Clinical Trial Coordinator
3 tygodni temu
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
Position Overview:As a Clinical Trial Coordinator, you will provide administrative and technical support to the Project Team. You will support audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document.
Essential Functions:- According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
- Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
- Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.
- Provides system support (i.e. GoBalto & eTMF).
- Supports RBM activities.
- Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
- Supports scheduling of client and/or internal meetings.
- Reviews and tracks local regulatory documents.
- Transmits documents to client and centralized IRB/IEC.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
- Maintains vendor trackers.
- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request.
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
- Bachelor's degree preferred.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities:- Ability to work in a team or independently as required
- Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Flexibility to reprioritize workload to meet changing project timelines
- Proven ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
- Good English language and grammar skills and proficient local language skills as needed
- Advanced digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
- Ability to successfully complete PPD clinical training program
- Self-motivated, positive attitude and good interpersonal skills
We hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
What we offer:As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply todayThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
-
Clinical Research Manager
2 tygodni temu
Warszawa, Mazovia, Polska MSD Pełny etatJob DescriptionThis position plays a key role in managing the performance and project execution of assigned protocols in a specific country while ensuring compliance with regulations and company standards.The Clinical Research Manager (CRM) may oversee studies across multiple countries within a cluster.Responsibilities include:Acting as the Main Point of...
-
Clinical Research Manager
4 tygodni temu
Warszawa, Mazovia, Polska MSD Pełny etatJob DescriptionThis position plays a key role in managing the performance and project execution of assigned protocols in a specific country while ensuring compliance with regulations and company standards.The Clinical Research Manager (CRM) may oversee studies across multiple countries within a cluster.Responsibilities include:Acting as the Main Point of...
-
Clinical Research Manager
2 tygodni temu
Warszawa, Mazovia, Polska MSD Pełny etatJob DescriptionThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.The CRM could be responsible for a...
-
Clinical Research Manager
1 tydzień temu
Warszawa, Mazovia, Polska MSD Pełny etatJob DescriptionThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a...
-
Clinical Research Associate
3 tygodni temu
Warszawa, Mazovia, Polska MSD Pełny etatJob Requirements This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.If you want to: Join a multi-award-winning...
-
Clinical Research Associate
2 tygodni temu
Warszawa, Mazovia, Polska MSD Pełny etatJob Requirements This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.If you want to: Join a multi-award-winning...
-
Associate Clinical Research Associate
2 tygodni temu
Warszawa, Mazovia, Polska MSD Pełny etatJob DescriptionIf you want to: Join a multi-award-winning leading biopharmaceutical company Be part of growing team of Clinical Research Associates Use new technology and smart monitoring tools Have flexibility of work and good work-life balance Apply today On this position you will be accountable for performance and compliance for assigned protocols and...
-
Associate Clinical Research Associate
2 tygodni temu
Warszawa, Mazovia, Polska MSD Pełny etatJob DescriptionIf you want to: Join a multi-award-winning leading biopharmaceutical company Be part of growing team of Clinical Research Associates Use new technology and smart monitoring tools Have flexibility of work and good work-life balance Apply today On this position you will be accountable for performance and compliance for assigned protocols and...
-
Site Contract Manager
2 miesięcy temu
Warszawa, Mazovia, Polska Johnson & Johnson Pełny etatSite Contract Manager Location: Poland Full time job Responsible for preparing, negotiating, and finalizing agreements and budgets related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of...
-
Senior Project Quality and Risk Lead
2 tygodni temu
Warszawa, Mazovia, Polska Parexel Pełny etatWe are currently looking for experienced Project Quality and Risk Leads with expertise with ICH-GxP principles and clinical trial regulations to be based in Poland or Lithuania or Romania or Hungary.As the Senior Project Quality and Risk Lead you will actively act as Risk Manager, being responsible to coordinate Critical to Quality (CtQ) identification,...
-
Senior Project Quality and Risk Lead
3 tygodni temu
Warszawa, Mazovia, Polska Parexel Pełny etatWe are currently looking for experienced Project Quality and Risk Leads with expertise with ICH-GxP principles and clinical trial regulations to be based in Poland or Lithuania or Romania or Hungary.As the Senior Project Quality and Risk Lead you will actively act as Risk Manager, being responsible to coordinate Critical to Quality (CtQ) identification,...
-
External Reporting Statutory Accountant
2 tygodni temu
Warszawa, Mazovia, Polska Thermo Fisher Scientific Pełny etatJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step...
-
External Reporting Statutory Accountant
3 tygodni temu
Warszawa, Mazovia, Polska Thermo Fisher Scientific Pełny etatJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step...
