Site Visits Report Reviewer (India)
About The Position
The Site Visit Report Reviewer (SVRR) is responsible for the review and approval of site visit reports within the timebound metrics agreed with the specific Sponsor being reviewed for or SOP agreed.
Within this review and approval come the surveillance of both the site and study level performance and quality issues as well as documentation/escalation of the same.
This role will be perfect for you if:
- You enjoy working with a Canadian-owned mid-sized CRO where you can build professional relationships with your colleagues at all levels
- You bring previous experience in reviewing CRA reports
- Dermatology is a therapeutic area you enjoy or want to learn more about
More specifically, the Site Visit Report Reviewer will:
- Review and approve site visit reports, including the verification that issues and action items are appropriately documented and addressed in a timely manner and no later than 60 days after the issue was identified.
- Confirm monitoring is being completed as per CMP and that applicable supporting documentation requirements are being adhered to, i.e., PD Specification Documentation)
- Follow-up with Clinical Research Associates (CRAs) to ensure compliance with draft and finalization timelines for site visit reports and follow-up letters.
- Track site visit report and follow-up letter metrics.
- Maintain an issue escalation log based on observations from the site visit reports and escalate issues to project teams.
- Discuss with project team the trends observed across site visit reports, CRA performance concerns related to site visit completion and issue resolution, and opportunities to improve site visit report completion guidelines.
- Minimum Bachelor’s degree
- Minimum 3 years’ experience in the biotechnology, pharmaceutical, and/or CRO industry.
- Previous monitoring experience as a CRA and/or in reviewing site visit reports is an asset.
Knowledge and skills
- Solid knowledge of clinical trial operations, ICH /GCP Guidelines and other applicable regulatory requirements.
- Fluent in English (oral and written)
- Computer skills including proficiency in the use of CTMS, Microsoft Word, Excel, PowerPoint.
- Attention to detail and accuracy in work.
- Strong organizational, communication, problem-solving, and experience time coding to studies in a mindful fashion.
At Innovaderm, you will work with brilliant and driven professionals. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
As a Site Visits Report Reviewer, you will be eligible for the following conditions:
- Flexible work schedule
Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Canada, Innovaderm continues to grow and expand in North America and Europe.