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Sr Scientist Clinical Research
Company | Medline |
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Location | Northbrook, IL, USA |
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Salary | $115440 – $173160 |
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Type | Full-Time |
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Degrees | Bachelor’s |
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Experience Level | Senior |
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Requirements
- Bachelor’s degree
- 1 year relevant work experience
- Basic level skill in Microsoft Office
- Strong communications skills
- Willing to travel up to 80% of the time domestically or internationally with overnight stays
Responsibilities
- Collaborate with the Clinical Research teams to develop or update study protocol(s) and any related forms, templates, or tools such as the Informed Consent Forms (ICFs), the CRFs (Case Report Forms), Clinical Monitoring Plan, recruitment materials, and any other study related documents for both Internal and External clinical trials.
- Collaborates with other Clinical Research team members on study strategy and budget development (ex: Fair Market Value software).
- With support and supervision, plans, conducts, and executes all types of monitoring visits in compliance with ICH/GCP, FDA Code of Federal Regulations (CFR), or other requirements.
- With support and supervision, completes/documents study visit activity, study records and data management, as well as any required updates or team communications and tracking in any applicable system (eTMF, CTMS, TEAMs, SmartSheet, etc.) in accordance with established processes and guidance.
- Identify, escalate, and support management of risks associated with study related or compliance issues such as protocol, SOP, or ICH/GCP adherence, data integrity, subject protection or delays in issue resolution.
- Performs other related activities as assigned.
Preferred Qualifications
- Preferred in life science (ex. biology, biomedical, nursing, microbiology, psychology)