Clinical Research Associate

4 weeks ago

Oslo, Oslo County, Norway IQVIA Full time
{"Job Overview

As a Clinical Research Associate at IQVIA, you will play a critical role in ensuring the successful execution of clinical trials. Your primary responsibility will be to conduct site management and monitoring activities to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

**Key Responsibilities:**

* Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
* Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
* Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
* Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
* Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
* Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
* Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
* Collaborate and liaise with study team members for project execution support as appropriate.
* If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
* If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

**Requirements:**

* High School Diploma or equivalent Degree in scientific discipline or health care preferred.
* Equivalent combination of education, training and experience may be accepted in lieu of degree.
* Some organizations require completion of CRA training program or prior monitoring experience.
* Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
* Good therapeutic and protocol knowledge as provided in company training.
* Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
* Written and verbal communication skills - Must be fluent in English and Local language
* Organizational and problem-solving skills.
* Effective time and financial management skills.
* Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

**About IQVIA:**

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more

  • Clinical Research Associate

    1 week ago

    Oslo, Oslo County, Norway Pharmiweb Full time

    Job Title: Clinical Research AssociateWe are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team in Norway. As a Clinical Research Associate, you will be responsible for monitoring clinical sites, maintaining study files, conducting pre-study and initiation visits, and liaising with vendors.Key Responsibilities:Monitor...

  • Senior Clinical Research Associate

    2 weeks ago

    Oslo, Oslo County, Norway Pharmiweb Full time

    Job Title: Senior Clinical Research AssociateWe are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team in Norway. As a Senior Clinical Research Associate, you will be responsible for monitoring clinical sites, maintaining study files, conducting pre-study and initiation visits, and liaising with vendors.Key...

  • Clinical Research Associate

    4 weeks ago

    Oslo, Oslo County, Norway IQVIA Argentina Full time

    Job OverviewAs a Clinical Research Associate, you will play a crucial role in ensuring the successful execution of clinical trials. Your primary responsibility will be to conduct site management and monitoring visits to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and...

  • Experienced Clinical Research Associate

    1 month ago

    Oslo, Oslo County, Norway IQVIA Argentina Full time

    Job OverviewAs a Clinical Research Associate at IQVIA Argentina, you will play a critical role in ensuring the successful execution of clinical trials. Your primary responsibility will be to conduct site management and monitoring activities to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol,...

  • Senior Consultant

    4 weeks ago

    Oslo, Oslo County, Norway Department of Transplantation Medicine, Clinical effectiveness research group, O Full time

    {"h1": "Clinical Research Position in Gastroenterology", "p": "We are seeking a highly skilled and experienced Clinical Research Specialist to join our team at the Department of Transplantation Medicine, Clinical effectiveness research group, Oslo University Hospital. The successful candidate will lead a research project focused on clinical testing of new...

  • Associate Professor Position in Biostatistics and Epidemiology

    1 month ago

    Oslo, Oslo County, Norway The International Society for Bayesian Analysis Full time

    Associate Professor Position in Biostatistics and EpidemiologyWe are seeking a highly qualified Associate Professor to join our team at the Oslo Centre for Biostatistics and Epidemiology, University of Oslo, Norway.The successful candidate will have a strong track record in statistics, including biostatistics, mathematical statistics, data science, machine...

  • Senior Consultant and Adjunct Professor/Associate Professor in Medicine

    1 month ago

    Oslo, Oslo County, Norway Byggmakker Norge AS Full time

    About the PositionWe are seeking a highly skilled and experienced Senior Consultant and Adjunct Professor/Associate Professor in Medicine to join our team at Byggmakker Norge AS. As a key member of our organization, you will be responsible for providing expert medical guidance and leadership in the field of rheumatology.Key ResponsibilitiesProvide...

  • Senior Research Scientist

    2 weeks ago

    Oslo, Oslo County, Norway Work In Biotech Full time

    Senior Scientist - Radioligand TherapyWe are seeking a highly motivated Senior Scientist to join our Translational Biology team in Radiobiology. As a key member of our team, you will play a crucial role in advancing our innovative pipeline of targeted radiotherapies designed to revolutionize cancer treatment.ResponsibilitiesManage and execute in-vitro...

  • Senior Research Scientist

    2 days ago

    Oslo, Oslo County, Norway Work In Biotech Full time

    Senior Scientist - Radioligand TherapyWe are seeking a highly motivated Senior Scientist to join our Translational Biology team in Radiobiology. As a key member of our team, you will play a crucial role in advancing our innovative pipeline of targeted radiotherapies designed to revolutionize cancer treatment.ResponsibilitiesManage and execute in-vitro...

