Description:
Sr. Clinical Research Associate

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Sr. Clinical Research Associate for one of our clients based in the Randstad area of the Netherlands. You can work home-based or office-based.

For our client-facing positions, you must be confident, be able to drive the role and to work autonomously. You will have a close relationship with our Line Managers, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on studies for just one client. We are open, friendly and approachable and aim to support you through the recruitment process every step of the way.

Job Description


The Sr. Clinical Research Associate will identify, select, initiate and close-out appropriate investigational sites for clinical studies. The successful candidate(s) will monitor these sites in order to ensure ensuring compliance to the study protocol, Standard Operating Procedures, applicable regulations, and the principles of ICH-GCP. The Sr. CRA will also be charged with ensuring the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.

Responsibilities

• Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures
• Site management to ensure proper adherence to protocol, source data verification and assess CRF entries
• If required, support the gathering of documentation and information to gain appropriate regulatory and ethical committee approval where required
• Perform pre-study, initiation, monitoring and close out visits as required
• Ensure adequacy of drug shipment and drug accountability and carry out drug reconciliation
• Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required
• Organise/attend investigator meetings as required
• Provide support to the Project Manager/Country Manager with ad-hoc tasks as required
  

Requirements:

• Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline
• Clear understanding of the drug development process
• Minimum of 3 years of experience in performing a Clinical Research Associate role
• Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company
• Ability to independently perform pre-study initiation, interim monitoring and close out visits as required
• Good communication skills Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail
• Fluency in English and Dutch (both written and spoken)
• Willingness and ability to travel
• Willingness and ability to be home-based in Netherlands.
  

Preferred requirements:

• Experience across a wide range of clinical indications / therapeutic areas
• Ability and experience to work with an electronic case report form (eCRF)
• Membership of local professional bodies or international clinical groups

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001958 . If you would like to discuss the role before applying through the website, please contact Julie.casteleijn@cromsource.com for more information.


The Benefits of Working for TalentSource in The Netherlands

• Competitive Salary
• Group health insurance
• Great pension scheme
• 25 Holidays per annum
• Internet reimbursement
• Company Car with fuel card depending on the function
• Dedicated Line Manager
• Monthly meetings with line manager
• Full performance and development process with end of year reviews
• Team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

Why choose TalentSource Life Sciences/CROMSOURCE?

TalentSource Life Sciences is a fully dedicated flexible resourcing department at CROMSOURCE, a family owned international, full-service Contract Research Organisation. CROMSOURCE comes from the merger of MSOURCE and CROM and we have been supporting clients with outstanding clinical research and resourcing services since 1994. Successful growth has been achieved by putting high quality and client focus at the heart of everything we do and we are proud to partner with industry leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide.

Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our current below industry average turnover rates.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are experts providing experts - highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world.

How can we help you on your next career move? Learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Skills: Clinical Research Associate, Senior Clinical Research Associate, ICH-GCP Location: Netherlands, Amsterdam area