(Senior) Clinical Research Associate, Study Start Up (BB-42020)
Found in: Neuvoo IL
PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.
Then you might be interested in the role of a:
The start-up is a very exciting but challenging period in the life-cycle of a clinical trial. Getting sites quickly and efficiently to the point where they can enroll subjects is crucial to the overall timelines of a study.
As a Start-up CRA, you will work on newly awarded projects. You are the initial contact with the site and you will conduct feasibility activities on a country level.
You will evaluate the site and bring it to the point where it is formally selected - or rejected. Your assessment will play a key role in the selection of appropriately qualified sites, thus contributing to the achievement of project operational goals and impacting on the success and profitability of the projects.
You will work closely with the Contracts Specialists and the Country Approval Specialist, under the supervision of the SPA Country Manager, and your shared goal will be to bring investigational sites to the point of initiation and enrollment timely and efficiently.
In order to be successful on this role you should have:
Education and Experience:
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
Valid driver's license where applicable.
Knowledge, Skills and Abilities:
- University level of education in a life sciences field
- Monitoring and contracts negotiations experience
- In-depth knowledge of ICH-GCP, EU and FDA requirements
- Willingness & ability to travel
- Excellent communication and team work skills – in order to establish good communication line between PPD and the site
- Flexibility and ability to work on multiple projects and to support tasks such as feasibilities, site contracts and budgets, submission documentation and contribute to regulatory country intelligence as required
- Experience of starting up clinical studies or contributing to start up tasks.
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
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