Russell Oakley at CK Clinical is currently looking for a Snr CRA to join a large pharmaceutical company based in Hertfordshire. This role is an in-house office based monitor and is not a field based role.
The Snr CRA assists the Clinical Operations Lead with the management of one or more clinical studies within the Oncology PCU, ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is acceptable and suitable for regulatory submission. Ensuring that the studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and the company standard operating procedures.
Accountabilities: 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's policies and procedures to solve a variety of problems Contribute to the completion of milestones associated with specific projects 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
Complexity / Innovation: 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
Communication: Primarily internal company contacts. Infrequent inter-organizational and outside customer contacts on routine matters
Supervision Given / Received: 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
Clinical Trial Execution: Execute study management activities including document review, data resolution and drug accountability Track the progress of the studies using clinical trial management tools and systems Ensure quality data capture for assigned sites and escalate issues / concerns Undertake co-monitoring activities and may be responsible for monitoring activities
Document Creation and Management: 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
CRO / Vendor Management: Serve as first point of contact for the company to CROs and / or study sites for regional or contribute to CRO monitoring plans and monitor training and provide oversight of vendor activities and quality
Resource Management:Use available technology and resources (time, people, etc.) to complete work assignments Complete work within set time frames
Financial Management: Track and have 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
Matrix and Team Management: 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
Compliance: Comply with all applicable laws / regulations of each country in which business is done. Demonstrate high ethical behaviour at all times, whether dealing with colleagues, vendors, patients, or physicians Report legal, compliance and ethical violations in a timely manner
Education Guidelines: BS/MS in relevant field
Core Experiences: Experience in clinical operations methods and processes in industry setting required Oncology clinical trial experience in industry/CRO setting required. Experience as international lead CRA, international monitoring team leader or similar in an Oncology setting strongly preferred.
For more information or to apply for this position please contact Russell Oakley on 01246 457733 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL33828 in all correspondence.