Clinical Research Coordinator II/III - Hospital Medicine

Cincinnati Children's•Orleans, MA

5d•$50,877 - $62,150•Onsite

About The Position

This role involves assisting in the coordination of clinical research studies within the Hospital Medicine department. The primary focus is on ensuring the smooth execution of studies by managing documentation, participant interaction, and data integrity, all while adhering to strict regulatory and ethical guidelines. The position requires a proactive approach to problem-solving and a commitment to improving patient health through research.

Requirements

High school diploma or equivalent
2 years of work experience in a related job discipline (for CRC II)
Bachelor's degree in a related field and 1 year of directly related work experience (for CRC III)
Master's degree in a related field (for CRC III)

Nice To Haves

Bachelor's degree in a related field (for CRC II)

Responsibilities

Assist in coordinating studies by preparing personnel and materials, including protocols, informed consents, amendments, and other necessary documents for IRB and Sponsor review.
Assemble lab kits and gather supplies.
Collect and label samples as instructed, and deliver or process them according to protocol, manual of operations, SOP, or other work instructions.
Ensure specimens are properly logged, handled, and stored.
Follow directions from clinical research coordinators or other staff involved in clinical research projects.
Assist other staff members and coordinators in implementing studies.
Maintain inventory of supplies and equipment.
Operate standard laboratory and research study equipment, if applicable.
Troubleshoot and correct erroneous results or equipment problems.
Identify regulatory activities to be completed and take initiative to complete them.
Coordinate and participate in the assembly of materials.
Assist in maintaining up-to-date and accurate written and electronic records and files to support clinical research activities.
Assist with audit readiness records review and preparation activities.
Assist with maintaining protocol-specific SOPs, IRB, and regulatory correspondence.
Demonstrate awareness of federal regulations, state and local law, GCP/ICH, and CCHMC policies to promote ethical practices in research involving human participants and ensure compliance.
Recognize the importance of reporting concerns of ethical and/or regulatory issues to supervisors in a timely manner.
Assist with the documentation of regulatory activities and maintenance of the regulatory binder in keeping with institution and division SOPs.
Seek out research educational opportunities.
Maintain awareness of the status of all active studies.
Identify potentially eligible participants.
Coordinate, plan, and execute study visits, and provide instructions and reimbursement to participants.
Approach potential participants and families in a professional manner.
Conduct pre-consent screening procedures according to protocol specifications to determine eligibility.
Review consent forms with participants and provide time for them to consider study participation.
Execute the informed consent process according to Good Clinical Practices (GCP), CCHMC procedures, and other applicable policies.
Communicate with participants' clinical teams regarding study participation as indicated by protocol and/or manual of operations.
Document in applicable systems (tracking, electronic health, etc.) participants approached, screened, and enrolled in the study.
Communicate challenges with recruitment and retention to study leadership.
Provide recommendations to improve recruitment and retention to study leadership.
Assist with organizing and filing all correspondence.
Refer questions and issues that arise during study conduct to the appropriate research team member.
Maintain awareness of study-related issues involving investigators, sponsors, coordinating centers, study coordinators, clinical teams, managers, and other institutions.
Maintain relationships with participants and develop rapport.
Provide input to division discussions related to clinical research studies.
Participate in meetings, discussions, and activities designed to improve organizational performance by recommending areas or approaches for improving study conduct.
Complete Case Report Forms (CRFs) and source documentation in compliance with all applicable guidelines for human research.
Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
Enter data into various auditable databases or electronic data-capture systems.
Maintain internal record-keeping system(s) in conjunction with study team members.
Ensure accuracy of documentation from sources.
Perform quality checks to ensure accuracy of data.
Review reports, tables, and listings.
Support the data-management process for clinical research projects, including addressing data queries from data managers, project statisticians, and sponsors.