Cra (Level I)
Il y a 3 mois
**CRA (Level I) - Paris, Lyon, Nantes, Marseille, Bordeaux - Office or Home based**
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.
**Location/Division Specific Information**:
Our clinical department defines, develops and delivers clinical programmes. 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 implement high-quality, cost-efficient clinical studies.
**Discover Impactful Work**:
- Performs and coordinates all aspects of the clinical monitoring and site management process.
- Conducts remote or on-site visits to assess protocol and regulatory compliance and handles required documentation.
- Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
- Ensures audit readiness.
- Develops collaborative relationships with investigational sites.
- Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
**A day in the Life**:
- Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Assess investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Brings up observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
- May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
- Conducts monitoring tasks in accordance with the approved monitoring plan.
- Participates in the investigator payment process.
- Ensures a shared responsibility with other project team members on issues/findings resolution.
- Investigates and follows-up on findings as applicable
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
- Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS).
- Performs QC check of reports generated from CTMS system where required.
- Participates in investigator meetings as necessary.
- Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Gives to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral, and/or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections.
- Maintains & completes administrative tasks, such as expense reports and timesheets in a timely manner.
- Gives to other project work and initiatives for process improvement, as required
**Education**
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Pre
-
Cra (Level Ii) - Marseille - Home-based
Il y a 2 mois
Ivry-sur-Seine, France Thermo Fisher Scientific Temps pleinJob Description **CRA (Level II) - Paris, Lyon, Nantes, Marseille, Bordeaux - Office or Home based** 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...
-
Cra (Level Ii) - Bordeaux - Home-based
Il y a 2 mois
Ivry-sur-Seine, France Thermo Fisher Scientific Temps plein**CRA (Level II) - Paris, Lyon, Nantes, Marseille, Bordeaux - Office or Home based** 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...
-
Cra (Level Ii) - Nantes - Home-based
Il y a 3 mois
Ivry-sur-Seine, France Thermo Fisher Scientific Temps pleinJob Description **CRA (Level II) - Paris, Lyon, Nantes - Office or Home based** 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...
-
Cra (Level Ii) - Lyon - Home-based
Il y a 3 mois
Ivry-sur-Seine, France Thermo Fisher Scientific Temps plein**CRA (Level II) - Paris, Lyon - Office or Home based** 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...
-
Cra (Level Ii) - Paris - Home-based
Il y a 3 mois
Ivry-sur-Seine, France Thermo Fisher Scientific Temps pleinJob Description **CRA (Level II) - Paris, Lyon - Office or Home based** 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...
-
Cra
Il y a 2 mois
Ivry-sur-Seine, France Thermo Fisher Scientific Temps plein**CRA (Level II) - Paris, Lyon, Nantes, Marseille, Bordeaux - Office or Home based** 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...
-
Cra
Il y a 2 mois
Ivry-sur-Seine, France Thermo Fisher Scientific Temps pleinJob Description**CRA (Level II) - Paris, Lyon, Nantes, Marseille, Bordeaux - Office or Home based** 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...
-
Cra
Il y a 2 mois
Ivry-sur-Seine, France Thermo Fisher Scientific Temps pleinOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...
-
Assistant Cra
Il y a 3 mois
Ivry-sur-Seine, France Thermo Fisher Scientific Temps pleinAt 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...
-
Assistant Cra
Il y a 3 mois
Ivry-sur-Seine, France Thermo Fisher Scientific Temps pleinAt 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...
-
Financial Project Controller I&C VVER F/H
il y a 3 semaines
Neuilly-sur-Seine, Île-de-France Framatome Temps pleinMission Overview Reporting directly to the financial controller of the I&C Business Unit in France, and closely collaborating with the Senior Project Manager and Project Managers, the individual will play a crucial role as a business partner to the I&C project leaders, contributing to the promotion of a performance-driven culture. The role may also...
-
Eu R&i Packaging Manager
Il y a 3 mois
Gif-sur-Yvette, France Danone Temps pleinAbout the job Positioning in the organization: - Department: Within the Europe Zone department, in the ONE PACKAGING team - Reporting to: Packaging Hub South Europe Background, Department challenges: The main missions of the Europe zone are to: - Enable the rapid development of the business through the realization of ambitious and profitable innovation...
-
Clinical Research Associate in Oncology
il y a 3 semaines
Neuilly-sur-Seine, Île-de-France Ividata Life Sciences Temps pleinIvidata Life Sciences is a prominent entity within the Ividata group, dedicated to assisting professionals in the healthcare sector across France since 2013. Our expertise spans various domains including clinical operations, biostatistics, data analytics, pharmacovigilance, regulatory compliance, and quality management. We strive to innovate, foresee...
-
Country Approval Specialist
Il y a 3 mois
Ivry-sur-Seine, France Thermo Fisher Scientific Temps pleinAt 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...
-
Country Approval Specialist
Il y a 3 mois
Ivry-sur-Seine, France Thermo Fisher Scientific Temps pleinAt 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...
-
Hindi home tutor
il y a 1 semaine
Argelès-sur-Mer, France TeacherOn.com Temps partielHello sir I have a question I have a friend who is Indian origin and lives in rishikesh he doesn’t read or write in Hindi and I would like to give him a present and give him the possibility to learn and I will pay for this, so he has two to three lead sons a week. In person is this something you offer? Thank you for your time. LinditaLevel: Beginner...
-
Cdi - Global Diversity, Equity & Inclusion Director
Il y a 3 mois
Neuilly-sur-Seine, France Sephora Temps pleinazeee At Sephora, we reimagine beauty, discover new brands, and influence positive change every day. Get ready to think creatively, work strategically, and make your mark at a leading global retailer. Together, we’re evolving, innovating, and reimagining the future of beauty and retail. You will develop and implement our global D,E&I strategy and...
-
Cdi - Global Diversity, Equity & Inclusion Director
Il y a 3 mois
Neuilly-sur-Seine, France Sephora Temps pleinazeee At Sephora, we reimagine beauty, discover new brands, and influence positive change every day. Get ready to think creatively, work strategically, and make your mark at a leading global retailer. Together, we’re evolving, innovating, and reimagining the future of beauty and retail. You will develop and implement our global D,E&I strategy and...
-
Assistant de Direction in Digital Transformation
il y a 2 semaines
Morsang-sur-Orge, Île-de-France iscod alternance Temps pleinShape the Future of Learning with ISCODWe are seeking a highly motivated and organized individual to join our partner company, a leading force in digital transformation, as an Assistant de Direction. This apprenticeship opportunity will provide you with invaluable experience and prepare you for our state-recognized diploma courses ranging from level 5 to...
-
Apprenticeship Executive Assistant
il y a 3 semaines
Morsang-sur-Orge, Île-de-France iscod alternance Temps pleinJoin ISCOD and embark on a journey into the realm of digital education. We are seeking a dedicated Executive Assistant for an apprenticeship role, aimed at preparing you for our accredited diploma programs ranging from level 5 to level 7 (Equivalent to Bac+2, Bachelor/Bac+3, and Mastère/Bac+5).Embrace the future of apprenticeship with ISCODKey...