The Clinical Research Coordinator may coordinate device and drug treatment research trials as well as observational studies conducted at Children's Medical Center, including but not limited to study set-up, implementation, fiscal monitoring, and data collection/entry. Usually serves as the Children's employee managing the coordination of all aspects of the assigned research project(s) at Children's in support of the Principal Investigator and ensuring compliance with all Children's policies, state and federal regulations that govern clinical research. **Please note, this is a foundation funded position**
Job Specific Responsibilities:
Evaluate patients for inclusion and exclusion criteria on multiple protocols. Consent and enroll subjects on trials as appropriate. Be familiar with treatment and visit schedules for assigned studies. Coordinate/perform scheduling of procedures and treatments and serve as an educational resource for participants regarding study requirements. Be proficient at reviewing medical records to assess patient's disease status, treatment course, and adverse events. Complete case report forms and submit to sponsor according to deadlines. Participate in long-term follow-up efforts on research participants and submit on-going data. Communicate with pharmacy to ensure investigational drug is ordered per protocol when needed. Clinically licensed coordinators may be responsible for administering study related medications.
Open and maintain institutional approval for research studies including but not limited to initial UT Institutional Review Board submissions (creating consent forms, HIPAA forms, project summaries), new research questionnaires for IRB and Children's Medical Center Research Department, amendments, annual reviews and adverse event reporting. Consult with Children's Medical Center Research Department to establish budgets and ongoing oversight of research billing to ensure compliance with laws regarding research billing. Communicate with sponsor to keep all documents updated. Communicate with physicians and clinical staff regarding patient research participation.
Coordinate sample procurement according to protocol and disease. Maintain samples of fluids and/or tissue in a sterile condition and promptly distribute to local and national clinical and research laboratories. Assist in labeling and storing of blood, urine and other specimens for analysis. Collect, correlate and file patient records and laboratory data for analysis. Receive reports and facilitate Principal Investigator review of results. Package and ship samples according to local and federal IATA guidelines. Reconcile shipment billing.
Required: Minimum 1 year of related experience
Preferred: Four-year Bachelor's degree or equivalent experience
Preferred: Graduate or professional work or advanced degree; or equivalent experience
Specific Knowledge, Skills and Abilities:
Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjust effectively to work within new work structures, processes, requirements, or cultures. Use appropriate interpersonal styles to establish effective relationships with customers and internal partners; interact with others in a way that promotes openness and trust and gives them confidence in one's intentions. Meet patient and patient family needs; take responsibility for a patient's safety, satisfaction, and clinical outcomes; use appropriate interpersonal techniques to resolve difficult patient situations and regain patient confidence. Develop and use collaborative relationships to facilitate the accomplishment of work goals. Identify and understand issues, problems, and opportunities; compare data from different sources to draw conclusions; use effective approaches for choosing a course of action or developing appropriate solutions; take action that is consistent with available facts, constraints, and probable consequences. Take prompt action to accomplish objectives; take action to achieve goals beyond what is required; be proactive. Deal effectively with others in an antagonistic situation; use appropriate interpersonal styles and methods to reduce tension or conflict between two or more people. Accomplish tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time. Assimilate and apply new job-related information in a timely manner. Clearly convey information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.
Licenses and Certifications:
Preferred: CCRP/CCRC certification through SoCRA / ACRP
Light - Exerting up to 20 lbs. occasionally, 10 lbs. frequently, or negligible amounts constantly and may require walking or standing to a significant degree.
is such a privilege. It is one of the top pediatric hospitals in the country. The opportunities available to you for education and career advancement are virtually limitless. Once people in the community find out where you work, they are eager to share their Children’s Health experiences and the impact it had on their lives.
Amy, RN, BSN, AE-C
Clinical Research Coordinator