TFS HealthScience is a leading general mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
**Join Our Team as a** **Lead Clinical Research Associate**
**About this role**
- As part of our _**_Strategic Resourcing Solutions (SRS)_**_ team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals._
The **Lead CRA**is responsible for coordinating and overseeing the country and site management activities during study conduct, according to company policies, SOPs and regulatory requirements in addition to financial and contractual obligations.
The Lead CRA may assist the Project Manager in certain aspects of project activities which may include country and site tracking, monitoring plans, review of monitoring reports and study monitoring resources management.
**Key Responsibilities**:
- Support the Project Manager being responsible and accountable for overseeing all aspects of monitoring and site Management activities ensuring compliance with ICH/GCP guidelines, SOPs and protocol requirements.- Lead, manage and guide CRAs being responsible for training and quality oversight of site management activities while proactively identifying potential operational issues and ensuring study deliverables.
- Development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing site and country Study Reports.
- Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out.
- Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison.
- Implement monitoring/recruitment plans and support also the design of CRF completion guidelines.
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**Qualifications: (Max 5-6)**
- Bachelor’s Degree, preferably in life science or nursing; or equivalent.
- Minimum 3 years of experience as CRA including relevant on-site monitoring experience.
- Able to work in a fast paced environment with changing priorities.
- Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas.
- Possess the understanding of Good Clinical Practice regulations, ICH guidelines.
- Ability to work independently as well as in a team matrix organization and multiple projects.
- Excellent written and verbal communication skills as well as computer skills.
- Excellent organizational and Line Management skills.
- Ability and willingness to travel up to 10-20%
**What We Offer**
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
**A Bit More About Us**
Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.
Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.
**#Together we make a difference