Senior Clinical Research Associate (SCRA) FSP

Employer
BTH Recruitment
Location
Germany
Salary
Excellent salary and benefits
Start date
17 Nov 2022
Closing date
17 Dec 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

BTH - logo

overview

BTH Recruitment was founded in 2014 with a vision of providing global strategic recruitment solutions to a select group of the pharmaceutical industry’s most exciting and innovative organisations. Seven years later, we have achieved this goal with a vigorous and unflinching focus on quality of service, and a delivery-focused, people centric approach that is authentic and engaging. 

Our recruitment service covers mid-level roles through to executive projects. Each project is tailored to ensure your role, team and business is being effectively marketed and communicated via the most engaging recruitment tools by our market-leading consultants. 
Our recruitment solutions focus on Retained/Executive Search, Interim and Freelance projects and Contingency.

We pride ourselves on our expertise, honesty and integrity.

our team

Ben Northfield
Managing Director. Account Director. Global Project Leader 
25 years business, management and consulting experience. 16 years recruitment experience dedicated to life sciences. Ben oversees and delivers global projects whilst also consulting with industry leaders on recruitment process, on-boarding, salary surveys, change management and succession planning

Yvonne Mallett
Senior Recruitment Consultant, Account Director
14 years recruitment and delivery experience, covering both in-house and boutique recruitment services. Yvonne has delivered projects for companies of all sizes from entry level through to Executive, of varying complexities, across Europe, the Americas and Asia Pacific

Rebecca Carmichael
Recruitment Consultant and Interims Manager

Rebecca brings a wealth of organisational, contracts and operational experience. She leads entry and mid-level projects across Europe, coordinates our large pool of freelance and interim projects, as well as supporting senior projects.

where can we support you

Over the last two years we have placed candidates in the following Continents:

Europe/EU - UK, France, Germany, Spain, Italy, Belgium, Netherlands, Austria, Switzerland, Poland, Greece, Georgia, Portugal, Ukraine, Moldova, Slovakia, Romania, Latvia, Czech,Bulgaria, Tunisia, Israel, Hungary,Turkey and Russia

USA - Boston, New York (Rochester, Manhattan, Syracuse), North Carolina, Alabama, California, Seattle, Maine, Denver, Florida, Tulsa, Louisiana, Cincinnati, Denver 

Asia Pacific - China, Australia, New Zealand, Inner/Outter Mongolia, Sri Lanka, Thailand, Philippines

South America - Mexico, Peru, Brazil, Colombia, Argentina

Scandinavia - Finland, Denmark, Sweden

Africa - South Africa

How Can We Help You?

Changing jobs or taking your career in a new direction can be a very daunting prospect. At BTH we develop long-term relationships by building an understanding of where you are in your career, how you got there and where you wish to go by providing you with ongoing career consulting and advice.

We are friendly, professional and methodical in our approach. Punctuality, honesty and transparency are central to our interaction with you. Our consultants will guide you on the structure of your CV and interview preparation, right through to offer negotiation, giving your notice and supporting you as you embark upon the next important step in your career.

 

testimonials

Neurology Consultant

I have known and worked with Ben and his team at BTH for many years now while I was at global CRO and most recently as a consultant for a leading AI/tech business. Ben identified and successfully recruited 2 very senior positions for us - and ensured that they were a good fit for this small vendor. These were made in a timely manner and actually all the proposed candidates could have fitted into these roles…it was much appreciated to have a choice of candidates!

Key to BTH successes is the fact that they know and fully understands the pharmaceutical industry landscape: from recruiting to the large, mid-sized and small Pharma’s, the biotechs, the CROs and the vendors (e.g. scales, imaging, ECG, labs etc). All these institutions have differing cultures, needs, roles and responsibilities - even for the same job title - and thus knowledge of these inherent differences by BTH really means that the recruitment process is much more targeted and streamlined to the appropriate candidate. We recruited an SVP Ops and Chief Commercial Officer really quickly - with a good selection of candidates even at these senior positions. Careful pre-interview assessment by BTH ensured that we only saw real candidates and, they also know a good number of these people personally thanks to the depth of experience in the business. This personal approach makes a huge difference and inspires confidence when you make senior, or other level, offers.

I consult for a number of other clients and will be approaching BTH when we start to recruit more fully for these global initiatives. I cannot recommend them more highly.

Non-Exec Director, Member of Supervisory Board, Independent Consultant

I first got to know Ben and his team when working as a consultant for growing tech business. They had selected Ben and his team as they stood out as a thorough, hard-working, very well connected group on previous searches for them. Ben’s delivery on two key searches I was involved in did not disappoint; his work was exceptional as were the appointments we made. BTH’s attention to the client and buy into the process was of a level I have rarely seen in my experience. I wouldn’t hesitate to recommend Ben and his team for any board or executive hires in the Life Science industry.

CEO of global CRO

I have worked with Ben and the BTH team whilst at three different organisations on a variety of Operations and Commercial roles. He has a good network and has always delivered on his commitments. We have hired some great candidates thanks to him and his team. Ben is also extremely responsive and provides regular feedback on the process. I would be happy to recommend him and BTH Recruitment to a colleague.

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

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