chicago, University of Illinois Urbana-Champaign, Illinois Institute of Technology, Argonne National Laboratory, Fermi National Accelerator Laboratory
