Clinical Research Associate I, Per Diem -Surgery Chair
About The Position
The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to support the coordination and implementation of noncomplex research studies. The role supports study objectives through tasks including data collection, prescreening and scheduling research participants, assisting with IRB submissions, supporting budgets and billing, and maintaining compliance with applicable guidelines. The associate may collect, evaluate, and abstract clinical research data; help design data collection forms; enter and process data in sponsor-provided electronic data systems; and complete Case Report Forms. The role also supports participant scheduling and research visits, regulatory submissions, sample preparation and shipping, study supply maintenance, and communications with external sponsors for select trials. Patient contact is supervised, except for independent contact with long-term follow-up patients. The position helps ensure compliance with study protocols, federal and local requirements, FDA and IRB requirements, Good Clinical Practice guidelines, and HIPAA and other applicable confidentiality laws.
Requirements
- High school diploma or GED.
- Maintain patient confidentiality according to HIPAA regulations and applicable law.
- Follow Good Clinical Practice guidelines and applicable federal and local research requirements.
Nice To Haves
- Bachelor's degree in science, sociology, or a related field.
- One year of clinical research-related experience.
Responsibilities
- Collect, evaluate, and/or abstract clinical research data; assist with designing data collection or abstraction forms.
- Enter and process clinical research data in sponsor-provided Electronic Data Systems and complete Case Report Forms.
- Assist with prescreening potential research participants and schedule participants for research visits and procedures.
- Provide supervised patient contact, or independent contact for long-term follow-up patients only.
- Assist supervising staff with Institutional Review Board submissions, including submissions of Adverse Events, Serious Adverse Events, and Safety Letters, in accordance with local and federal guidelines.
- Assist with clinical trial budgets and patient research billing.
- Prepare and ship samples and maintain study supplies and kits.
- Ensure compliance with study protocols, research objectives, applicable federal and local agency requirements, Good Clinical Practice guidelines, and HIPAA and other applicable confidentiality requirements.
- Serve as a point of contact for external sponsors on select trials, respond to sponsor inquiries, and attend study activity meetings under supervising staff direction.
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What This Job Offers
Career Level
Entry Level
Education Level
High school or GED
