Clinical Research Coordinator II - Cancer Center - Aurora, IL

Rush University Medical Center•Chicago, IL

29d•$27 - $39•Onsite

About The Position

The Clinical Research Coordinator II (CRC II) independently coordinates assigned aspects of clinical research studies across a range of disciplines. Responsibilities include participant recruitment and retention, study data management, regulatory documentation submission and maintenance, communication with sponsors and institutional stakeholders, and monitoring of study compliance. The CRC II executes study protocols with increasing independence, identifies and resolves routine operational issues, contributes to process improvements, and may assist in mentoring less experienced staff. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.

Requirements

Bachelor's degree
2+ years of experience coordinating clinical trials
Independent site management experience
OR
3 years total experience in coordinating clinical trials with increasing complexity
Regulatory Knowledge - Understands Good Clinical Practices (GCP) and proper research documentation.
Regulatory Compliance - Knows the basic rules and guidelines from NIH and FDA that apply to research.
Project & Time Management - Can manage timelines, keep track of tasks, and handle several study activities at once.
Problem-Solving & Judgment - Can figure out solutions when challenges come up and make thoughtful decisions.
Detail & Organization - Pays close attention to detail and keeps study data and records well organized.
Participant & Vendor Interaction - Builds trust with participants and communicates respectfully with sponsors and outside partners.
Communication Skills - Speaks and writes clearly when sharing information with research teams, participants, or external groups.
Teamwork - Works well with other staff and helps solve problems as part of the team.
Flexibility - Willing to work evenings or weekends if the study requires it.
Travel Readiness - Able to travel locally or nearby for study visits, participant support, or training.

Nice To Haves

2-5 years' experience in clinical research conduct, regulatory management, or research administration
Relevant certification strongly preferred (Certified Clinical Research Professionals (CCRP)
Certified Clinical Research Associate (CCRA)
Certified Clinical Research Coordinator (CCRC), OR
Certified IRB Professional (CIP)

Responsibilities

Coordinates all aspects of the study including recruitment, consent, screening, scheduling, tracking, and provides study updates to study participants throughout the conduct of the study.
May collect and enter data into study case report forms and/or electronic data capture system and respond to queries in a timely manner.
Independently submits or partners with a regulatory coordinator to submit study related documents, study protocols, and study protocol amendments to the IRB per policy and procedure, with increasing autonomy over time to prepare for independent regulatory management responsibilities.
Ensures procedural documentation is accurate, complete, and in compliance with institutional, local, state, and federal guidelines and regulations related to clinical research.
Verifies and ensures that data is consistent with 100% of source documentation before entry into case report forms and electronic data capture systems to support accuracy, timeliness, and audit readiness.
May collect, process, and ship potentially biohazardous specimens.
May administer more complex structured tests and questionnaires according to research study protocols, including providing protocol-specific education to participants regarding procedures and expectations. May utilize study-related technology and equipment as part of assessment procedures.
Provides ongoing study status updates, responds to questions, and may create summary report(s) for distribution to the PI, Administrator, department stakeholders, Sponsor, and Compliance throughout the conduct of the study.
Organizes and participates in auditing and monitoring visits.
Monitors participant interactions for protocol deviations, adverse events (AEs), and serious adverse events (SAEs), and reports findings per institutional and regulatory guidelines.
Partners with PI(s), sponsor, compliance, clinical staff, and manager to identify and improve more complex processes as it relates to the conduct of the research study.
May provide oversight, training, and coaching to less experienced staff.
Other duties as assigned.