Senior Clinical Research Associate

TFS HealthScience is excited to be expanding our
Strategic Resourcing Solutions (SRS)
team and we are looking for an experienced, highly motivated
Clinical Research Associate
who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert.

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation.

Together we make a difference.

TFS HealthScience is looking for a
Clinical Research Associate/ Senior CRA
to be
home-based
in
the Netherlands
This is a permanent position with a focus on career progression and
dedicated to one of our biggest prestigious pharmaceutical clients!
We look forward to receiving your application soon!

What can we offer you?

A great place to work where you will get the chance to push your career to the next level, a global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. UK benefits include:

• Private Health Coverage
• Corporate Pension Plan
• Global General Liability Insurance
• Global Travel Insurance
• Homebased Allowance for home-based employees
• Lunch Allowance
• Car Allowance
• Flexible working schedule

What We Offer:

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us:

Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.

#Together we make a difference

Responsibilities

• Obtain and maintain essential documentation in compliance with ICH-GCP, TFS procedural documents and local regulations both in the trial master file (TMF) and investigator study file (ISF).
• Actively participate in local study team meetings.
• Contribute to the selection of potential investigators.
• Train, support and advise investigators and site staff in study-related matters.
• Contribute to national investigators meetings.
• Initiate, monitor and close study sites in compliance with TFS procedural documents. Share information on patient recruitment and study site progress within the local study team.
• Drive performance at the sites. Proactively identify study-related issues, and solutions and escalate as appropriate.
• Update CTMS and other systems with data from centres as per required timelines.
• Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
• Perform source data verification according to SDV plan.
• Oversee data query resolution by the site.
• Verify accurate and timely reporting of serious adverse events.
• Prepare for activities associated with audits and regulatory inspections in liaison with the local study delivery team lead and CQM.
• Provide the required monitoring visit reports within the required timelines.
• Support and work together with lead CRA, LSM and regulatory affairs to see to timely delivery of study documents for submissions to RA and EC.
• Contribute to financial agreements with relevant staff at the investigational site in collaboration with the lead CRA and/or LSM.
• Oversee timely preparation of country-specific CSA in collaboration with LSM and/or lead CRA.
• Verify compliance with TFS’s code of conduct and company policies and procedures relating to people, finance, technology, security and safety, health and environment.
• Track and manage agreed payments at study site level.
• Participate in training and mentoring of new members of the local study team verifying compliance with ICH/GCP and TFS procedural documents.

Requirements

• Bachelor’s Degree, preferably in life science or nursing; or equivalent
• Previous experience as CRA including relevant independent

on-site monitoring

• Study experience in any of the following therapeutic areas: Oncology, Cardiovascular, Renal and Metabolism, Respiratory or Immunology.
• Able to work in a fast-paced environment with changing priorities

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