As a leading contract research organization (CRO), Labcorp Drug Development (formerly known as Covance) provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
Here at Labcorp Drug Development we are currently recruiting for a Centralized Trip Report Reviewer
, based in Bulgaria
Responsibilities will include :
- Management of projects under direction of a Project Manager / Director as assigned
- Ensure site monitoring responsibility for clinical studies are conducted according to Labcorp Drug Development Standard Operating Procedures, ICH Guidelines and GCP
- Work Closely with project teams in implementation of best TRR practices & applicable project plans as assigned (Implementation of Initiatives either independently or with team)
- Proactively identify opportunities for process improvements and work collaboratively with project team incase further action required
- Complete required trainings according to required timelines
- Follow applicable departmental Standard Operating Procedures and Work Instructions
- Follow project issue escalation process and Labcorp Corrective Action Issue Resolution (CAIR) process for clinical operations issues
- Ensure follow up on issues and risks and protocol deviations and to be a liaison between CRA, CTL and PM for timely resolution of issues
- Responsible for the timely and appropriate communication to the clinical operations team Liaise with CTL/PM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety
- Review progress of project and initiate appropriate actions to achieve target objectives assigned
- Support in review of Standard Operating Procedures or Work Instructions to align with process or tool modifications
- Other duties as assigned by management: Ex: Document Review, ETMF reconciliation, other CTL tasks etc.
Labcorp is proud to be an Equal Opportunity Employer:
- 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)
- 10+ years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations
- Experience as a TRR is preferred but relevant experience will also be considered
- Fluency in English
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
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