Clinovo
Senior Regional Clinical Research Associate
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Position Description:
We are seeking a Regional Clinical Research Associate (CRA) Consultant to provide monitoring support for an ongoing global oncology clinical trial. This individual will serve as a fractional extension of the Clinical Operations team, supporting clinical trial sites across the United Kingdom and Italy, with the potential to support additional sites in Spain as the study expands.
Working alongside an existing regional CRA, this consultant will conduct routine monitoring visits, assist with site activation activities, and ensure sites remain compliant with protocol requirements, Good Clinical Practice (GCP), and applicable regulatory standards. The engagement is expected to begin with approximately 1–2 monitoring visits per month, with the potential for increased activity as additional sites are initiated.
This is an excellent opportunity for an experienced freelance or independent CRA seeking a flexible, long-term consulting engagement. Candidates must be home-based in the UK for this opportunity.
Responsibilities:
- Perform site qualification, site initiation, routine monitoring, site management, and close-out visits (onsite and remote as required).
- Monitor assigned investigative sites to ensure compliance with study protocols, ICH GCP guidelines, applicable regulations, and company SOPs.
- Serve as a primary point of contact for assigned clinical sites and maintain effective site relationships.
- Assess overall site performance and identify opportunities to improve study execution and protocol compliance.
- Identify and escalate issues impacting subject safety, protocol compliance, or data integrity, while collaborating on appropriate corrective actions.
- Verify informed consent documentation and ensure consent processes have been appropriately conducted.
- Perform Source Data Review (SDR) and Source Data Verification (SDV) in accordance with the Monitoring Plan.
- Review investigational product accountability, storage, and reconciliation procedures.
- Maintain oversight of Investigator Site Files (ISF) to ensure documentation is complete and inspection-ready.
- Prepare monitoring visit reports and ensure timely follow-up of action items.
- Contribute site metrics and monitoring updates to project tracking systems.
- Support site activation activities and collaborate with cross-functional teams to meet study timelines.
- Participate in investigator meetings and other study-related meetings as required.
- Assist sites in maintaining audit and inspection readiness throughout the duration of the study.
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Required Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or another scientific or healthcare-related discipline.
- Minimum of two years of Clinical Research Associate (CRA) or Clinical Monitor experience within a biotechnology company, pharmaceutical company, or CRO.
- Previous experience monitoring oncology clinical trials strongly preferred.
- Strong working knowledge of ICH GCP, FDA/EMA regulations, and global clinical trial monitoring practices.
- Experience performing site qualification, initiation, monitoring, and close-out visits.
- Excellent organizational, communication, and problem-solving skills.
- Ability to manage multiple investigative sites independently in a fast-paced clinical development environment.
- Proficiency with Microsoft Office applications.
- Experience working with clinical systems such as EDC, CTMS, IRT, and TMF platforms is preferred.
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Preferred Qualifications:
- Prior experience supporting multinational clinical trials across Europe.
- Experience working in small or emerging biotechnology environments.
- Experience supporting early-phase oncology studies.
- Previous consulting or freelance experience preferred.
Language Requirements:
- Fluent English required.
- Italian fluency strongly preferred.
- Spanish language skills are considered an asset.
Travel:
Up to 75% travel within the assigned region.
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