Clinical Research Associate

Job Description

We are currently looking for a highly skilled and motivated CRA to share our mission to execute clinical research in an innovative efficient high quality and compliant manner to improve and save lives around the world.

As a CRA you will part of an engaged team ensuring excellence in our clinical trials and site performance. Consequently you will have considerable responsibility and play an important part in ensuring successful clinical trials. We are looking for a new colleague who is eager to learn and who does not shy away from a challenge. You will be part of a fast-paced team full of positive and experienced people.

Bring energy knowledge innovation to carry out the following:

• Perform clinical study site management and monitoring activities in compliance with International Conference on Harmonisation Good Clinical Practice Sponsor Standard Operating Procedures Local Laws & Regulations Protocol Site Monitoring Plan and associated documents.
• Gain an in-depth understanding of the study protocol and related procedures.
• Coordinate and manage various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participate and provide inputs on site selection and validation activities.
• Perform remote and on-site monitoring and oversight activities using various tools to ensure:
  • Data generated at site are complete accurate and unbiased.
  • Subjects right safety and well-being are protected.
• Conduct site visits including but not limited to validation visits initiation visits monitoring visits close-out visits and records clear comprehensive and accurate visit and non-visit contact reports appropriately in a timely manner.
• Collect review and monitor required regulatory documentation for study start-up study maintenance and study close-out.
• Communicate with Investigators and site staff on issues related to protocol conduct recruitment retention protocol deviations regulatory documentation site audits and inspections and overall site performance.
• Identify assess and resolve site performance quality or compliance problems and escalate per defined Clinical Research Associates Escalation Pathway.
• Manage and maintain information and documentation to timelines.

What skills you will need:

In order to excel in this role you will more than likely have:

• Bachelors degree (or above) together with at least 2 years of direct site management
  (monitoring) experience in a bio / pharma / CRO OR associate degree certificate or equivalent in a scientific / healthcare discipline together withat least 5 years of relevant experience in the healthcare field including at least 2 years ofdirect site management (monitoring) experience in a bio / pharma / CRO.
• Ability to travel domestically. 50% of their working time
• Hold a valid drivers license
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks
• Capable of leading and mentoring CRAs on process/study requirements
• Work effectively in a multicultural environment. Ability to establish and maintain relationships.
• Fluent in English and excellent communication skills including the ability to understand and present technical information effectively

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs.

As an equal opportunity employer we are proud to be a company that embraces the value of bringing diverse talented and committed people together.

Please dont hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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Relocation:

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