Apply on Employer Site

Rush University Medical Center · 4 hours ago

Clinical Research Coordinator II-23400

Chicago, IL

Full-time

Onsite

Entry, Mid Level

$27.47/hr - $38.81/hr

2+ years exp

Rush University Medical Center is seeking a Clinical Research Coordinator II who will independently coordinate clinical research studies across various disciplines. The role involves participant recruitment, data management, regulatory documentation, and ensuring compliance with research protocols.

Clinical TrialsEducationHealth CareMedicalTraining

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

Qualification

Clinical trial coordinationRegulatory knowledgeRegulatory complianceProject managementCommunication skillsParticipant interactionVendor interactionRelevant certificationProblem-solvingDetail-orientedTeamworkFlexibilityTime management

Required

Bachelor's degree

2+ years of experience coordinating clinical trials

Independent site management experience

3 years total experience in coordinating clinical trials with increasing complexity (in lieu of a degree)

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

Preferred

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)