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.
Responsibiliti
- esPerform 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 SOP
- s.Serve as a primary point of contact for assigned clinical sites and maintain effective site relationship
- s.Assess overall site performance and identify opportunities to improve study execution and protocol complianc
- e.Identify and escalate issues impacting subject safety, protocol compliance, or data integrity, while collaborating on appropriate corrective action
- s.Verify informed consent documentation and ensure consent processes have been appropriately conducte
- d.Perform Source Data Review (SDR) and Source Data Verification (SDV) in accordance with the Monitoring Pla
- n.Review investigational product accountability, storage, and reconciliation procedure
- s.Maintain oversight of Investigator Site Files (ISF) to ensure documentation is complete and inspection-read
- y.Prepare monitoring visit reports and ensure timely follow-up of action item
- s.Contribute site metrics and monitoring updates to project tracking system
- s.Support site activation activities and collaborate with cross-functional teams to meet study timeline
- s.Participate in investigator meetings and other study-related meetings as require
- d.Assist sites in maintaining audit and inspection readiness throughout the duration of the stud
y.Required Qualificatio
- nsBachelor's degree in Life Sciences, Nursing, Pharmacy, or another scientific or healthcare-related disciplin
- e.Minimum of two years of Clinical Research Associate (CRA) or Clinical Monitor experience within a biotechnology company, pharmaceutical company, or CR
- O.Previous experience monitoring oncology clinical trials strongly preferre
- d.Strong working knowledge of ICH GCP, FDA/EMA regulations, and global clinical trial monitoring practice
- s.Experience performing site qualification, initiation, monitoring, and close-out visit
- s.Excellent organizational, communication, and problem-solving skill
- s.Ability to manage multiple investigative sites independently in a fast-paced clinical development environmen
- t.Proficiency with Microsoft Office application
- s.Experience working with clinical systems such as EDC, CTMS, IRT, and TMF platforms is preferre
d.Preferred Qualificatio
- nsPrior experience supporting multinational clinical trials across Europ
- e.Experience working in small or emerging biotechnology environment
- s.Experience supporting early-phase oncology studie
- s.Previous consulting or freelance experience preferre
d.Language Requiremen
- tsFluent English require
- d.Italian fluency strongly preferre
- d.Spanish language skills are considered an asse
t.Trav
- elUp to 75% travel within the assigned regio
n.
