Clinical Research Coordinator II or III

3 months ago

Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time
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.


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. This position does require in-person work in Cincinnati conducting study visits. Applicants of diverse and underrepresented backgrounds are especially encouraged to apply. The ideal candidate will be a fluent Spanish-speaker and interested in the opportunity to become Qualified Bilingual certified through Cincinnati Children’s in order to use their language skills in recruitment and study procedures.

This CRC role will focus on studies with foci that include:
• Food access, eating behavior, and cardiometabolic health in adolescents
• Mixed methods, such as use of daily diary surveys and qualitative interviews
• Engaging Hispanic/Latino and Spanish-speaking families in the Cincinnati community
• Disordered eating and weight-related health in the context of social determinants of health
• Preventive interventions for eating behavior in pediatrics

Tasks in the CRC role may include but are not limited to:
• Conducting Academic literature searches
• Reference formatting and management
• Preparing manuscripts for submission to journals
• Data entry and data management using SPSS
• Participating in preparing materials for review by the IRB
• Recruitment and data collection at both community and clinical sites
• Participating in meetings with community partners.
• Participating in the preparation of conference presentations

Qualifications

Required qualifications for the CRC role are:
• Having completed a Bachelor’s degree or Masters degree in psychology or related field
• Experience with psychosocial and/or health-related research and working as part of a research team

Preferred experience:
• Experience working with adolescents in clinical or research capacities
• Experience with RedCap and statistical software such as SPSS

Necessary skills and strengths:
• Bilingual (Spanish)
• Communication
• Orientation to detail
• Problem-solving

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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/AA/M/F/Veteran/Disability

Job

Professional/Non-Clinical

Shift

Day Job

Job Type

Standard
Department
BMCP

Employee Status

Regular
FTE
1.0
Weekly Hours
40

Salary Range

21.21-28.30

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