Clinical Research Associate - Biopharma

Clinical Research Associate - Biopharma

Field Based

12 Month Contract

Brief

Clinical Research Associate - Biopharma needed for a highly reputable Pharmaceutical organisation who are looking to employ an experienced and well-rounded Clinical Research Associate that takes pride in their work with an in-depth knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP, good knowledge of relevant local regulations and good understanding of Clinical Study Management including monitoring, study drug handling and data management.

*Must hold a valid driving licence*

What the role entails:

Some of the main duties of the Clinical Research Associate - Biopharma will include:

• Contributes to the selection of potential investigators.
• In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
• Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
• Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
• Actively participates in Local Study Team (LST) meetings.
• Contributes to National Investigators meetings, as applicable.
• Initiates, monitors and closes study sites in compliance with company Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
• Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
• Updates CTMS and other systems with data from study sites as per required timelines.
• Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
• Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSM the correct timing and type of visits.
• Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
• Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.

What experience you need to be the successful Clinical Research Associate - Biopharma:

• Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (*).
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Good medical knowledge and ability to learn relevant company Therapeutic Areas.
• Basic understanding of the drug development process.
• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
• Excellent attention to details.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Good negotiation skills.
• Ability to travel nationally/internationally as required.
• Valid driving license

This really is a fantastic opportunity for a Clinical Research Associate - Biopharma to progress their career. If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!

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