Our client, a global pharmaceutical employer, is recruiting for a Senior CRA to be based in Hatfield, UK. Specialising in oncology and neurology, the company is dedicated to improving patient healthcare worldwide.
This SCRA role assists the Clinical Operations Lead with the management of one or more Oncology clinical studies, ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission, through oversight of CRO and vendors. Ensures that the studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and the company's standard operating procedures.
- 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 analyzes facts. Presents concepts, facts and approaches to internal parties to advise of key trends/issues
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
- 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
- Uses available technology and resources (time, people, etc.) to complete work assignments
- Completes work within set time frames
- 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
- Complies with all applicable laws / regulations of each country in which we do business
- Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians
- Reports legal, compliance and ethical violations in a timely manner
Education and Experience:
- BS/MS in relevant field
- Experience in clinical operations methods and processes in industry setting required
- Oncology clinical trial experience in industry/CRO setting required.
- Experience of taking responsibility for multiple countries as international lead CRA, international monitoring team leader or similar in an Oncology setting strongly preferred.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jack O'Neill on +44 207 437 6824 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.