Contract Clinical Oversight Monitor
4 weeks ago
The Senior Clinical Oversight Monitor (Sr. COM) is a remote field based role, responsible for providing support to the clinical research sites as their primary contact for the study, conducting qualification visits and site initiation visits on behalf of the sponsor and conducting sponsor quality oversight assessment visits to assess the performance of the CRO CRA.
Essential Responsibilities:
- Primary sponsor contact for clinical sites to answer operational and protocol questions.
- Perform telephone and/or on site qualification visits and onsite initiation visits as the sponsor representative in accordance with SOP.
- Oversees monitoring activities conducted by the CRO are performed with quality in compliance with clinical monitoring plan and in accordance with SOPs, GCP and all applicable laws and regulations.
- Conduct onsite sponsor quality oversight assessment visits to clinical sites to assess performance of the CRO CRA and onsite clinical site visits to provide additional support to sites as required (i.e., attending first dosing day).
- Provides input to the clinical development plan and operational aspects of the clinical trial protocol (e.g., develops and/or reviews operational plans for trials).
- Identifies and/or anticipates operational risks and mitigation plans within assigned clinical trials and escalates issues and recommends contingency plans to Director of Clinical Operations as necessary.
- Provide monitoring oversight including authoring of oversight plan, reviewing monitoring visit reports and perform periodic oversight visits to sites and/or vendors to assess progress and compliance.
- Serves as functional area reviewer of global clinical / regulatory submissions.
- Requires a BS or equivalent in the health or life sciences.
- A minimum of 5 years of LEAD CRA/Monitoring (on site) clinical research experience at a Biotech/Pharmaceutical company
- Ability to travel within the US and Canada is required (role assumes 60% travel).
- Co-monitoring or CRA line management responsibilities is preferred.
- Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required.
- Excellent communication skills, ability to build strong relationships with peers and cross functional team members and CRO/Vendor partners, experience mentoring clinical study staff and presenting to senior management is required.
- Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook; Electronic Data Capture Systems).
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