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Ostatnia aktualizacja: ponad 30 dni temu
Clinical Research Associate (CRA) - Client-dedicated

Clinical Research Associate (CRA) - Client-dedicated

Thermo Fisher ScientificPoland
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 / ...Pokaż więcejOstatnia aktualizacja: ponad 30 dni temu
Senior Software Engineer (Service Infrastructure)

Senior Software Engineer (Service Infrastructure)

Affirm, Inc.Poland
Affirm is reinventing credit to make it more honest and friendly, giving consumers the flexibility to buy now and pay later without any hidden fees or compounding interest.This is a mission critica...Pokaż więcejOstatnia aktualizacja: ponad 30 dni temu
Middle Business Analyst

Middle Business Analyst

instinctoolsPoland
Pokaż więcejOstatnia aktualizacja: ponad 30 dni temu
Lead React Developer

Lead React Developer

Cavendish ProfessionalsPoland
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SAP Fiori / UI5 Developer (m / f / d)

SAP Fiori / UI5 Developer (m / f / d)

SWISS KRONO GroupPoland, Group Home Based
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SAP Fiori / UI5 Developer (m / f / d).The SWISS KRONO Group is one of the world's leading manufacturers of wood-based materials and stands for sustainable and innovative solutions in the fields of interi...Pokaż więcejOstatnia aktualizacja: ponad 30 dni temu
DevOps Engineer with Azure

DevOps Engineer with Azure

NATEKRemote, Poland
Our client is in the middle of a digital transformation, as are the industries we operate in.As part of an initiative to accelerate this process, we will build and scale infrastructure competence t...Pokaż więcejOstatnia aktualizacja: ponad 30 dni temu
DevOps Technical Leader (Azure, Security)

DevOps Technical Leader (Azure, Security)

SoftServePoland
SoftServe is a team of thinkers and doers, true professionals, and good people, solving business challenges with innovative technology solutions. You can meet SoftServians everywhere from the to Sin...Pokaż więcejOstatnia aktualizacja: ponad 30 dni temu
Specjalista ds. zakupów (Przeszkoda - gmina Żabia Wola)

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Payroll Delivery Specialist

AlightPoland
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Starszy Asystent / Asystent w Branży Sieć Trakcyjna M / F

Starszy Asystent / Asystent w Branży Sieć Trakcyjna M / F

EgisPoland
Egis is an international player active in the consulting, construction engineering and mobility service sectors.We design and operate intelligent infrastructure and buildings capable of responding ...Pokaż więcejOstatnia aktualizacja: ponad 30 dni temu
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Payroll Tax Expert - Germany

RemotePoland
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User Experience Researcher

User Experience Researcher

CollibraRemote, Poland
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Game Design Director - The Sims 4

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Team Manager

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AloricaPoland
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Nurse, Boleslawiec

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EuroclearPoland
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Project ManagerPoland, KrakowManagement Positions.

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Program Manager - R&D Engineering

Program Manager - R&D Engineering

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Neurosurgery Sales and Marketing Manager Eastern Europe and Middle East. Warsaw based

Neurosurgery Sales and Marketing Manager Eastern Europe and Middle East. Warsaw based

Chronos ConsultingPolska
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Ta oferta pracy nie jest dostępna w Twoim kraju.
Clinical Research Associate (CRA) - Client-dedicated

Clinical Research Associate (CRA) - Client-dedicated

Thermo Fisher ScientificPoland
Ponad 30 dni temu
Opis pracy
  • 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 using approved business writing standards. Raises 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 follow-up on findings as applicable. Participates in investigator meetings as vital. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs 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.
  • Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions ( Clinical Trial Management System).
  • Facilitates effective communication between investigative sites, client company and internal project teams through written, oral and / or electronic contacts. Responds to company, client and applicable regulatory requirements / audits / inspections.
  • Maintains and completes administrative tasks such as expense reports and timesheets in an accurate and timely manner.
  • Contributes to the project team by assisting in preparation of project publications / tools and sharing ideas / suggestions with team members.
  • Contributes to other project work and initiatives for process improvement, as required.
  • Education :

    • Bachelor's degree in a life sciences field.
    • At least 12 to 18 months of experience of independent, on-site monitoring in a Pharmaceutical or Clinical Research Organisation.
    • Experience in clinical trials, medical terminology, medical research, clinical research, health care or in a health sciences field.
    • Valid driver's license where applicable.
    • Knowledge, Skills & Abilities :

    • Oncology or Haemato-oncology experience highly preferable.
    • Basic medical / therapeutic area knowledge and understanding of medical terminology.
    • Ability to attain and maintain a proven understanding of ICH GCPs and industry regulations and procedural documents.
    • Good oral and written communication skills, with ability to communicate effectively with medical personnel.
    • Good interpersonal skills.
    • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
    • Good organizational and time management skills.
    • Ability to remain flexible and adaptable in a wide range of scenarios.
    • Well-developed critical thinking skills, including but not limited to : critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
    • Ability to manage Risk Based Monitoring concepts and processes.
    • Ability to work in a team or independently as required.
    • Good digital literacy : proven knowledge of Microsoft Office and ability to learn appropriate software.
    • Good English language and grammar skills.
    • Why join us?

      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 at you will benefit from an , 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 , where we 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.