Study Start Up Associate Jobs in Berwyn, IL (NOW HIRING)

Cedar Crosse Research Center is an independent Phase I–IV clinical research center in Chicago, IL. For over 30 years and 550+ clinical trials, we've been a leading Midwest site conducting research across diabetes, hypertension, obesity, migraine, high cholesterol, heart disease, vaccines, kidney disease, pain, and more. We partner with pharmaceutical, biotech, and CRO sponsors nationwide to bring new treatments safely and ethically to the patients who need them.

The Role

We're hiring a full-time, on-site Sub-Investigator / Principal Investigator to join our clinical team. This is one posting covering two possible entry points — where you land depends on your experience:

• Principal Investigator – for candidates with 5+ years of clinical research experience as a PI or Sub-Investigator, an active/unrestricted Illinois medical license (MD or DO), and the qualifications to hold ultimate regulatory and medical responsibility for assigned studies.
• Sub-Investigator – for candidates newer to clinical research (including licensed MD/DO, NP, or PA candidates without prior PI experience) who will work under the direct supervision of a Principal Investigator while building toward that role.

Schedule is Monday–Friday, full-time, on-site at our Chicago research center. No nights, weekends, or on-call rotation.

Study conduct & compliance

• Conduct all assigned studies strictly in accordance with the approved research protocol, the sponsor's requirements, and applicable FDA regulations.
• Maintain full compliance with Good Clinical Practice (GCP), 21 CFR, HIPAA, and all IRB/EC requirements throughout each trial.
• Minimize risk to research subjects through sound clinical judgment and adherence to protocol-defined procedures.

Participant care & safety

• Screen, medically evaluate, and determine eligibility of prospective study volunteers.
• Obtain and document informed consent in accordance with company policy and federal regulation.
• Perform physical exams, take medical histories, order and interpret diagnostic/laboratory tests, and order protocol-specified medications or treatments.
• Monitor participants for safety throughout the study, identify and manage acute and non-acute clinical issues, and provide medical follow-up as needed.
• Promptly identify, document, and report adverse events and serious adverse events to the Principal Investigator, sponsor, IRB, and FDA as required.

Documentation & data integrity

• Maintain accurate, timely, and complete source documentation, progress notes, and case report forms for every subject encounter.
• Monitor collected data to ensure accuracy, subject confidentiality, and audit-readiness.
• Respond promptly to sponsor, CRA, and auditor information requests.

Team & sponsor collaboration

• Collaborate closely with study coordinators, research nurses, regulatory staff, and sponsor/CRO representatives to ensure successful trial execution.
• Participate in study start-up visits, monitoring visits, investigator meetings, and audits as needed.
• Provide education and guidance to study staff and (for the PI role) mentor Sub-Investigators and clinical research coordinators.
• Attend continuing education and GCP/regulatory training as required to maintain credentialing.

Principal Investigator–specific obligations (in addition to the above)

• Hold ultimate responsibility for the scientific and ethical conduct of each assigned study, including equitable subject selection and overall protocol integrity.
• Serve as the primary point of accountability to sponsors, CROs, the IRB, and regulatory agencies for the site's trials.
• Oversee and delegate responsibilities to Sub-Investigators and study staff, ensuring all delegated tasks are performed within scope of license/certification.
• Sign and take responsibility for required regulatory documents (FDA Form 1572, financial disclosures, protocol signature pages, etc.).

Principal Investigator track

• MD or DO with an active, unrestricted Illinois medical license (or ability to obtain).
• Minimum 5 years of clinical research experience as a Principal Investigator or Sub-Investigator.
• Board certification in relevant specialty preferred.
• Working knowledge of FDA regulations, ICH-GCP, and IRB processes.
• Strong leadership, communication, and organizational skills.

Sub-Investigator track (no prior PI experience required)

• MD, DO, NP, or PA with an active, unrestricted Illinois license.
• Prior clinical research experience preferred but not required — training provided for candidates with strong clinical/patient-care backgrounds.
• Willingness to complete GCP certification and sponsor-required training prior to/at start of employment.
• Comfort performing physical exams, drawing on clinical judgment for acute/non-acute issues, and working within a protocol-driven environment.

Both roles

• Proficiency with Microsoft Office; ability to learn clinical trial management (CTMS) and electronic data capture (EDC) systems.
• Excellent written and verbal communication skills.
• Ability to lift/move up to 50 lbs, stand/walk for extended periods, and handle biological materials as required by lab procedures.