Senior Clinical Research Associate
An opportunity has opened for a Senior Clinical Research Associate to join a global pharmaceutical company. In this role you will be expected to be involved in SIVs, COVs, PSSVs and on-site monitoring visits. The sites for these positions are across the United Kingdom.
- 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.
- 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
- 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
- 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.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.