The Clinical Trials Management Unit is responsible for overseeing the operational activities of the commercial clinical studies at the Vall d'Hebron Campus.
The primary objective of this Unit is to support clinicians and Principal Investigator of Vall d'Hebron Campus in conducting their clinical studies in accordance with each protocol, while adhering to GCP and current regulations.
Over the past year, the number and complexity of clinical trials at Vall d'Hebron University Hospital have significantly increased, contributing to improve life expectancy for our patients.
This growth demands a well-organized, methodical, and people-oriented individual who is eager to develop a career in this field.
The Clinical Trials Management Unit is seeking to fill one position for a Senior Study Coordinator.
This call will focus on clinical trials within the Chronicity and Neurosciences area of knowledge.
Education and qualifications: Required: Master's degree in Clinical Trials Specialist in administrative management of Clinical Trials (CTA) Bachelor's Degree in Health Sciences preferable but open to other related disciplines Actic level 3 (computer and office program skills) Fluency in Catalan, Spanish, English (business level) Desired: Certification in Project Manager and Data Analysis Training in Good Clinical Practice (GCP) and clinical trials methodology Experience and knowledge: Required: More than 3 years of experience as Study Coordinator Knowledge of database program Ability to work independently as well as in a team environment Good communication skills and fluency in written and spoken English Desired: Experience with SAP management program Organized and methodical person with high motivation and initiative Quick response to time requested by the team and sponsor Main responsibilities and duties: Clinical Trial oversight and coordination: Ensure all Clinical trial activities adhere to the study protocol, Good Clinical Practice (GCPs), and regulatory requirements (protocol execution), oversee patient recruitment strategies and retention plans to meet enrolment goals (patient recruitment and retention), monitor compliance with the study timeline, deliverables and ethical guidelines (study compliance), address and resolve any operational challenges that arise during the trial (problem solving).
Team leadership and mentorship: Mentor junior study coordinators, data entry staff, and other team members involved in the clinical trials (team supervision), provide training on protocols, GCP, and institutional policies (teaching, training and development).
Communication and Liaison: Work closely with principal investigator (PIs) to ensure trials are conducted smoothly and effectively (coordination with investigator), ensure consistent communication between sponsors, investigators and the research team (stakeholder communication).
Regulatory and documentation Management: Ensure compliance with all applicable laws, regulations, and institutional policies (regulatory compliance), oversee the maintenance of regulatory documents, site files, and patient records (document management), prepare for and participate in audits or inspections by sponsors or regulatory authorities (audit readiness).
Study planning and logistic: Coordinate and scheduled study visits, ensuring all pre-visit requirements are met (scheduling and planning), supervise the accurate collection, handling, and recording of study data and biological samples.
Quality assurance: Verify all study data is accurate, complete, and entered into relevant systems promptly (data accuracy), ensure all documentation and records adhere to ALCOA+ principles, coordinate and support with on-site and remote monitoring visits and implement corrective actions as needed.
Budget and financial management: Collaborate with the finance team to track trial budgets and expenses, monitoring invoicing and payments to ensure proper reimbursement for study activities.
Innovation and process improvement: Identify areas for process improvement and implement changes to enhance efficiency and compliance (process optimization), leverage clinical trial management systems (CTMS) and other tools to streamline operations and reporting.
Labour conditions: Full-time position: 40h/week Starting date: Immediate Gross annual salary: Salary ranges are consistent with our Collective Agreement pay scale.
Contract: Linked to project (2 years approximately).
There are 2 positions for this vacancy.
There are two positions available for this vacancy.
What can we offer?
Incorporation to Vall d'Hebron Research Institute (VHIR), a public sector institution that promotes and develops the biomedical research, innovation and teaching at Vall d'Hebron University Hospital (HUVH), the biggest hospital of Barcelona and the largest of Catalan Institute of Health (ICS).
A scientific environment of excellence, highly dynamic, where high-end biomedical projects are continuously developed.
Continuous learning and a wide range of responsibilities within a stimulating work environment.
Individual training opportunities.
Flexible working hours.
23 days of holidays + 9 personal days.
Flexible Remuneration Program (including dining checks, health insurance, transportation and more) Corporate Benefits: platform through which you can obtain significant discounts on travel, culture, technology, gastronomy, sports... among many others.
Healthy Offering: choose from a variety of wellbeing focused activities to be the healthiest you.
Deadline to apply: 22-12-2024 VHIR embraces Equality and Diversity.
As reflected in our values we work toward ensuring inclusion and equal opportunity in recruitment, hiring, training, and management for all staff within the organization, regardless of gender, civil status, family status, sexual orientation, gender identity and expression, religion, age, functional diversity or ethnicity.