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- Tasks: Join us as a Regulatory & Study Start Up Specialist, managing clinical trial submissions and site activations.
- Company: RBW Consulting partners with a leading mid-sized CRO, offering innovative solutions in clinical research.
- Benefits: Enjoy remote work flexibility and a negotiable rate for this 4-month contract role.
- Why this job: Make an impact in clinical trials while working independently and collaborating with diverse teams.
- Qualifications: Proficiency in UK regulatory submissions and recent experience in clinical trial processes are essential.
- Other info: Opportunity to expand your knowledge and skills in a dynamic and supportive environment.
The predicted salary is between 36000 - 60000 £ per year.
RBW Consulting are partnered with a leading mid-sized CRO in their search for a Regulatory & Study Start Up Consultant to work remotely in the UK. This is an initial 4 month contract for an estimated 0.7 FTE. Rate is negotiable. Must haves Be proficient in preparing regulatory submissions in the UK (combined review through IRAS, Radiation assurance, ARSAC). Must have proven recent experience on this, and be able to work independently on this (ie: completing medicines form, radiation form, providing advice on required documents for regulatory submissions, etc). Be proficient in creating budget using Interactive Costing Tool (iCT) in CPMS. Be proficient in performing country adaptation for the UK for ICF’s. Duties Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. Interaction with CA/EC for study purposes and handling responses to the CA/EC. Providing regular updates about CA and EC submissions to Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant. Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. Prepare/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration. Review and manage collection of essential documents required for site activation/IMP release. Customize country/site specific Patient Information Sheet and Informed Consent Forms. Responsible for/facilitates the translation and co-ordination of translations for documents required for submission. Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables. Act as SME for collection and maintenance of site level critical path to IMP Release data points such as Competent Authority, local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country. When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. May support the clinical team performing Pre-Study Site Visits May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. May support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors. May support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries. May interact with clients to provide activation readiness status updates, request documents or document review and participate in proposal activities, including slide development and client presentation as required. Consultant may be asked to undertake other related duties as may be needed. Apply here and Harry Henson will be in touch to discuss your application further!
Regulatory & Study Start Up Specialist - UK - 0.7 FTE employer: RBW Consulting
Contact Detail:
RBW Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory & Study Start Up Specialist - UK - 0.7 FTE
✨Tip Number 1
Make sure you are up-to-date with the latest UK regulatory requirements and guidelines for clinical trials. Familiarize yourself with the specific processes involved in preparing regulatory submissions, as this will demonstrate your expertise during discussions.
✨Tip Number 2
Network with professionals in the CRO industry, especially those who have experience in regulatory affairs. Engaging with others in the field can provide valuable insights and potentially lead to referrals or recommendations.
✨Tip Number 3
Highlight your proficiency with the Interactive Costing Tool (iCT) in CPMS during conversations. Being able to discuss your experience with budgeting and cost management will set you apart from other candidates.
✨Tip Number 4
Prepare to discuss specific examples of how you've successfully managed site activation readiness in previous roles. This will showcase your ability to foresee and mitigate risks, which is crucial for this position.
We think you need these skills to ace Regulatory & Study Start Up Specialist - UK - 0.7 FTE
Some tips for your application 🫡
Highlight Relevant Experience: Make sure to emphasize your recent experience in preparing regulatory submissions in the UK. Detail your proficiency with IRAS, Radiation assurance, and ARSAC, as well as any specific examples of successful submissions you've managed.
Showcase Technical Skills: Clearly outline your skills in using the Interactive Costing Tool (iCT) and your ability to perform country adaptations for Informed Consent Forms (ICFs). Providing specific instances where you've utilized these tools will strengthen your application.
Detail Your Responsibilities: In your application, describe your previous roles and responsibilities related to site activation readiness, project plans, and regulatory intelligence tools. This will demonstrate your capability to manage timelines and quality effectively.
Communicate Your Knowledge: Convey your understanding of local clinical trial laws and regulations. Mention any training or knowledge-sharing initiatives you've been involved in, as this shows your commitment to maintaining up-to-date knowledge in the field.
How to prepare for a job interview at RBW Consulting
✨Showcase Your Regulatory Expertise
Make sure to highlight your proficiency in preparing regulatory submissions in the UK. Be ready to discuss specific examples of your experience with IRAS, Radiation assurance, and ARSAC, as well as any challenges you've faced and how you overcame them.
✨Demonstrate Independent Work Skills
Since the role requires working independently, prepare to share instances where you've successfully managed projects or tasks on your own. Emphasize your ability to complete medicines forms and provide advice on required documents without needing constant supervision.
✨Familiarize Yourself with Budgeting Tools
Be prepared to discuss your experience with the Interactive Costing Tool (iCT) in CPMS. If possible, bring examples of budgets you've created and explain your approach to ensuring accuracy and compliance with project requirements.
✨Stay Updated on Local Regulations
Show that you have a solid understanding of local clinical trial laws and regulations. Discuss how you keep your knowledge current and how you plan to share this information with the team to ensure compliance during the study start-up process.
