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Sr. CRA, Clinical Operations OBG

UK   •  Permanent, Full time

CK Group are recruiting for a Senior CRA, Clinical Operations to join a Global Pharmaceutical Company on a permanent basis.

The Role:
The main purpose of the role will be to:

  • Execute work procedures that are tactical in nature
  • Deliver work output with a direct, short-term impact on the job area or work team
  • Use professional concepts and company policies and procedures to solve a variety of problems
  • Contribute to the completion of milestones associated with specific projects
  • Be an individual contributor or first level supervisor of nonexempt employees responsible for executing specialized work processes that support functional and organizational strategy
  • Ensure that responsibilities are completed on schedule following established procedures and timelines
  • Interpret, translate and analyse facts. Present concepts, facts and approaches to internal parties to advise of key trends/issues
  • Work on problems of moderate scope and complexity in which analysis of situation or data requires a review of identifiable factors
  • Consistently exercise judgment and discretion within generally defined professional practices and policies in selecting methods and techniques for obtaining solutions
  • Primarily internal company contacts. Infrequent inter-organizational and outside customer contacts on routine matters
  • Work is completed under moderate supervision. Routine work may require little to no instruction
  • Plan and execute own area of responsibilities through predefined standards and objectives

Further responsibilities will include:

  • Executing study management activities including document review, data resolution and drug accountability
  • Tracking the progress of the studies using clinical trial management tools and systems
  • Ensuring quality data capture for assigned sites and escalates issues / concerns
  • Undertake co-monitoring activities and may be responsible for monitoring activities
  • Draft and / or contribute to study documents (e.g., site manuals, monitoring manuals, Informed Consent Forms (ICF), co-monitoring guidelines)
  • Provide input into protocol / CRF review
  • Serve as first point of contact for company to CROs and / or study sites
  • Contribute to CRO monitoring plans and monitor training and provide oversight of vendor activities and quality
  • Use available technology and resources (time, people, etc.) to complete work assignments
  • Complete work within set time frames
  • Track and has awareness of own individual expenditures to meet overall budget goals set by managers (e.g., travel and expenses)
  • Follow function\'s financial standards, guidelines and compliance requirements
  • Provide feedback to peers in a constructive manner
  • Support employees by participating in project initiation, work transitions, and other development activities
  • May conduct training where appropriate
  • Comply with all applicable laws / regulations of each country in which we do business
  • Demonstrate high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians
  • Report legal, compliance and ethical violations in a timely manner

Your Background:
To succeed in this role, you will have:
-BS/MS in relevant field
-Experience in clinical operations methods and processes in industry setting required

Entitlement to work in the UK is essential. Please quote reference 51086.

You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Aliza Qureshi
  • Phone: 01438 870022
  • Reference: 51086
  • Posted: 7th July 2021
  • Expires: 4th August 2021

CK Group

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