Clinical Research Associate
Há 2 dias
Tfs HealthScience, a leading global Contract Research Organization (CRO), seeks an experienced Clinical Research Associate to join our Strategic Resourcing Solutions team. As part of this role, you will work collaboratively with innovative professionals to ensure our customers achieve their clinical development goals.
The successful candidate will be responsible for initiating, on-site and remote monitoring, and terminating investigative sites during study conduct, adhering to company policies, SOPs, and regulatory requirements. You will conduct all stages of site monitoring, including feasibility, pre-study, initiation, interim, and close-out phases. Travel is expected, which may involve overnight and international trips.
Key Responsibilities:- Monitor clinical trials on-site and remotely in accordance with TFS and/or client company guidelines.
- Review CRFs (paper or electronic) and subject source documentation for validity and accuracy, generating queries to investigational sites/clients to resolve problem data.
- Identify site problems/deficiencies and report them to management through trip reports, memos, and verbal communication with Project Managers or Lead CRAs.
- Initiate corrective actions to resolve issues as directed by supervisors.
- Contribute to the completion of ethics committee/IRB applications, preparing necessary documentation according to local requirements in cooperation with CRAs and directed by Lead CRAs/Project Managers.
- Participate in contract handling and negotiation directed by Lead CRAs/Project Managers.
We are seeking a highly skilled and motivated individual with:
- A Bachelor's Degree, preferably in life sciences or nursing; or equivalent.
- Minimum 1-3 years of relevant clinical experience.
- Ability to work in a fast-paced environment with changing priorities.
- Understanding of basic medical terminology and science associated with assigned drugs and therapeutic areas.
- Familiarity with Good Clinical Practice regulations and ICH guidelines.
Tfs HealthScience began its journey over 27 years ago in Lund, Sweden. Today, we're a full-service, global Contract Research Organization (CRO) with over 800 professionals working across more than 40 countries. We deliver tailored clinical research services, flexible clinical development solutions, and strategic resourcing solutions across key therapeutic areas, including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decision-making at all levels, attracting and retaining valuable talent who share our sentiments. This unified force enables us to cultivate a culture of mutual respect and collaboration, driving innovation and excellence in our pursuit of making a difference.
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