Experienced Clinical Research Associate

2 months ago

Oslo, Oslo County, Norway IQVIA Argentina Full time

Job Overview

As 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, applicable regulations and guidelines, and sponsor requirements.

Key Responsibilities

  1. Site Monitoring and Management
  • 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.
Training and Communication
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Quality Assurance and Control
  • 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.
Study Progress Management
  • 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.
Documentation and Record-Keeping
  • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
Reporting and Communication
  • 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.
Collaboration and Liaison
  • Collaborate and liaise with study team members for project execution support as appropriate.

Requirements

  1. Education and Experience
  • 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.
Skills and Knowledge
  • 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.

  • Clinical Research Associate

    4 weeks 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...

  • Clinical Research Associate Specialist

    4 days ago

    Oslo, Oslo County, Norway IQVIA Full time

    Job OverviewIQVIA seeks a Clinical Research Associate to perform monitoring and site management work 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.Responsibilities• Conduct site monitoring visits, including selection, initiation,...

  • Clinical Research Associate

    2 months ago

    Oslo, Oslo County, Norway IQVIA Full time

    {"Job OverviewAs 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...

  • Clinical Research Associate

    3 weeks ago

    Oslo, Oslo County, Norway IQVIA Full time

    Job OverviewAs 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 visits to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations...

  • Clinical Research Associate

    3 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 perform 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...

  • Clinical Research Associate

    2 months 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...

  • Senior Research Scientist

    1 month 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

    4 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...

  • Clinical Supply Chain Manager

    7 days ago

    Oslo, Oslo County, Norway IQVIA Full time

    Clinical Supply Chain Manager Job SummaryThe Clinical Supply Chain Manager will be responsible for managing the strategic planning and execution of clinical supply chain projects. This role will support the development and optimization of the Clinical Trial Supplies department and processes.Key ResponsibilitiesDevelop and implement effective clinical trial...

  • Biotech Research Technician

    4 weeks 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...

  • Associate Professor of Human Geography

    2 months ago

    Oslo, Oslo County, Norway Byggmakker Norge AS Full time

    Job Opportunity: Associate Professor of Human GeographyWe are seeking a highly qualified Associate Professor of Human Geography to join our team at the Department of Sociology and Human Geography. As a leading research institution in human geography, we are committed to excellence in research, teaching, and community engagement.About the PositionThe...

  • Biotech Research Technician

    3 weeks ago

    Oslo, Oslo County, Norway Work In Biotech Full time

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

  • Senior Radiobiology Expert

    4 days ago

    Oslo, Oslo County, Norway Work In Biotech Full time

    About the RoleWe are seeking a highly motivated Senior Scientist to join our Translational Biology team in Radioligand Therapy development. As a key member of our team, you will play a critical part in advancing our innovative pipeline of targeted radiotherapies designed to revolutionize cancer treatment.ResponsibilitiesManage and execute in-vitro...

  • Senior Scientist

    2 weeks ago

    Oslo, Oslo County, Norway Work In Biotech Full time

    Job SummaryWe are seeking a highly motivated Senior Scientist to join our Translational Biology team. 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 radiobiology studies to enable development of...

  • Professor / Associate Professor in Accounting or Auditing

    2 weeks ago

    Oslo, Oslo County, Norway BI Norwegian Business School Full time

    BI Norwegian Business School invites applications for a Professor / Associate Professor in Accounting or Auditing position at the Department of Accounting and Operations Management.The Department has 45 employees, with 40% being international, and covers education and research in financial accounting, auditing, financial management, management accounting,...

  • Postdoctoral Research Fellow in Finance

    4 weeks ago

    Oslo, Oslo County, Norway BI Norwegian Business School Full time

    Join Our Research TeamThe Department of Finance at BI Norwegian Business School invites applications for a postdoctoral research position with a focus on funding frictions after the global financial crisis. This position is part of the ERC project "Funding Frictions after the Global Financial Crisis" and offers a unique opportunity to work with a team of...

  • Research Trainee

    2 months ago

    Oslo, Oslo County, Norway DNV Full time

    About DNVDNV is a world-leading company that safeguards life, property, and the environment. Our purpose is to empower our customers to make informed decisions that minimize risk and maximize value.Job SummaryWe are seeking a highly motivated and talented Research Trainee to join our Group Research and Development team. As a Research Trainee, you will have...

  • Associate Professors of Human Geography

    2 weeks ago

    Oslo, Oslo County, Norway University of Oslo Full time

    We are seeking an Associate Professor in Human Geography to join our team at the Department of Sociology and Human Geography. The successful candidate will have a strong research profile and track record of publications in human geography, with a focus on urban and regional geography, including planning.The department is ranked as the premier academic...

  • Maritime Autonomy Research Student

    4 days ago

    Oslo, Oslo County, Norway DNV Full time

    Join Our Maritime Autonomy Research TeamWe are seeking highly motivated and talented students to participate in our research project on maritime autonomy at DNV. As a research assistant, you will work alongside our experienced team to develop and test autonomous navigation systems for ships. This is an excellent opportunity to gain valuable experience in...

  • Lead Statistical SAS Programmer, Oncology, Single Sponsor

    2 weeks ago

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

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.As a Lead Statistical...