The Clinical Research Associate works under the direction of investigators to coordinate observational (non-treatment) studies and provides on-going data management for local and national research studies. May assist Clinical Research Coordinators (CRC) with more complex trials. Assists investigators with preparing documents for IRB and sponsor submissions, screening and recruitment, consenting subjects, preparing adverse event and case report forms, maintenance of research databases, sample procurement and shipping.
Essential Duties and Responsibilities
•Through experience, has developed technical knowledge and skills to perform a variety of routine activities
•Understands how own duties relate to others in the team and has an awareness of how the team integrates with others
•Manages own workload by applying an understanding of team priorities; may provide assistance to less experienced colleagues
•Recognizes and solves typical problems that can occur in own work area; evaluates and selects predefined solutions from established operating procedures
•Impacts the performance of own team through the quality of the services or information provided
•Follows standardized procedures and practices and receives regular but moderate supervision and guidance
•Communicates moderately complex technical information in straightforward situations
•Be knowledgeable of multiple protocol requirements and visit schedules. Familiar with medical terminology and competent at reviewing medical records. Understand each study's eligibility requirements and assists clinical staff with completing research related tasks. Assists with screening patient records, recruiting patients and obtaining informed consent. Collect and record research data on case report forms and in databases as applicable. Facilitate scheduling of research visits. Assists with development and maintenance of study specific databases as applicable.
•Assists with obtaining / maintaining regulatory and institutional approval for research studies including but not limited to initial submissions, modifications, annual reviews and adverse events reporting, creating forms (consent forms, HIPAA forms, project summaries, etc) and new research questionnaires for UT Institutional Review Board and Children's Medical Center Research Department. Consults with Children's Medical Center Research Department to facilitate study budgets if indicated. Ongoing oversight of research billing to ensure appropriate research account is charged.
•Coordinate sample procurement according to protocol. Maintain samples of fluids and / or tissue in a sterile condition and promptly distribute to local and national clinical and research laboratories. May assist in labeling and storing of blood, urine and other specimens for analysis. Package and ship samples according to local and federal IATA guidelines. Reconcile shipment billing.
•Requires occasional attendance at out of town professional meetings.
•Performs other position appropriate duties as required in a competent, professional and courteous manner.
•Four-year Bachelor's degree in Health-related Sciences field, preferred
Licenses & Certifications
•Minimum 1 year of related experience, preferred
•Clinical research and / or pediatric clinical experience, preferred
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.
•Ensure that the customer perspective is a driving force behind business decisions and activities; craft and implement service practices that meet customers' and own organization's needs.
•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.
•Effectively manage one's time and resources to ensure that work is completed efficiently.
•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.
•Set high standards of performance for self and others; assume responsibility and accountability for successfully completing assignments or tasks; self impose standards of excellence rather than having standards imposed.
•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
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