Senior/ Clinical Research Associate (CRA) - Home based Sweden
Life Science People are a strategic growth partner within the Life Science industry, providing bespoke services to the life science community from SMEs through to blue-chip organisations and sourcing the best talent to make a tangible contribution to healthcare.
Do you want to become part of a company where they constantly share real-world knowledge and insights that lead to getting the job done better, smarter and faster? Are you looking to take that next step in your career? If so, this may be the role for you...
My client knows where people's lives are involved there is way more to be done. That is why every person working on a project is working hard to find innovative ways to overcome obstacles. It's this unwavering determination that keeps us delivering excellence every time!
We have an excellent career opportunity for a determined and motivated Senior Clinical Research Associate (CRA) who strives for excellence.
Responsibilities of the Clinical Research Associate (CRA):
- Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures
- Site management to ensure proper adherence to protocol, source data verification and assess CRF entries
- Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists
- Assist with study protocol design, development and / or review if required
- Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required
- Perform pre-study initiation, interim monitoring and close out visits as required
- Carry out drug formulation administration procedures and documentation records
- Ensure adequacy of drug shipment and drug accountability
- Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required
- Organise / attend investigator meetings as required
- Provide support to the Project Manager / Country Manager with ad-hoc tasks as require
- Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline
- Clear understanding of the drug development process
- Significant experience in performing a Clinical Research Associate role
- Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company
- Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials
- Ability to contribute to the development of clinical trial related documents and materials
- Ability to independently perform pre-study initiation, interim monitoring and close out visits as required
- Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines
- Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail
- Fluency in English and Swedish languages (both written and spoken)
- Ability to be home-based in Sweden with willingness to travel 8 days per month
- Experience across a wide range of clinical indications / therapeutic areas- oncology or opthamology.
- Ability and experience to work with an electronic case report form (eCRF)
- Membership of local professional bodies or international clinical groups
- Ability to mentor, train, supervise and inspire confidence in newcomers to the industry
Why Work For Us?
We believe our people are our greatest asset and understand that the best performance comes from individuals who know they are part of a valued team. You can expect to receive expert training and guidance throughout your career with us, with the opportunity to develop, progress and travel globally.
We can offer you:
- A competitive salary
- The opportunity to work with various global pharmaceutical leaders on the some of the most prestigious, ground-breaking and challenging drug development projects
- Real career development opportunities and a life-long career with an innovative, forward-thinking clinical research company
If this role interests you, then please apply now. We will send you a confirmation of acknowledgement, and please note feedback can take up to 2-3 weeks. Upon successful selection for an interview, the process will occur in the following three stages:
First stage: This will be an initial screening call with a Life Science People representative
Second stage: An initial phone call with the hiring manager - Managing Director to go through background and experience in relation to the role.
Final Stage: This will be a final interview with key stakeholders within the business.
The Senior Clinical Research Associate role is a full-time permanent position, paying up a competitive salary & benefits package.
Full details will be provided on application.
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