|Location: England||Salary: Negotiable|
|Sector: Pharmaceuticals, Client Delivery, Medical Devices, Life Sciences||Specialism:|
|Type: Contract||Contact: Jeremy Farley|
Job Title: Clinical Research Associate - Oncology
Location: Field Based
Term: 12 Month Contract
Day Rate: £DOE - Inside IR35
Key Skills: CRA, Oncology, Pharmaceuticals, Research, Trials ICH-GCP, GMP, GDP, Life Sciences, Clinical Study, Regulations
Clinical Research Associate - Oncology is required 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.
*Must hold a valid driving licence*
Some of the main duties of the Clinical Research Associate - Oncology 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 - Oncology?
- 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
My client is keen to get this position filled ASAP, so if you feel you have the skills and desire to provide passion and drive as the next Clinical Research Associate in Oncology, this is the opportunity for you!
So, if you are interested in joining a well-established, renowned, globally recognised organisation working with experts in their field as the next E Clinical Research Associate within Oncology, hit that apply button now!
Services advertised by Gold Group are those of an Agency and/or an Employment Business.