Description

SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical trials conducted within the assigned department.

CLINICAL RESEARCH COORDINATOR II
REPRESENTATIVE RESPONSIBILITIES

???Study Conduct/ Clinical Research Practice
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.

???Regulatory Compliance and Documentation
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.

???Recruitment/Enrollment/Retention
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.

???Communication
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.

???Data Management
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.

SUBFUNCTION DEFINITION: The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical trials conducted within the assigned department.

CLINICAL RESEARCH COORDINATOR III
REPRESENTATIVE RESPONSIBILITIES

???Study Conduct/ Clinical Research Practice
Maintain awareness of status of all active studies. Arrange for facilities and supplies. Ensure participant and study compliance, i.e. collection of study specimens, and study visits. Work with study team as needed to define specimen collection, processing and storage procedures. Train others as needed to collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedures (SOP) or other work instruction set. Ensure specimens are properly logged, handled and stored.

Maintain all records and files required by regulatory agencies and sponsors. Serve as a resource for other clinical research professionals in all aspects of conducting a clinical trial. Collaborate with investigator(s) and coworkers to ensure proper progress and completion of clinical studies. Train new staff in preparation and conduct of clinical trials.

???Regulatory Compliance and Documentation
Prepare, submit & maintain all regulatory submissions (proposed new studies, annual review, amendments, & adverse events) accurately & within a timely manner to all collaborative parties. Periodically self-audit records to ensure audit-readiness.

Prepare, plan, & participate in all monitor visits, audits, & quality reviews (internal & external) in a professional manner. Oversee the review, correspondence & approval of human research protocols with all regulatory authorities, including study closeout. Determine which research protocols or issues have additional requirements, e.g. the need for review by additional divisions, regulatory agencies, or consultants, & coordinate the process to meet these requirements.

Apply legal, regulatory & policy parameters to promote ethical practices in research involving human participants & to ensure compliance to those regulations. Document the conduct of each protocol's regulatory activities in appropriate systems. Maintain up-to-date & accurate written & electronic records & files to support clinical research activities.

Continuously update knowledge of regulatory requirements. May act on behalf of the PI in communicating with sponsor, other divisions or institutions to coordinate studies & follow through on issues.

???Recruitment/Enrollment/Retention
Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly. Create and maintain a detailed tracking system for participants considered for enrollment.

Track progress at regular intervals and report out to PI and or management. Identify potentially eligible participants. Conduct pre-consent screening to determine eligibility. Review consent form with participant and provide time for participant to consider study participation. Execute the informed consent process according to GCP and CCHMC procedures and other applicable rules, regulations and policies.

Communicate with participants' clinical team regarding study participation. 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. Make recommendations to improve recruitment and retention to the study leadership.

Engage study staff to assist in identifying and enrolling participants. Proactively identify and monitor barriers to recruitment and problem solve or innovate to overcome them.

???Communication
Compose, document, organize, and maintain all correspondence. Oversee and follow through on questions and issues that arise during study conduct. Serve as CCHMC liaison to internal departments, clinical teams, regulatory agencies, physician's offices, city clinics, government agencies, academic centers, and other organizations.

Communicate study related issues to investigators, sponsors, coordinating centers, study coordinators, clinical and research teams, managers and other institutions. Develop a rapport with study participants.

???Data Management
Create CRFs in consultation with other team members, as needed, using existing study data information to promote efficient data collection and data entry. 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. Review documentation from sources to ensure accuracy.

Enter data into various auditable databases or electronic data-capture systems and/or oversee data entry and validation to ensure accuracy, completeness of data collection process.

Perform data cleaning procedures and quality checks to ensure accuracy of data. Support the data-management process for clinical research projects, including addressing data queries from data managers, project statistician, and sponsors. Review reports, tables, and listings. Assist in data analysis and maintain record keeping and data storage for clinical research studies.

Maintain master database files for clinical research protocols. Prepare reports from validation studies of clinical research projects.

Qualifications

Qualifications - External

EDUCATION/EXPERIENCE

Required for Clinical Research Coordinator II

??? 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

Required for Clinical Research Coordinator III

???Bachelor's degree in a related field and 1 year of directly related experience OR Master's degree in a related field