-
Senior WPE Manager
2 tygodni temu
Warszawa, Mazovia, Polska International Rescue Committee (IRC) Pełny etatJOB DESCRIPTIONIRC Poland: On 8 February 2022 three IRC staff arrived in Poland to initiate scoping of local and national actors in Warsaw, Lublin, and Rzeszow as well as across the Western, Central, and Eastern regions in Ukraine. When on 24 February Russian troops entered eastern Ukraine with the aim of toppling the government led by President Volodymyr...
-
Senior WPE Manager
2 tygodni temu
Warszawa, Mazovia, Polska International Rescue Committee (IRC) Pełny etatJOB DESCRIPTIONIRC Poland: On 8 February 2022 three IRC staff arrived in Poland to initiate scoping of local and national actors in Warsaw, Lublin, and Rzeszow as well as across the Western, Central, and Eastern regions in Ukraine. When on 24 February Russian troops entered eastern Ukraine with the aim of toppling the government led by President Volodymyr...
-
Senior WPE Manager
3 tygodni temu
Warszawa, Mazovia, Polska International Rescue Committee (IRC) Pełny etatJOB DESCRIPTIONIRC Poland: On 8 February 2022 three IRC staff arrived in Poland to initiate scoping of local and national actors in Warsaw, Lublin, and Rzeszow as well as across the Western, Central, and Eastern regions in Ukraine. When on 24 February Russian troops entered eastern Ukraine with the aim of toppling the government led by President Volodymyr...
-
Senior WPE Manager
3 tygodni temu
Warszawa, Mazovia, Polska International Rescue Committee (IRC) Pełny etatJOB DESCRIPTIONIRC Poland: On 8 February 2022 three IRC staff arrived in Poland to initiate scoping of local and national actors in Warsaw, Lublin, and Rzeszow as well as across the Western, Central, and Eastern regions in Ukraine. When on 24 February Russian troops entered eastern Ukraine with the aim of toppling the government led by President Volodymyr...
-
Regulatory Clinical Trial Application Submission Manager
2 miesięcy temu
Warszawa, Polska ManpowerGroup Sp. z o.o. Pełny etatManpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i...
-
Regulatory Clinical Trial Application Submission Manager
2 tygodni temu
Warszawa, Polska ManpowerGroup Sp. z o.o. Pełny etatManpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i...
-
Senior Project Quality and Risk Lead
3 tygodni temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. We are currently looking for experienced Project Quality and Risk Leads with expertise with ICH-GxP principles and clinical trial regulations to be based in Romania or Poland or Lithuania or Hungary or Spain or Turkey . As the Senior Project Quality and Risk Lead you will...
-
Senior Project Quality and Risk Lead
3 tygodni temu
Warszawa, Polska Parexel Pełny etatWe are currently looking for experienced Project Quality and Risk Leads with expertise with ICH-GxP principles and clinical trial regulations to be based in Poland or Lithuania or Romania or Hungary.As the Senior Project Quality and Risk Lead you will actively act as Risk Manager, being responsible to coordinate Critical to Quality (CtQ) identification,...
-
Senior Project Quality and Risk Lead
2 tygodni temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. We are currently looking for experienced Project Quality and Risk Leads with expertise with ICH-GxP principles and clinical trial regulations to be based in Romania or Poland or Lithuania or Hungary or Spain or Turkey . As the Senior Project Quality and Risk Lead you will...
-
Regulatory Scientist
3 tygodni temu
Warszawa, Polska ManpowerGroup Sp. z o.o. Pełny etatManpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i...
-
Regulatory Scientist
2 tygodni temu
Warszawa, Polska ManpowerGroup Sp. z o.o. Pełny etatManpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i...
-
Senior Regulatory Affairs Associate
2 miesięcy temu
Warszawa, Polska Parexel Pełny etatWhen our values align, there's no limit to what we can achieve. We are excited to announce an opportunity for a skilled and experienced Senior Regulatory Affairs Associate to join our dynamic and expanding team at Parexel. This role can be either home or office-based in Croatia, Romania, Poland, Lithuania, Czechia, Serbia and Hungary. As the Senior...
-
Senior Regulatory Specialist, CTA/IND
4 dni temu
Warszawa, Polska 9605 GSK Services Sp z o.o. Pełny etatWe are now looking for a SENIOR REGULATORY SPECIALIST ( CTA/ IND) to join our Polish Hub. Key Responsibilities: Coordination, development, refinement of the CTA/IND lifecycle strategy, timely content & delivery appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures. Accountable to the functional...
