Report Writer I
- Employer
- Inotiv
- Location
- Gaithersburg, MD
- Start date
- Nov 23, 2021
View more
- Discipline
- Clinical, Clinical Documentation
- Required Education
- Bachelors Degree
- Position Type
- Full time
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Job Title:
Report Writer I
Qualifications:
BS/BA degree and/or at least 2 years of experience; excellent computer, communication and writing skills; ability to work independently.
Corporate Responsibilities:
- Adherence to laboratory health and safety
- Adherence to Standard Operating Procedures (SOPs)
- Adherence to applicable company policies and guidelines
- Adherence to federal and/or local regulations as applicable
Essential Position Responsibilities:
- Ability to navigate critical reporting software systems (MSWord, Excel, Provantis) and work with scanned document image files.
- Review study protocols and amendments, prepare reporting schedules, and participate in study meetings.
- Monitor critical phases of study and interact with toxicology staff and subcontractors, as needed, for compliance with protocol, SOPs and applicable regulations.
- Perform periodic reviews of study data and prepare data summaries for Study Directors and clients as required.
- Compile data tables and materials/methods for multiple toxicology reports and data packages, concurrently.
- Verify findings and review raw data, consulting the Study Director regarding any abnormalities.
- Address applicable findings from QA audits and coordinate receipt of responses from operational groups.
- Work with Study Director to incorporate client comments into a revised draft.
- Oversee disposition of study specimens, i.e., test article, formulations, blood samples, preserved tissue.
- Finalize study report and coordinate archiving activities.
Additional Position Responsibilities: (if applicable)
- Assist other Report Writers and Study Directors as needed.
- Communicate with clients as needed.
- Perform other duties as assigned.
Additional Requirements:
· Overtime and weekend work as required.
· Work may require the use of PPE (personal protective equipment)
Professional Responsibilities:(if applicable)
· Attend continuing education courses, as appropriate.
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