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. Ensures that the studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and the company standard operating procedures.
Accountabilities: Executes work procedures that are tactical in nature Delivers work output with a direct, short-term impact on the job area or work team Uses professional concepts and company's policies and procedures to solve a variety of problems Contributes 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 Ensures that responsibilities are completed on schedule following established procedures and timelines Interprets, translates and analyses facts. Presents concepts, facts and approaches to internal parties to advise of key trends/issues Complexity / Innovation: Works on problems of moderate scope and complexity in which analysis of situation or data requires a review of identifiable factors Consistently exercises 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. Plans and executes own area of responsibilities through predefined standards and objectives Clinical Trial Execution: Executes study management activities including document review, data resolution and drug accountability Tracks the progress of the studies using clinical trial management tools and systems Ensures quality data capture for assigned sites and escalates issues / concerns Undertakes co-monitoring activities and may be responsible for monitoring activities Document Creation and Management: Drafts and / or contribute to study documents (e.g., site manuals, monitoring manuals, Informed Consent Forms (ICF), co-monitoring guidelines) Provides input into protocol / CRF review CRO / Vendor Management: Serves as first point of contact for the company to CROs and / or study sites for regional or contributes to CRO monitoring plans and monitor training and provides oversight of vendor activities and quality Resource Management: Uses available technology and resources (time, people, etc.) to complete work assignments Completes work within set time frames Financial Management: Tracks and has awareness of own individual expenditures to meet overall budget goals set by managers (e.g., travel and expenses) Follows function's financial standards, guidelines and compliance requirements Matrix and Team Management: Provides feedback to peers in a constructive manner Supports employees by participating in project initiation, work transitions, and other development activities May conduct training where appropriate Compliance: Complies with all applicable laws / regulations of each country in which business is done. Demonstrates high ethical behaviour at all times, whether dealing with colleagues, vendors, patients, or physicians Reports 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 email@example.com. 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 CL33503 in all correspondence.