Clinical Research Associate – UK

Excelya>All job opportunites>Freelance, part-time>Clinical Research Associate – UK

Job description

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

The role:

The Clinical Research Associate (CRA) is responsible for ensuring that the conduct of a clinical trial at selected investigational sites is according to the currently approved protocol/amendments, ICH-Good Clinical Practice guidelines, the Standard Operating Procedures (SOPs) and the applicable laws and regulations. Among his/her responsibilities, the most important ones are to ensure that the subject’s rights are respected and that all collected clinical trial data are accurate, complete and verifiable from source documents.

The Senior CRA additionally supports in submissions, site selection and contracting where needed.

Job responsibilities:

  • Contributes to the study start up where needed, a.o. selection of potential investigators, (assisting in) site contracting and obtaining country and site approval.
  • Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management principles.
  • Actively participates in Local Study Team meetings.
  • Drives performance at the sites. Proactively identifies and ensures timely resolution of study-related issues.
  • Manages study supplies, drug supplies and drug accountability at study site.
  • Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan.
  • Performs Source Data Review, Case Report Form review and Source Data Verification, in accordance with the Monitoring Plan.
  • Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
  • Ensures data query resolution in a timely manner.
  • Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc) are available and ready for final archiving and completion of local part of the eTMF.
  • Dependent on level of experience you may assist in training and mentoring less experienced CRA’s and taking on additional local project management responsibilities and tasks.

Minimum Requirements :

  • University or College graduate (bachelor’s degree in life and/or health sciences is preferred – post graduate studies in a relative field are considered as a plus).
  • At least 4 years of experience as CRA.
  • Experience in CEC approval process
  • Experience in contract negotiation with sites
  • Good communication and organization skills, focus to detail, time management and multi-tasking.
  • Fluent in English.
  • Very good knowledge of PC.

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