Job Description

Role : Clinical Research Coordinator – Allergy/Immunology

Location : Onsite - Maryville, IL 62062

• Relocation candidates will NOT be considered for this position
• Role is 100% onsite, there is no opportunity for hybrid or remote work at this time

Therapeutic Area : Allergy/Immunology

Employment Type : Position is a contract, project based support role - current contract duration is 6-12 month with potential to extend

Schedule/ Shift:

• Role is starting at 20 hours a week during study start up, then full time 40 hours a week once start up is completed
• On-Site Monday – Friday, during daytime business hours

Position Summary:

We are seeking a highly motivated and experienced Clinical Research Coordinator (CRC) to join our Allergy/Immunology research team. The successful candidate will be responsible for the day-to-day coordination and management of clinical trials, ensuring strict adherence to regulatory guidelines and study protocols. This position demands initiative, professionalism, and the ability to work independently with minimal supervision, especially during study start-up and regulatory preparation.

Key Responsibilities:

• Coordinate and execute clinical research studies from start-up through close-out, including feasibility, site selection, regulatory submissions, subject recruitment, and data collection.
• Serve as the primary liaison with central IRBs, managing submissions, renewals, amendments, and responses to queries.
• Independently manage all phases of clinical trials, maintaining compliance with Good Clinical Practice (GCP) and institutional/SOP standards.
• Recruit, screen, consent, and enroll study participants per protocol.
• Perform and document phlebotomy procedures and handle biological specimens per IATA shipping standards.
• Maintain regulatory and study documentation including case report forms (CRFs), electronic data capture (EDC) systems, and source documents.
• Monitor and report adverse events; ensure accurate and timely documentation of protocol deviations.
• Organize and conduct pre-study site initiation visits, interim monitoring visits, and close-out visits with sponsors and CROs.
• Handle investigational product accountability and coordinate with clinical pharmacies as needed.
• Educate participants on study protocols, medications, and visit schedules.
• Ensure timely resolution of sponsor and monitor queries, audits, and action items.
• Other responsibilities as applicable and assigned.

Required Qualifications:

• Bachelor’s degree in life sciences, nursing, or related field (or equivalent clinical experience).
• Minimum 3 years of clinical research experience, preferably in Allergy/Immunology treatment area.
• Proven study start-up experience, including central IRB submission and regulatory binder creation.
• Strong communication, organizational, and problem-solving skills.
• Current GCP and IATA certifications.
• Proficient in phlebotomy, including venipuncture and specimen processing.
• Demonstrated ability to work independently and manage multiple clinical trials concurrently.
• Strong knowledge of clinical research processes, FDA regulations, and IRB compliance.
• Experience using CTMS, EDC systems, and Microsoft Office Suite.

Preferred Qualifications:

• Certified Clinical Research Coordinator (CCRC) or equivalent credential.
• Experience with Phase I–IV industry-sponsored trials.
• Familiarity with electronic health record (EHR) systems.

Work Environment & Physical Requirements:

• This role may require prolonged sitting, standing, or walking.
• Ability to lift up to 25 lbs (e.g., lab supplies or shipping containers).
• Flexibility to work evenings or weekends as needed for participant scheduling or study timelines.

Application Instructions:

• Interested candidates should submit a resume, and copies of GCP and IATA certifications.
• Documentation of phlebotomy training and experience with study start-up may be requested during the interview process.

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