Clinical Research Coordinator II

Carle Health•Peoria, IL

About The Position

Promotes good clinical practices in the conduct of clinical investigations through in-depth knowledge of federal regulations and guidance on clinical trials and human subject protection. Ensures compliance with protocol and regulatory requirements while collecting, recording, and maintaining data and source documentation. Reviews technical operations to ensure processes, protocols, and procedures are quality controlled and functioning to standards. Ensures study activities follow Good Clinical Practices (GCP) and applicable local, state, and federal laws, regulations, guidance, and policies and procedures established by Institutional Review Boards (IRBs), the Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH). Coordinates research studies, maintains study documentation and data, supports subject recruitment and follow-up, communicates with subjects and research partners, and contributes to protocol planning and assessment. The compensation range is $24.86 to $41.52 per hour. Carle Health offers a comprehensive benefits package; details are available at careers.carlehealth.org/benefits.

Requirements

High school diploma or GED.
Bachelor's degree in a related field.
Obtain Certified Clinical Research Coordinator (CCRC) certification through the Association of Clinical Research Professionals (ACRP) within 2.5 years.
Knowledge of Good Clinical Practices and applicable clinical research regulations and guidance.
Ability to coordinate clinical research studies and manage study data, source documentation, and regulatory requirements.

Responsibilities

Coordinate assigned research studies at all levels of acuity within the scope of licensure.
Plan and design forms and source-document tools for protocol implementation; document protocol deviations and exemptions.
Obtain and review original source documents; abstract data from medical records and other clinical notes; accurately enter data into case report forms and electronic systems.
Maintain source documentation and study files, resolve data queries, correct case report forms, and prepare records for sponsor or audit review.
Maintain study article dispensing logs and transmit data as requested.
Monitor enrollment goals and adjust recruitment plans; maintain screening and enrollment logs and document patient participation.
Review inclusion and exclusion criteria with investigators, verify source documents, and ensure screening, eligibility, and enrollment procedures are completed.
Review protocols, informed consent forms, and follow-up procedures with potential subjects; assess their ability and willingness to participate; obtain and document informed consent before study procedures.
Follow protocol randomization procedures and ensure study article administration, subject scheduling, specimen collection, and required batching and shipping.
Review subject diaries and questionnaires and assess compliance with study articles and follow-up visits.
Recognize and report common laboratory values and alert the investigator and sponsor as appropriate.
Protect patient privacy, securely store study documents, and appropriately dispose of sensitive documents.
Maintain sponsor and CRO contact lists; educate patients on medication or device use and provide information about reporting study-related events.
Provide management feedback on integrating research operations into clinics and establish mechanisms to contact subjects about follow-up visits and new information.
Document telephone communications, contact primary care providers about patient enrollment and study progress, and regularly meet with investigators and the research team.
Submit protocol amendments and progress reports to the IRB and notify the investigator, sponsor, and IRB of adverse events within protocol timeframes.
Schedule and participate in sponsor monitoring visits and discuss case report form completion, query resolution, and protocol-related issues.
Clarify study questions and concerns with investigators and sponsors; prepare and submit regulatory and IRB documents.
Integrate proposed clinical trials with ongoing research activities, attend investigator meetings, and confirm required contacts and IRB approvals are in place before study initiation.
Complete sponsored-protocol training, including GCP, EDC, IVRS, and IRB training.