Senior Clinical Research Associate
An opportunity has opened for 5 x SCRAs/ CRA IIs to join an emerging cell therapy Biotech in the UK. This company have grown rapidly in the last year with more than doubling the size of their Clinical Operations team. These are unique opportunities that do not arise often where they truly offer you the chance to develop quickly in your career whilst working in the cutting-edge cell therapy space. The sites for these positions are across London and Manchester areas so CRAs based in either of those locations are preferred for regional monitoring purposes.
- Expedites the site qualification and study site initiation processes including the conduct of Site Qualification and Site Initiation visits.
- Conducts Site Initiation visits in collaboration with Medical Monitors and/or Clinical Project Managers where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements regularly.
- Independently performs monitoring visits including site initiation, qualification, routine monitoring and close out visits
- Critically reviews and analyses site activities through frequent visits and contacts to monitor study sites following the applicable study plans and applicable SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations.
- Demonstrated skills and competencies
- Ensures quality of data submitted from study sites, collects data from sites within established timelines and ensures timely follow up/submission on any requested information
- Works across functions in the Company to ensure the readiness of supply kits
- Ensures site compliance, safety and protection of study patients according to the clinical study plans, SOPs, and ICH and/or FDA GCP Guidelines. Works with site personnel/study team to prevent address and resolve issues
- Reviews adverse event reports (where required) and ensures site reporting of safety events in a timely manner
- Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.
- Interacts and builds professional and collaborative relationships with all study personnel (study coordinator, investigator, pharmacist & cell therapy team members), peers and office-based personnel.
- Supervises overall activities of site personnel over whom there is no direct authority and motivates /influences them to meet study objectives. Provides full support to study sites to facilitate study conduct successfully
- Proactively communicates and escalates with all internal and external stakeholders any serious or outstanding issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.
- Ensures documented follow-up to all outstanding issues, within the scope of this position profile. Anticipates and proactively solves study site problems/issues as they occur.
- Previous small pharmaceutical/biotech experience preferred.
- Minimum of 3-5 years' monitoring experience, working as a CRA.
- Experience in monitoring oncology early phase studies
- Experience with ATIMPs an advantage
- Strong clinical, technical or disease area expertise
- Knowledge of medical terminology and clinical patient management.
- Bachelor's degree (BSc, BA or RN equivalent) in biological or science-related field is essential
- A valid driving license.
- Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and service providers
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
- Excellent communication, interpersonal and organisational skills
- Effective problem-solving skills
- Attention to detail and meet specified timelines
- Computer literacy, proficiency in Microsoft Office. Preferably experienced with the use of eCRFs
- Ability to work independently and to effectively prioritise tasks
- Able to think ahead and anticipate needs before they arise
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