Clinical Research Coordinator III Hospital Medicine - Cincinnati, United States - cchmc

Description

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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 - 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 also launching new studies focused on optimizing the use of medications in children with medical complexity and pharmacogenetic testing, for which this role is being created.

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.

REPRESENTATIVE RESPONSIBILITIES

• Recruitment, Enrollment and Retention

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 Good Clinical Practices (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.

• Study Conduct/Clinical Research Practice

Assist in coordinating studies by preparing personnel and materials, preparation of protocols, informed consents, 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.

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.
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 standard operating procedures (SOPs), 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.

• 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

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 GCP.
Enter data into various auditable databases or electronic data-capture systems.
Maintain internal record keeping system(s) in conjunction with study team members.
Perform quality checks to ensure accuracy of data.
Create data summaries and reports to track participant enrollment or other data queries.
Support the data management process for projects, including addressing data queries from study team, data managers or statisticians.
Qualifications:

Required for CRC III:

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

Ideal for Specific Role:

• Familiarity and/or experience in the field of pharmacology, pharmacy and/or pharmaceutical sciences
• Familiarity and/or experience with the design and/or execution of clinical trials
• Familiarity with the use of electronic health records and best practice advisories/clinical decision support tools

Cincinnati Children's is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are committed to creating an environment of dignity and respect for all our employees, patients, and families (EEO/AA).
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