Clinical Research Coordinator - Pharmacology

Cincinnati Children's

7d•Onsite

About The Position

This position assists in coordinating studies by preparing personnel and materials, preparing protocols, informed consents, amendments, and other necessary documents for review by the IRB and Sponsor. The role involves assembling lab kits, gathering supplies, collecting and labeling samples, and processing them in accordance with protocol. The Clinical Research Coordinator ensures specimens are properly logged, handled, and stored, and follows the direction of senior staff. They assist other staff members and coordinators in implementing studies, maintain inventory of supplies and equipment, and operate standard laboratory and research study equipment. Troubleshooting and correcting erroneous results or equipment problems are also part of the responsibilities. The role requires identifying and completing regulatory activities, coordinating and participating in the assembly of materials, and assisting in maintaining accurate written and electronic records. The coordinator will assist with audit readiness, maintaining protocol-specific SOPs, IRB and regulatory correspondence, and demonstrating awareness of federal regulations, state and local laws, GCP/ICH, and CCHMC policies to promote ethical practices and ensure compliance. Recognizing the importance of reporting concerns to supervisors and seeking out research educational opportunities are key. The position involves maintaining awareness of active studies, identifying eligible participants, coordinating study visits, providing instructions and reimbursement to participants, and approaching potential participants professionally. Conducting pre-consent screening, executing the informed consent process according to GCP and CCHMC procedures, and communicating with participants' clinical teams are essential. Documenting participant interactions and communicating recruitment/retention challenges and recommendations to study leadership are also required. The role includes organizing and filing correspondence, referring questions to appropriate research team members, and maintaining awareness of study-related issues involving various stakeholders. Building rapport with participants and providing input to division discussions related to clinical research studies are important. The coordinator will participate in meetings and activities to improve organizational performance. Data management responsibilities include completing Case Report Forms (CRFs) and source documentation, reviewing CRFs for completeness and accuracy, entering data into databases, maintaining internal record-keeping systems, ensuring accuracy of documentation, performing quality checks, and supporting the data-management process by addressing data queries.

Requirements

High school diploma or equivalent
2+ years of work experience in a related job discipline or equivalent combination of education and experience
May require an Associate degree, vocational training, apprenticeships or equivalent

Responsibilities

Assist in coordinating studies by preparing personnel and materials, preparation of protocols, informed consents, amendments and other necessary documents for review by the IRB and Sponsor.
Assemble lab kits and/or gather supplies.
Collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedure (SOP) or other work instruction set.
Ensure specimens are properly logged, handled and stored.
Follow direction of clinical research coordinator or others involved in the clinical research project work.
Assist other staff members and coordinators to implement studies.
Maintain inventory of supplies and equipment.
Operate standard laboratory and research study equipment, if applicable.
Troubleshoot and correct erroneous results or problems with equipment.
Identify regulatory activities to be completed and takes the initiative to complete.
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 SOP's, IRB and regulatory correspondence.
Demonstrate an awareness of federal regulations; state and local law; GCP/ICH and CCHMC policies to promote ethical practices in research involving human participants and to ensure compliance to those regulations.
Recognize the importance of reporting concerns of ethical and/or regulatory issues to supervisor in a timely manner.
Assist with the documentation of regulatory activities and maintenance of the regulatory binder in keeping with the institution and division SOPs.
Seek out research educational opportunities.
Maintain awareness of 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 form with participant and provide time for participant 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 team 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 the study leadership.
Provide recommendations to improve recruitment and retention to the 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 team, managers and other institutions.
Maintain relationship with participants.
Develop a rapport with study participants.
Provide input to division discussions related to clinical research studies.
Participate in meetings, discussions and activities designed to improve organizational performance through 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 statistician, and sponsors.