Carle Health · 22 hours ago
Clinical Research Coordinator II
Peoria, IL
Full-time
Onsite
Mid Level
$24.60/hr - $41.08/hrCarle Health is a healthcare system with nearly 16,600 team members, and they are seeking a Clinical Research Coordinator II. This role is responsible for promoting good clinical practices in the conduct of clinical investigations, ensuring compliance with regulations, and managing study-related documentation and processes.
Hospital & Health Care
No H1B
Responsibilities
Coordinates assigned Research Studies at all levels of acuity within the scope of Licensure
Plans and designs new forms/source document tools to be used in protocol implementation
Documents protocol deviations and exemptions
Obtains and reviews original source documents (e.g., recordings, scans, tests, procedure results) as needed
Abstracts data from medical records, clinic, consultation, and referral notes to study forms and flowsheets
Records accurate and timely data onto case report forms
Maintains source documentation for all case report entries, as applicable
Keys data for electronic submission
Transmits data via fax, mail or electronically as requested
Corrects and edits case report form entries as appropriate
Resolves data queries
Completes and maintains the study article dispensing log
Maintains files of all study-related documentation
Prepares case report forms for sponsor/audit review
Collects source documents for sponsor/audit review PARTICIPATES IN SUBJECT RECRUITMENT, ENROLLMENT, AND FOLLOW-UP PROCEDURES BY:
Monitors enrollment goals and modifying recruitment plan as necessary
Maintains patient screening/enrollment logs
Follows patient population clinically and maintains documentation supporting study
Reviews inclusion/exclusion criteria with investigator to assure subject eligibility
Reviews and verifies required source documents in subject's medical record to confirm study eligibility
Assures that all screening, eligibility, and enrollment procedures are performed
Reviews the protocol, informed consent form, and follow-up procedures with potential study subjects
Conducts interviews to assess the subject's ability and willingness to follow and complete study procedures and visits
Obtains informed consent from research subjects prior to any study-related procedures and documenting appropriately
Follows randomization procedures as per protocol
Assures administration of study article as appropriate
Schedules subjects for follow-up visits
Reviews diaries and questionnaires completed by subject
Ensures appropriate specimen collection, batching and shipping as required
Assesses subject compliance with the test article and follow-up visits
Recognizes and reporting common laboratory values and alerts to investigator and sponsor
Protects patient privacy during initial and follow-up interviews
Secures safe storage of study-related documents
Assures appropriate disposal of sensitive documents COMMUNICATES EFFECTIVELY WITH SUBJECTS, RESEARCH TEAM, IRB, AND SPONSOR BY:
Maintains a list of sponsor/CRO contacts for each protocol
Educate patients on how to use medication or device in study
Provide management feedback on how to integrate research operations in clinics for most effective workflow
Provides subjects with information about reporting study-related events to research team
Establishes a mechanism to contact subjects for follow-up visits, new information, etc
Utilizes a phone log to document telephone communications
Contacts primary care providers to discuss/inform of patient enrollment and study progress
Meets regularly with investigator and research team to discuss subject participation and protocol progress
Submits protocol amendments and progress reports to IRB in required timeframes
Completes timely notification of the investigator, sponsor, and IRB of adverse events as outlined in the protocol
Schedules sponsor monitoring visit
Meets With Monitors During Routine Visits To Discuss Case Report Form Completion, Query Resolution, And Other Protocol-related Issues. PARTICIPATES IN PROTOCOL ASSESSMENT/PLANNING BY
Lists and clarifies questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations, and study procedures
Prepares and submits regulatory documents to sponsor (e.g. Form FDA 1572, laboratory certification and normal values, curriculum vitae etc.)
Prepares and submits institutional review board documents
Integrates proposed clinical trial with current research activities
Attends and participates in investigator meetings
Confirms that contact, IRB approval of protocol and informed consent have been received prior to study initiation
Completes Sponsored protocol training including (GCP, EDC, IVRS, IRB, …)
Qualification
Required
Certified Clinical Research Coordinator (CCRC) within 2.5 years - Association of Clinical Research Professionals (ACRP)
H.S. Diploma/GED
Bachelor's Degree: Related Field
Benefits
Comprehensive benefits package
Company
Carle Health
Carle Health is a vertically integrated system with a bold but simple mission: to be the trusted partner in all healthcare decisions for everyone who depends on it.
Founded in 1946
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Matthew Kolb
Executive Vice President, Chief Operating Officer
Dawn Walden
Senior Vice President, Chief Revenue Cycle Officer
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