Hobson Prior are looking for an Inhouse CRA to join a biopharmaceutical organisation who are focused on developing novel, small molecule drugs.
Please note that to be considered for this role you must have the right to work in this location.
- You will assist in reviews and approvals of monitoring reports.
- You may conduct co-monitoring or observational visits at investigational sites.
- Supports with the preparation and finalization of investigators contracts, budgets and payments.
- Obtain, review and process essential regulatory, administrative documents, and Informed Consent Forms.
- Supports the global and regional clinical trial managers and trial leaders in the planning, execution and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines.
- Performs an array of assigned duties including investigative site recruitment/feasibility; essential document collection and review; ICF review; study document/plan development and review; maintenance and close-out of in-house site management activities in accordance with the protocol; standard operating procedures ICH/GCP guidelines and all applicable regulatory requirements.
- Works with Technical Operations and/or CTAs to Initiate investigational product shipments as needed and ensures that supplies are adequate/appropriate for assigned studies and sites.
- To collaborate with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply and clinical vendors as needed, to support clinical trial activities.
- You will support the Regional Clinical Trial Manager in start-up and management and oversight of vendors including the review of specifications, charters and plans
- Ongoing communication with clinical operations team members and Investigator site staff to obtain and relay key study issues, status updates and other study information to the clinical trial team and management.
- Contributes in development and improvement of department processes, best practices, and tools and templates related to clinical trial management and operations.
- You will participate in the review and development of CRFs and CRF guidelines.
- Performs in-house review of CRF data for completeness and accuracy, and resolves data management/query issues with study sites and vendors as needed.
- Analyses data to identify protocol deviations and risks to subject safety/data integrity.
- You will work with CTAs to obtain licensing for study tools and assessments.
- Performs other work-related duties as assigned or required.
- Strong written and verbal communication and computer literacy (eg, Microsoft Word, Excel, Powerpoint, Outlook); strong experience utilizing CTMS, EDC, TMS and related software.
- Motivated to work in a fast-paced, high accountability environment.
- Bachelor's degree, preferred.
- 5+ years of relevant and progressive experience with clinical trials.
- Experience in all stages of drug development/pharma and strong understanding of clinical trial processes, protocols and medical terminology.
- Prior experience in management and monitoring of CRO and investigative sites, preferred.
- Experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability.
- Knowledge of ICH GCP, IRB/IEC and local regulatory authority drug research & development regulations.
- Experience with bio-samples, storage of 3rd party data, preferred.
- Travel potentially up to 30%.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
£48000 - £55000 per annum
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