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The Clinical Research Data Specialist II manages the data for assigned research studies. This will include, designing forms for data collection, clinical data abstraction, processing data, maintaining record systems, and producing project reports for studies.
This position ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Jobs-Indeed
This position is hybrid*
Primary Duties and Responsibilities :
- May work with bioinformatics in the development and maintenance of clinical trials management systems including validation of systems.
- May train clinical research staff to help improve the quality of the data being collected.
- May solve operational / data problems in consultation with other employees and / or supervisors.
- May perform basic statistical analysis in conjunction with a biostatistician.
- Manages data for research studies.
- Performs clinical data collection / abstraction.
- Processes clinical data using a range of computer applications and database systems to support cleaning and management of subject or patient data.
- Produces project reports.
- Maintains the accuracy, integrity and security of complex, large computerized records systems.
- Understands regulations, policies, protocols and procedures to control and maintain accurate records.
- Performs data searches and other related administrative tasks.
- 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.
Department-Specific Responsibilities :
- Will support PI and research team with analyzing data, results, and assisting with generation of reports.
- Assists with adapting and development of Liver research clinical protocols and leading projects.
- Assists PI with editing and data analysis contributing to development of manuscripts and grant applications.
Required Qualifications :
- Bachelor's degree (BA or BS) is required.
- 2 years of related experience in a similar position is required.
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