Site Visits Report Reviewer, India

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.

Requirements:

IDEAL PROFILE

Education

• Minimum Bachelor's degree

Experience

• 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.

Our company:

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Flexible work schedule
• Permanent full-time position
• Ongoing learning and development

Work location

Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.

About Indero

A Global Clinical Leader In Dermatology

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years' experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in India.

Brand name:

Indero