Clinical Research Associate I - Heart Institute - Makkar Lab
About The Position
The Clinical Research Associate I supports the coordination and implementation of noncomplex research studies at the Smidt Heart Institute, working under the supervision of Principal Investigator and Research Scientist Dr. Raj Makkar and under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff. The role supports research objectives through data collection, participant evaluation and scheduling, IRB assistance, budget management, and regulatory compliance. The position evaluates and abstracts clinical research data, completes and enters case report forms and other study data, assists with regulatory submissions and trial budgets, and supports participant prescreening and research visits. Patient contact is supervised or limited to long-term follow-up patients. The role also handles research samples and supplies while maintaining compliance with applicable regulations, Good Clinical Practice, and patient confidentiality requirements.
Requirements
- High School Diploma or GED.
- One year of clinical research-related experience is preferred.
Nice To Haves
- Bachelor's degree in Science, Sociology, or a related field.
- One year of clinical research-related experience.
Responsibilities
- Coordinate and implement studies in collaboration with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse.
- Evaluate and abstract clinical research data from source documents.
- Ensure compliance with study protocols and overall clinical research objectives.
- Complete Case Report Forms (CRFs).
- Enter clinical research data into sponsor-provided Electronic Data Systems (EDCs).
- Provide supervised patient contact or patient contact for long-term follow-up patients only.
- Assist with Institutional Review Board (IRB) submissions, including Adverse Events, Serious Adverse Events, and Safety Letters, in accordance with local and federal guidelines.
- Assist with clinical trial budgets.
- Assist with patient research billing.
- Assist with prescreening potential research participants for clinical trials.
- Schedule patients for research visits and procedures.
- Prepare and ship samples, and maintain study supplies and kits.
- Ensure compliance with federal and local agencies, including the Food and Drug Administration (FDA) and local IRB.
- Maintain research practices using Good Clinical Practice (GCP) guidelines.
- Maintain patient confidentiality in accordance with HIPAA regulations and applicable law.
- Participate in required training and education programs.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
