(Senior) Centralized Study Associate

We are building a Centralized Delivery Hub in Bulgaria and are recruiting for several experienced Study Specialists to join our team!

Responsibilities will include:

• Follow all applicable departmental Standard Operating Procedures and Work Instructions.
• Complete day-to-day tasks ensuring quality and productivity.
• Track and report metrics as determined by management according to required timelines.
• Participate in process improvement opportunities and assist with the implementation of revised processes and procedures.
• Other duties/activities as assigned by study management team, but not limited to:
• Manage clinical systems & access management
• Manage study documents and support eTMF management
• Maintain study databases (CTMS, IWRS, EDC etc.)
• Support study team in data review and support activities.
• Track and follow up with CRAs for outstanding issues
• Support in generating the study specific reports.
• Manage internal/external communications
• Assist in ensuring training compliance for study teams
• Manage study payments (Site and Vendor)
• Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support.
• Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive, as applicable.
• Actively support compliance metrics including TMF, CTMS, and overall project health.
• Update timelines and milestones within project scheduling tools, CTMS, project governance tool, and other trackers which will include updates for all applicable functions. Escalate when timelines are a risk.
• Update Xcellerate Risk Identification & Issue Resolution (XRIM) tool and follow up outstanding action items to resolution including Protocol Deviations.
• Draft or assist Functional Leads with project plans and coordinating review, feedback, and execution between study team and client.
• Work with Study Team to maintain WISER moments.
• May assist with additional cross-functional tasks according to project needs.
• Additional responsibilities (Centralized study team may perform below activities):
• Facilitate study team communication & collaboration by attending & setting up team meetings for all functions, as needed.
• Facilitate and document meetings with relevant tools in internal and external calls and ensure they are distributed and documented in accordance with study requirements.
• Vendor Management oversight.

Qualifications • University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex: Nursing certification, Medical or laboratory technology) • 1-2 years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations. • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.