As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
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.
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)
• 3-5 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.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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