Your new employer is Covance Inc., the drug development business of LabCorp®, the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real ® . Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, along with our innovative technology solutions, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
This is your chance to become part of a team that helps to bring the miracles of medicine to market sooner. Excellent opportunity for an Associate Project Coordinator to join our Phase I Clinical Research business in Leeds, West Yorkshire on a full-time and permanent basis . This is a great opportunity to develop your career within Clinical research/trials and allow you to continue to practice your clinical skills and knowledge. You will be supporting Project Manager focused on early phase studies.
Your main responsibilities will include but not be restricted to:
Work with a more senior PC or PM in developing study specific documents ( e.g., Project Management Plan, Communication Plan, Investigator Package Plan, Risk Register, Project Specific Training Matrix and any other applicable plans as required), including compliance with client-specific requirements for low complex studies; distributes them to the study team and/or sponsor for review, compiles comments, and routes final documents.
Maintain an internal standardized filing structure for study-related documents; pro-actively maintains documents within the filing structure.
Responsible for project setup activities ( e.g., study ID request, SAS Environment Setup request, eTMF, Study-specific Distribution Lists, etc.).
Attends and assists in the organization of study-related meetings, as required; distributes meeting agendas; maintains and distributes meeting minutes, Project Log, Risk Register, and study team contact lists; participates in client visits as needed.
As directed and with oversight, assists with business improvements initiatives to drive quality, productivity, and continuous improvements across different business units.
Upon PM request and with Associate Project Coordinator (PC) acceptance, may serve as a sponsor and site contact in the absence of the PM, primarily during maintenance phases of routine single and multi-site low-complexity trials.
Assists the PM or a more senior PC with payments per global finance standards.
Assists in the set-up, coordination and maintenance of sponsor/internal training in accordance with applicable SOPs and processes.
Assists in the development of project tools as required for the project ( e.g., screening and enrolment log and development of investigator training).
Assists the PM, or more senior PC as required with feasibility, including providing sites with feasibility questionnaire and tracking responses.
Assists the PM/more senior PC in maintaining overall project trackers, including financial, screening, and vendors. Education/Qualifications:
What you will need:
To be a successful applicant considered for this position, you will hold a degree or equivalent qualification in a scientific discipline. Clinical research experience may be substituted for education. Experience: Minimum Requirements: Knowledge of the clinical trial process with early clinical pharmacology experience preferred Previous experience in a research environment Previous experience working in a project management environment. Knowledge of protocol designs, study objectives, study procedures, and project-related timelines Knowledge of GCP/ICH Guidelines and applicable Regulatory Authority Guidelines would be beneficial.