Clinical Research Associate (Europe)

Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the CRA conducts clinical trial site start…… To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of…… Monitor on-site and remotely clinical trials in accordance with TFS and/or client company.
Set up ISF and SMF (or cooperate with CTA) and distribute to the…… Responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study initiation visits, regular visits and close out visits, assists…… Anchored in our company's scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is…… Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to…… Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International…… Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice and International Conference on…… The CTA is responsible for organizing and maintaining the Study Master File (SMF) and coordinating practical tasks during the study according to company…… The Associate supports client engagements and internal project team requests and policy projects by developing research plans; conducting research; collecting…… Validates study designs, is accountable for, and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial…… Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.… COM is the department that manages clinical trials at the country level: identification and selection of sites, submission of dossiers for approval, start-up…… AstraZeneca is an innovation-driven global biopharmaceutical company focused on the discovery, development and commercialization of prescription medicines,…… By assisting in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST)…… Support and act as the point of reference for Analysts in their daily activities and training, among others.
Associate Consultants are involved in the execution…… The Clinical Study Excellence Scientist (CSES) is the point of contact and responsibility for all aspects of a trial within the study team, with the aim of…… As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video,…… The SCA ensures that contracts meet needs of both clients and clinical trial sites, protecting best interests of clients and the company (as applicable), while…… The Associate Director is responsible to ensure that outcomes and quality data are produced to ensure the scientific medical standing of the potential value and…… They are also accountable for protocol registry and results eligibility assessment and must demonstrate capability to interpret, discuss and ensure appropriate…… Accountable for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation, for the…… At least 10-12 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment with at least 7 years of in-depth experience in clinical…… In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO…… You will be asked to travel at least 60% of the time (international and domestic -fly and drive) and should possess a valid driving license.… Schedules meetings and conference calls, domestic and international, with sensitivity and awareness of the urgency of such scheduling for the CEO or President.… Provide structure, develop guidance and establish best practices in partnership with regions and countries for train the trainer approach for product/disease…… Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
With access to the latest tools, information and training, we'll help you in advancing your skills and career.
Here, you'll be supported in progressing – whatever your ambitions.
About the Role The Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Centre of Excellence, conducting activities consistent with GCO's mission of building a world class shared clinical technology, process innovation and clinical operations team, in partnership with the company's divisions, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection.
Driving principles and behaviours for this role are collaboration, accountability, innovation, adaptability, integrity and caring.
Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the CRA conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures.
Specifically, these activities will include: Ethics Committee (EC) submissions and approvals.
Site informed consent form (ICF) customizations & negotiations.
Essential regulatory document collection.
Collaboration with Regulatory Affairs for Competent Authority (CA) submissions and approvals and other site start-up support activities, as applicable.
The CRA also provides support in enrolment, follow-up, and closure of clinical trial activities.
This role offers weekly hybrid working and can be based from any BSC hub location across Europe.
Your responsibilities will include: Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites.
Manage multiple sets of essential regulatory documents across several studies and division portfolios.
Partner with clinical sites to support the negotiation and customization of Informed Consent Forms (ICF).
Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies.
Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives.
Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking.
Manage and problem solve site start up challenges that arise to mitigate impact to service level agreement and study goals.
Develop, prepare, complete and track required regulatory, ICF and legal documentation.
Document clinical research site and investigator readiness for participation across multiple studies.
Support internal quality audits, regulatory inspections, as applicable.
Update and maintain study-specific startup and close out trackers.
Update and maintain site specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs.
Provide updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc.
Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinator, divisional clinical study leads and/or other stakeholders when appropriate.
Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.)
and internal SOPs/WI, policies & procedures.
What are we looking for in you: Successfully completed degree studies (or equivalent) within a relevant scientific or healthcare subject.
Fluent language skills (both verbal and written) in English and German.
Additional languages are beneficial.
Previous experience within Clinical Research is beneficial, such as: Study submissions to the Ethics Committee.
Experience as a Research Coordinator, In-House CRA, CRA, or Study Start-Up Specialist.
Experience with Clinical Trial Management systems (e.g., Siebel CTMS, Veeva, etc.)
and clinical document control systems / eTMF.
Strong communication skills and comfortable interacting with clinical research site personnel via phone, email, and in-person.
Can understand and communicate complex technical and clinical details through presentations.
Strong team player, collaborative, and can build relationships and work cross-functionally.
Can multitask, supporting several studies and/or personnel simultaneously, whilst working in a dynamic fast paced environment.
Comfortable with weekly hybrid working.
What we can offer to you: Experience in a groundbreaking multinational company with attractive benefits.
Upskilling.
A company with a purposeful mission.
Requisition ID: 591537 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life.
Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal.
And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
Job Segment: Clinical Research, Medical Research, Compliance, Document Control, Healthcare, Legal, Research, Administrative 1979 Tipo Empresa privada (cotiza en bolsa) Sector Fabricación de productos sanitarios Manufactura Ingresos Más de 10 000 millones (USD) 4,1 3,9 3,8 4,2 3,8 3,9 Ventajas "good people to work with" ( en 48 opiniones ) "Decent pay, rewarding job, and the company operates with high level of integrity."
( en 39 opiniones ) "Benefits are good."
( en 27 opiniones ) "Great work life balance" ( en 30 opiniones ) "The company culture is great" ( en 37 opiniones ) "Pay could be better and promoting" ( en 39 opiniones ) "Difficult work/ life balance as a clinical representative" ( en 30 opiniones ) "Fortunately, the company culture is such that when you do this, you will be heard, and you will be empowered to continue."
( en 37 opiniones ) 4,0 We recognize that good health, financial wellness and security are all critical to a productive workforce and support an ongoing culture of health.
Boston Scientific provides comprehensive benefit offerings to its employees supporting individual wellbeing needs and interests.
5 sept 2024 #J-18808-Ljbffr