As a Clinical Research Associate I, you will work directly with Dr. Michael Lewis and his Clinical Research Coordinator, Research Program Administrator,
Research Nurse, or Principal Investigator to coordinate and/or implement the study.
This role evaluates and abstracts research data and ensures compliance with protocol and research objectives.
Position is responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB.
Provides limited contact with research participants as needed for study and assists with study budget and
research participant billing.
This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Essential job duties and responsibilities:
- Works with a Clinical Research Coordinator, Research Program Administrator, Research Nurse or Principal Investigator to coordinate/implement study.
- Evaluates and abstracts clinical research data from source documents.
- Ensures compliance with protocol and overall clinical research objectives.
- Completes Case Report Forms (CRFs).
- Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
- Provides supervised
contact with research participants or
contact for long term follow-up research participants
- Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
- Assists with clinical trial budgets.
- Assists with patient research billing.
- Schedules patients for research visits and research procedures.
- Responsible for sample preparation and shipping and maintenance of study supplies and kits.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
- BA/BS degree, or equivalent combination of education & experience.
- Understanding of general clinical research objectives.
- Clinical research experience, preferred.
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