The Clinical Research Associate works under the direction of investigator(s) 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 investigator(s) 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
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. Faciliate 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.
Four-year Bachelor's degree or equivalent experience preferred
Licenses & Certifications
Clinical research and/or pediatric clinical experience preferred
Specific knowledge, skills, and abilities
Knowledge of the Belmont report and Code of Federal Regulations
Intermediate to advanced computer skills including a variety of software applications (e.g. spreadsheet and database programs, interactive web based software).
Effective, organizational skills and attention to detail; effective follow-through, and commitment to excellence.
Effective professional communication skills: Ability to communicate with others in a clear, understandable, and professional manner.
Physical and emotional health adequate for attendance requirements and performance, which may include, but is not limited to: assessment of patient conditions, appropriate use of technical equipment, and rapid recognition and response to emergency situations.
Maintain compliance with standards for clinical personnel established by Children's.
Maintain skills and certifications required by the Research Department.
Appearance projects a professional image and engenders the confidence of others.
Light - Exerting up to 20 lbs. occasionally, 10 lbs. frequently, or negligible amounts constantly and may require walking or standing to a significant degree.