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Vanderbilt Univ Medical Center - Nashville, TN
posted 2 months ago
About the position
The position is responsible for coordinating the approval processes and conduct of research protocols within the Neuro-Immunology Division at Vanderbilt University Medical Center. The role ensures the integrity and quality of clinical/translational research while adhering to institutional policies and federal regulations. The individual will assist in preparing IRB research proposals, maintaining documentation, procuring necessary supplies, and ensuring compliance with research protocols.
Responsibilities
- Prepares and processes new IRB research proposals, amendments, continuing review applications, and adverse event reports according to institutional and departmental policies and federal regulations.
- Maintains documents required for regulatory authorities and sponsors during and after clinical/translational trials.
- Procures equipment and supplies needed for project requirements.
- Records data from source documentation onto case report forms with attention to accuracy and completeness.
- Packages and ships study specimens to sponsors or laboratories in accordance with guidelines and regulations.
- Assists with study completion, closeout, and archiving of study files, ensuring continuity of study data.
- Develops and manages study budgets, monitoring invoicing and maintaining clinical trial billing compliance.
- Establishes and maintains communication with investigators, research staff, sponsors, and participants to advocate for human subjects.
- Determines eligible candidates for study participation and assesses potential participants' medical and historical information.
- Performs or instructs others in research procedures as described in the protocol, reporting any deviations timely.
Requirements
- Bachelor's degree required.
- Less than 1 year of relevant work experience.
- Fundamental awareness of project coordination, study design, communication, and clinical research.
Nice-to-haves
- Experience in clinical research settings.
- Familiarity with IRB processes and regulatory compliance.
Benefits
- Health insurance coverage.
- Dental insurance coverage.
- 401k retirement savings plan.
- Paid holidays and vacation time.
