Clinical Study Coordinator

About the role

The successful candidate will play a key role in supporting oncology clinical trials, ranging from First-in-Human to Phase III studies, as well as Therapeutic Investigator-Initiated Trials (IITs).

Responsibilities

• Career: Clinical Study Coordinator
• Hours: Monday – Friday, 7:30 AM – 4:00 PM
• Primary Reporting Location: Onsite at Zion, IL (Not a remote position)
• Travel Requirement: Must be able to travel to North Shore and Downtown locations as needed. Travel to other locations is less than 20% of the role.
• Job Summary: Under the supervision of the director of Clinical Research and/or Research Manager, the Clinical Study Coordinator ensures strict adherence to federal regulations, institutional policies, and standard operating procedures (SOPs), while maintaining accurate and timely data collection and documentation.
• Key Responsibilities:
• Coordinate therapeutic clinical trials across various oncology disease areas.
• Ensure compliance with study protocols, regulatory requirements, and institutional guidelines.
• Collaborate with investigators on subject recruitment, pre-screening, and enrollment.
• Present study information to participants, obtain informed consent, and coordinate clinical care.
• Monitor and document subject condition changes and adverse events.
• Maintain regulatory documentation and participate in off-site meetings as needed.
• Provide education and training to clinical staff on research protocols and procedures.
• Develop study-specific tools and manage biological specimen collection, processing, and shipping.
• Maintain inventory and ensure equipment certifications are current.

Qualifications

• Education: Bachelor’s degree in science, Health, or a related field. In lieu of a degree, 3 additional years of relevant experience may be considered.
• Experience: Minimum of 2 years in clinical research or related clinical experience. Preferred: 3+ years in oncology research or experience with Phase I trials.

Required Certifications

• Required within 1 month of hire: IATA, GCP, HSP, and BLS.
• Required within 1 year of hire: ACRP or SOCRA certification.

Skills and Abilities

• Strong technical and critical thinking skills.
• Excellent problem-solving and decision-making capabilities.
• Ability to work independently and exercise sound judgment.
• Effective communication and interpersonal skills.
• Ability to mentor and train clinical support staff.