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Form of workJOB SUMMARY
Conduct and manage human clinical trials and other research related activities with direction from other Clinical Operations management or designee and in accordance with ICH International Committee for Harmonization and Good Clinical Practices (ICH/GCP) guidelines, and Medline Industries, LP. Standard Operating Procedures (SOPs).
MAJOR RESPONSIBILITIES
- Collaborate with the Medical Affairs (MA) 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 Medical Affairs 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.
Education
- Bachelor's degree. Preferred in life science (ex. biology, biomedical, nursing, microbiology, psychology).
Certification / Licensure
- None required.
Work Experience
- 1 years relevant work experience.
Knowledge / Skills / Abilities
- Basic level skill in Microsoft Office.
- Willing to travel up to 80% of the time domestically or international with overnight stays.
- Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates.
- Strong communications skills.
COVID-19 Vaccination
Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law.
