Reference: 05/2018
Deadline for submission of applications: 28/02/2018
Number of vacancies: 1
Desired Skills and Experience:
A Quality Clinical Trials Technician with experience in Good Clinical Practice Quality Assurance or Clinical Research Associate, preferably a Bachelor’s degree in life sciences (e.g. Pharmacy, Biology, Biotechnology).
Experience in quality inspection, auditing and testing as well as implementing corrective action programs.
The candidate must possess strong Excel, Word, Power Point and database skills.
The successful candidate will also have excellent knowledge of QA tools, concepts, methodologies and relevant regulatory requirements.
Fluency in both oral and written English is mandatory.
Background in Medical Oncology will be favorably considered.
The candidate must possess strong verbal and written communication skills, be a team player with the ability to prioritize. He/she must be organized and detail- oriented with strong analytical skills. This position demands the necessary skill set to work both independently and as a team member.
Main Roles and Responsibilities
Assisting in the creation, review, revision and management of standard operation procedures in clinical trials.
Assisting with the organization for regulatory inspections and audits – pre-planning, coordination, compilation of required documentation, the hosting and conducting of these activities, and follow-up.
Collect and compile quality statistical data.
Document internal audits and other quality assurance activities.
Analyze data to identify areas for improvement in the quality system.
Interpretation and implementation of quality assurance standards.
Providing regulatory compliance guidance and quality improvement advice to the Medical Oncology Department.
Reporting, managing and following deviations, complaints, issues, non-conformances and their related CAPAs.
Monitor risk management activities in clinical trials.
Prepare training materials and conduct trainings on relevant clinical trial quality assurance issues.
Guarantee ongoing compliance with quality and industry regulatory requirements.
Application:
About VHIO:
Under the leadership of Josep Tabernero, the Vall d’Hebron Institute of Oncology (VHIO), created by José Baselga in 2006, has established itself as a comprehensive cancer centre of proven excellence internationally. It is thanks to Josep´s directorship and VHIO´s optimal organisational structure based on a purely multidisciplinary and translational model that VHIO talents continue to anticipate and tackle the many unresolved questions in combatting this multifaceted and heterogeneous disease.
Located within the Vall d´Hebron Barcelona Hospital Campus, our researchers closely collaborate and interact with Vall d´Hebron physician-scientists. Translational science and clinical research are therefore tightly connected which promotes superb interaction and teamwork which, in turn, accelerates the bench-bedside-bed cycle of knowledge. This privileged environment affords VHIO direct access to patients as well as the entire spectrum of oncology professionals who care for them, and a second-to-none appreciation of how cancer science can translate into more powerful, targeted treatments and better practice for the care of patients.
VHIO´s pioneering model and programmes, coupled with its belief in combining strengths through cross-border collaborations, continue to spur advances in reversing cancer resistance, halting metastatic spread, and more effectively treating even the most undruggable tumour types.
VHIO´s translation toward precision oncology: https://www.vhio.net