  • Associate Professor in Biostatistics and Epidemiology

    4 weeks ago

    Oslo, Oslo County, Norway The International Society for Bayesian Analysis Full time

    Opportunity for Academic ExcellenceWe are seeking a highly qualified Associate Professor to join our team at the Oslo Centre for Biostatistics and Epidemiology, University of Oslo, Norway.The successful candidate will have a strong track record in statistics, including biostatistics, mathematical statistics, data science, machine learning, or epidemiology,...

  • Senior Director of Clinical Imaging

    1 month ago

    Oslo, Oslo County, Norway ARTBIO Full time

    About the RoleWe are seeking a highly skilled Senior Director of Clinical Imaging to join our team at ARTBIO. As a critical member of our Program Team, you will play a key role in the development of our radioligand therapy (RLT) clinical development programs.Key ResponsibilitiesDevelop Clinical Imaging Strategies: Design and implement imaging protocols,...

  • Senior Research Scientist, In Vivo Biology

    1 month ago

    Oslo, Oslo County, Norway Work In Biotech Full time

    About UsAt Work In Biotech, we're a clinical-stage biopharmaceutical company pioneering a new class of alpha radioligand therapies (ARTs) to redefine cancer care. Our unique approach selects the optimal alpha-precursor isotope and tumor-specific targets to create therapeutics with the potential for highest efficacy and safety.We're advancing multiple...

  • Statistical Lead, Oncology, Clinical Trials

    1 month ago

    Oslo, Oslo County, Norway MAI Fortrea Development Limited Full time

    About the RoleWe are seeking a highly skilled Lead Statistical Programmer to join our team at MAI Fortrea Development Limited. As a key member of our team, you will be responsible for overseeing the programming activities on complex oncology projects, ensuring timely and high-quality delivery.Key ResponsibilitiesPlan, execute, and oversee all programming...

  • Biotech Research Technician

    1 month ago

    Oslo, Oslo County, Norway Work In Biotech Full time

    About UsAt Work In Biotech, we're a clinical-stage radiopharmaceutical company dedicated to revolutionizing cancer care through innovative alpha radioligand therapies. Our unique approach combines cutting-edge technology with a deep understanding of cancer biology to create therapeutics with unparalleled efficacy and safety.We're advancing multiple pipeline...

  • Senior Research Scientist, In Vivo Biology

    4 weeks ago

    Oslo, Oslo County, Norway ARTBIO Full time

    About the RoleWe are seeking a highly motivated and experienced Scientist/Senior Scientist to join our In Vivo Biology team at ARTBIO. As a key member of our team, you will play a crucial role in advancing our innovative pipeline of targeted radiotherapies designed to revolutionize cancer treatment.Key ResponsibilitiesDesign and execute research studies to...

  • Research Scientist, In Vivo Biology

    4 weeks ago

    Oslo, Oslo County, Norway ARTBIO Full time

    {"title": "Research Technician, In Vivo Biology", "description": "About the RoleWe are seeking a highly motivated and detail-oriented Research Technician to support our In Vivo Biology team. As a key member of our team, you will play a vital role in advancing our groundbreaking research efforts in targeted radioligand therapies.Key ResponsibilitiesPerform in...

  • Biotech Research Technician

    6 days ago

    Oslo, Oslo County, Norway Work In Biotech Full time

    About UsARTBIO is a pioneering clinical-stage radiopharmaceutical company revolutionizing cancer care by developing a new class of alpha radioligand therapies (ARTs). Our innovative approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for highest efficacy and safety. Our proprietary...

  • Laboratory Technician in In Vivo Research

    1 month ago

    Oslo, Oslo County, Norway Work In Biotech Full time

    About UsARTBIO is a pioneering clinical-stage radiopharmaceutical enterprise that is transforming cancer treatment through the development of innovative alpha radioligand therapies (ARTs). Our distinct approach focuses on selecting the most effective alpha-precursor isotope (212Pb) and specific tumor targets to formulate therapeutics aimed at maximizing both...

  • Postdoctoral Researcher in Computational Biology

    4 weeks ago

    Oslo, Oslo County, Norway Electrician Portsmouth Full time

    Postdoctoral Fellow in Computational BiologyWe are seeking a highly motivated Postdoctoral Fellow to join our team at the Centre for Molecular Medicine Norway (NCMM). The successful candidate will contribute to two projects focusing on prostate cancer research, funded by the Norwegian Cancer Society and the NCMM joint postdoctoral scheme.Key...

  • Postdoctoral Researcher in Organ-on-a-Chip Technology

    1 month ago

    Oslo, Oslo County, Norway D&A Services, Llc. Full time

    Job Opportunity: Postdoctoral Fellow in Organ-on-a-Chip SystemAbout the Role:We are seeking a highly motivated Postdoctoral Fellow to join our team at D&A Services, LLC. as a Postdoctoral Researcher in Organ-on-a-Chip Technology. The successful candidate will have the opportunity to work on a 3-year research project investigating bile duct inflammation using...