Job Board

Description

Clinical Research Coordinator III or IV - Hospital Medicine

SUBFUNCTION DEFINITION: The Division of Hospital Medicine is a passionate group of clinicians, researchers, quality improvement experts, and staff who are dedicated to improving the lives of hospitalized children and their families. Our studies focus on topics such as: improving transitions of care from the hospital to home, providing food to hospitalized families who are hungry, reducing monitor overuse, and identifying families in need and connecting them to resources. We are seeking to hire and train the right candidate who is interested in helping patients and families while learning research and quality improvement skills.

The Division of Hospital Medicine is seeking a CRC III or IV to join our team to work on a recently funded Patient Centered Outcomes Research Institute (PCORI) study that seeks to evaluate the impact of pre- and post-discharge telehealth huddles on patient and family outcomes.

In addition to traditional CRC duties such as: patient recruitment and retention, data extraction from the electronic health record system (Epic), and creating and managing REDCap databases, this role will set meeting agendas and lead study team meetings, assist the principal investigators (PIs) with the review of recruitment, retention, and intervention completion rates, and work with fellow CRCs to improve these rates if necessary.

CCHMC SALARY GRADE: 7

REPRESENTATIVE RESPONSIBILITIES

• Study Conduct/Clinical Research Practice

Assist in coordinating studies by preparing personnel and materials, preparation of protocols, informed consent documents, data collection forms and other necessary documents for review by the Institutional Review Board (IRB). Assist other staff members and coordinators to implement studies and maintain inventory of supplies and equipment. Maintain awareness of status of all active studies. Serve as a resource for other clinical research professionals in all aspects of conducting a clinical trial or quality improvement project. Collaborate with investigator(s) and coworkers to ensure proper progress and completion of clinical studies or study tasks. Train new staff in preparation and conduct of clinical trials or quality improvement projects. Arrange for facilities and supplies when applicable. Ensure participant and study compliance. Maintain all records and files required by regulatory agencies and sponsors. Rarely, the CRC may help with biospecimen collection, including but not limited to assemble lab kits and/or gather supplies, collect, label, and/or process samples as instructed and deliver or process samples in accordance with the protocol.

• Regulatory Compliance and Documentation

Identify regulatory activities to be completed and take the initiative to complete. Prepare, submit & maintain all regulatory submissions (proposed new studies, annual review, amendments, & adverse events) accurately and within a timely manner to all collaborative parties. Periodically self-audit records to ensure audit-readiness. Prepare, plan, and participate in all monitor visits, audits, and quality reviews (internal and external) in a professional manner. Oversee the review, correspondence and 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, and coordinate the process to meet these requirements). Apply legal, regulatory and policy parameters to promote ethical practices in research involving human participants and to ensure compliance to those regulations. Document the conduct of each protocol's regulatory activities in appropriate systems. Maintain up-to-date and accurate written and electronic records and 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 and follow through on issues. Demonstrate an awareness of federal regulations, state and local law, Good Clinical Practices (GCP)/ International Council for Harmonisation (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. Seek out research educational opportunities.

• Recruitment/Enrollment/Retention

Determine best methods 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 and screen potentially eligible participants, most often hospitalized pediatric patients and/or their families, but may also include other care providers. Coordinate, plan and execute study activities (e.g., surveys, interviews, observations, focus groups) and provide instructions and reimbursement to participants. Approach potential participants and families in a professional manner. When applicable, facilitate the informed consent process according to GCP, CCHMC procedures and other applicable policies. 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. Maintain awareness of the status of all active studies. Communicate with participants' clinical team regarding study participation. Proactively identify and monitor barriers to recruitment and problem solve or innovate to overcome them.

• 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 participants, investigators, study coordinators, clinical team, managers and other institutions. Build relationships with participants and maintain ongoing rapport to foster engagement in the research. Provide input to division 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. Assist with facilitating study team meetings by contributing to agendas, taking notes, and following up on next steps.

• Data Management

Create case report forms (CRFs) in consultation with other team members, as needed, using existing study data information to promote efficient data collection and data entry. Complete 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

EDUCATION/EXPERIENCE

Required for CRC III:

• Master's degree; OR
• Bachelor's degree AND at least 1 year of experience in clinical research work; OR
• Other equivalent combination of education and experience

Required for CRC IV:

• Certification as a Clinical Research Coordinator (SOCRA) AND
• Master's Degree and 2 years' related experience in clinical research; OR
• Bachelor's Degree and 3 years of experience in clinical research work; OR
• Other equivalent combination of education and experience