A degree in science or a healthcare-related discipline is required., 4 to 5 years of experience as a Senior Clinical Research Associate in the pharmaceutical or CRO industry is preferred., Solid knowledge of drug development processes, clinical trial monitoring procedures, GCP guidelines, and medical terminology is essential., Ability to work autonomously and show initiative is necessary..
Key responsabilities:
Act as the primary link between sites and sponsors, performing start-up, initiation, monitoring, and close-out visits.
Monitor all aspects of studies to ensure compliance with GCP, study protocol, and regulatory requirements, and prepare monitoring reports.
Develop and review study protocols and other study-related documents.
Prepare ethics submissions and assist in the preparation of Clinical Study Reports.
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About Avance Clinical
Avance Clinical is a full-service CRO for biotechs with a proven track-record for delivering clinical excellence in Australia, New Zealand, Asia, North America and Europe. Avance Clinical specializes in delivering top-tier clinical trials that yield globally accepted data.
Award-winning CRO for Biotechs
Avance Clinical has been recognized for the fourth consecutive year by Frost & Sullivan in 2023, being awarded the Best Practices Customer Value Leadership for Biotech’s award, for its continuous exceptional performance.
Pre-clinical through to Phase I and Beyond
Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia and highly qualified sites and networks within the United States. With experience across more than 120 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable for FDA and EMA review.
Technology
Avance Clinical uses state-of-the-art technology and gold-standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, Zelta, Veeva and Medrio are just some of Avance Clinical’s technology partners.
www.avancecro.com
Avance Clinical - our most important asset is our people. We offer a work environment and a culture that values honesty and respects its people.
Avance Clinical is a Contract Research Organization which offers specialized services supporting clinical drug development for the pharmaceutical and biotechnology industry.
Opportunity
This is a full-time permanent position for a Senior Clinical Research Associate I based in the US. We are looking for candidates specifically in Minneapolis Minnesota.
As we continue to grow, we want our people to grow with our organization. We offer training and career development opportunities to build the skills and progress the careers of our employees.
Responsibilities
Acting as the primary link between sites and sponsor, you'll be responsible for:
Performing start-up, initiation, monitoring, and close-out visits along with maintaining appropriate documentation
Developing your skills and knowledge on clinical trials within a wide scope of therapeutic areas
Monitoring all aspects of studies to ensure compliance with GCP, study protocol and regulatory requirements, and prepare monitoring reports
Development and review study protocols and other study-related documents
Preparing ethics submissions and assisting in the preparation of Clinical Study Reports.
Requirements
Prior experience monitoring clinical trials.
A degree in science or other healthcare-related discipline,
Ideally between 4 to 5 years of experience working as a SCRA in the pharmaceutical or CRO industry.
Solid knowledge of drug development process, clinical trial monitoring procedures, GCP guidelines, and medical terminology are essential.
On top of this, you will need to be able to show initiative and work well autonomously, within minimal supervision.
What we offer
Stimulating work
Project diversity
An intellectual challenge
An agile & flexible workplace
Opportunity to progress
Stability
Sense of community
A leadership team that are working together on a common goal
Flexible work options
Great tools / tech to do your job
A competitive salary
What next?
As a growing business we’re looking for likeminded people to join us - we hope that’s you.
To join our team please submit your CV & cover letter as one Microsoft Word document
To apply for this role please click on the 'APPLY' link and submit your CV along with a cover letter. The cover letter should document why you would make a great addition to the Avance Clinical team. Please submit the CV and cover as one document.
As we receive a high volume of applications for our vacancies, we will only contact you directly, should you be successful through to the next stage of our recruitment process.
No agencies please
Required profile
Experience
Industry :
Biotech: Biology + Technology
Spoken language(s):
English
Check out the description to know which languages are mandatory.