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Senior Clinical Research Associate (SCRA) FSP

Employer
Empatico
Location
Denmark
Salary
Excellent salary and benefits
Start date
15 Sep 2022
Closing date
15 Oct 2022

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Job Details

As a growing company, our client is one of the most exciting CROs in the global market. At this time, they have global representation in over fifty countries. They provide full-service CRO, FSP, Strategic Resourcing and Quality and Validation services. The business was started over twenty years ago with a mission to provide clients with a better clinical service. The core values of the business are Respect, Excellence, Accountability and Leadership.

The Senior Clinical Research Associate is acting as the primary contact and responsible for conducting monitoring activities at a clinical site(s) for a clinical trial(s) and will be assigned clinical monitoring activities in a single country or in several countries ensuring quality service and appropriate clinical study conduct, ensure subject safety and verify diligence in protecting the confidentiality of each subject.

This opportunity is to work within their full-service team working with multiple Sponsors.

Responsibilities:

  • Follow Protocol(s)/Amendment(s), Standard Operating Procedures (Company or Sponsor SOPs), Good Clinical Practice (ICH GCP), and local regulations per country
  • Guarantee the adequacy, the reliability and quality of the data collected from sites and shall participate in the quality control processes to ensure the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with any applicable regulatory requirements in the assigned countries.
  • Complete project-specific and other job-related trainings and attend client meetings as needed for the clinical trial
  • Perform source document verification, source data review, review regulatory documents and investigational product, and prepare monitoring visit reports, including confirmation and follow-up letter, as outlined in the Monitoring Plan
  • Ensures training compliance of site staff
  • Reconciliation between the Investigator Site File (ISF) and the Trial Master File (TMF) to ensure audit readiness
  • Support the submission to the Independent Ethics Committees (central and local) and when applicable to Competent/Regulatory Authorities
  • Participates to Investigators selection/feasibility process
  • Conduct different types of monitoring visits (pre-study visits, site initiation visits, interim monitoring visits & close out visits)
  • Develop and maintain site and investigator relationships to ensure clinical trials are managed efficiently
  • Adhere to monitoring metrics

Qualifications:

  • 3+ years of monitoring experience or combination of on-site monitoring and clinical research experience or education
  • The ideal candidate should have as a minimum a bachelor’s degree; a Registered Nurse (RN) or equivalent may also be considered
  • Experience in multiple therapeutic experiences
  • Must be able to communicate in the English language

What's in it for You?

  • Package includes a base salary plus bonus and paid time off
  • Typical CRA’s work 3-5 protocols and mostly travel only within their country of residence
  • Company that is dedicated to the mental health of its employee including access to Modern Health
  • Ability to attend a future Ovations Club trip that is directly depended on your performance. Last year trip was in Phoenix, AZ!
  • Quarterly CRA Incentive Plan
  • Wellness reimbursement up to €67/£57 per month for fitness and wellness memberships
  • Visibility and recognition by Senior leadership
  • Peer to peer mentorship
  • Ability to have full international reach across the business and not siloed to your country which directly aids the ability of career growth
  • Pension Scheme as per local requirements
  • And more!

#SCRA #seniorclinicalresearchassociate #cro #croscra #fullservice #multiplesponsors

BTH Recruitment are a boutique headhunting firm specialising in the Pharmaceutical and Clinical industry. Our core business focuses on small-medium sized life sciences businesses, sourcing and securing the highest calibre individuals in the market (i.e. you!). We pride ourselves on the consultative approach we take, supporting you to find the best next step for your career. Our friendly and professional approach is complimented by our in-depth industry knowledge and experience.

Company

We are a boutique, recruitment and selection company, specialising in three, bespoke offerings:

  • Executive retained search, where we will source, highly competent and fully screened candidates to fit your executive role perfectly;
  • Contingent recruitment where we will apply our significant experience and proven processes to produce a pre agreed number of qualified candidates for you to choose from;
  • Consultancy, where Empatico offers wide ranging HR and people management expertise, tapping in to our wide ranging and diverse associate talent pool, in order to provide you with the appropriate skills and experience to advise, guide and coach you towards your business goals and desired outcomes.

 

As our name would imply, our approach is to partner with our clients, over the long term, so that we are embedded in your business, understand your business drivers and challenges and are, therefore better able to source individuals that will fit with your culture and become high performers, over the long term.

Company info
Website
Telephone
02035877618
Location
1 Empire Mews
The Hideaway Workspace
London
Greater London
SW16 2BF
United Kingdom

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