Clinical Research Associate
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Hobson Prior are looking for a Clinical Research Associate to join a biopharmaceutical organisation where you will work 1 day in the office and 4 day working from home. Our client is focused on developing specific therapies that harness the immune system to destroy cancer cells.
- Accountable to accelerate the sites 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.
- Self-sufficiently 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.
- You will manage multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
- 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.
- 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.
- Previous small pharmaceutical/biotech experience would be preferred.
- A 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.
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.
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