Clinical Research Associate II
4 days ago
We are seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team. As a CRA II, you will be responsible for conducting site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
Key Responsibilities:- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
- Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions.
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
- Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
- Conduct Source Document Review of appropriate site source documents and medical records.
- Verify required clinical data entered in the case report form (CRF) is accurate and complete.
- Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary.
- Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
- Verify site compliance with electronic data capture requirements.
- May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
- Verify the IP has been dispensed and administered to subjects/patients according to the protocol.
- Verify issues or risks associated with blinded or randomized information related to IP.
- Apply knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released/returned.
- Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
- Reconcile contents of the ISF with the Trial Master File (TMF).
- Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
- Support subject/patient recruitment, retention, and awareness strategies.
- Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
- For assigned activities, understand project scope, budgets, and timelines; manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met.
- May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
- Ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.
- Participate in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project-specific requirements.
- Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required.
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Excellent communication, presentation, and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
-
Researcher Position
4 weeks ago
Bergen, Vestland, Norway Byggmakker Norge AS Full timeAbout the PositionWe are seeking a highly skilled Researcher to join our team at Western Norway University of Applied Sciences. The successful candidate will be working on the NOVO project, which aims to develop real-time dose verification technology for proton therapy-based cancer care.The Researcher will be responsible for developing image reconstruction...
-
Bergen, Vestland, Norway University of Bergen Full timeProject Overview: The research initiative is associated with the ATLAS experiment at CERN, conducted within the ATLAS team at the Department. The team is currently engaged in investigations for supersymmetry and other indicators of Dark Matter, alongside analyses of the CP characteristics of the Higgs boson. The focus is on final states that include multiple...
-
Associate Professor in History of Art
2 weeks ago
Bergen, Vestland, Norway University of Bergen Full timeAbout the PositionThe Faculty of Humanities at the University of Bergen invites applications for a permanent position as Associate Professor in History of Art at the Department of Linguistic, Literary and Aesthetic Studies (LLE).Key ResponsibilitiesConduct research in the field of History of Art and contribute to the development of the research...
-
Research Assistant
2 weeks ago
Bergen, Vestland, Norway University of Bergen Full timeJob Title: Predoctoral FellowWe are seeking a highly motivated and skilled Predoctoral Fellow to join our research team at the Centre for Research on Discretion and Paternalism (DIPA) at the Department of Government, University of Bergen, Norway.Job Description:The Predoctoral Fellow will assist academic staff in their instructional and research endeavors,...
-
Bergen, Vestland, Norway Society for Learning Analytics Research Full timeResearch Position in Artificial Intelligence and EducationWe are seeking a highly qualified researcher and educator to join our team at the Centre for the Science of Learning and Technology (SLATE). The successful candidate will contribute to our interdisciplinary research on artificial intelligence and education, with a focus on human-centered AI in...
-
Bergen, Vestland, Norway Society for Learning Analytics Research Full timeAbout the PositionWe are seeking a highly qualified and experienced academic leader to join our team at the Society for Learning Analytics Research. The successful candidate will be responsible for leading our research efforts in the area of artificial intelligence and education, with a focus on human-centered AI solutions.Key ResponsibilitiesConduct...
-
Bergen, Vestland, Norway University of Bergen Full timePosition Title: Research Associate in Political Science or Economics Institution: University of Bergen - Advancing Knowledge for Society The University of Bergen is dedicated to fostering a society enriched by knowledge, skills, and values through active engagement with global, national, and local communities. Role Overview: We are seeking a Research...
-
Associate Professor in History of Art
2 weeks ago
Bergen, Vestland, Norway University of Bergen Full timeAbout the PositionThe University of Bergen invites applications for a permanent position as Associate Professor in History of Art at the Department of Linguistic, Literary and Aesthetic Studies (LLE). The successful candidate will have the opportunity to contribute to the department's research and teaching in the field of art history.ResponsibilitiesConduct...
-
Postdoctoral Researcher in Marine Hydrodynamics
4 weeks ago
Bergen, Vestland, Norway Byggmakker Norge AS Full timePostdoctoral Researcher in Marine HydrodynamicsWe are seeking a highly motivated postdoctoral researcher to join our team at Western Norway University of Applied Sciences. The successful candidate will be part of the Wind, Water and Waves research group in the Department of Mechanical Engineering and Maritime Studies.The research project HYDROdynamic Mooring...
-
Postdoctoral Research Fellow in Formal Methods
4 weeks ago
Bergen, Vestland, Norway European Association for Programming Languages and Systems (EAPLS) Full timePostdoctoral Research Position in Formal Methods**About the Project**We are seeking a highly skilled postdoctoral researcher to join our team at the European Association for Programming Languages and Systems (EAPLS) in Bergen, Norway. The successful candidate will be part of the Norwegian Research Council Young Research Talents project CROFLOW, which aims to...
-
Bergen, Vestland, Norway University of Bergen Full timePosition Overview: The University of Bergen is inviting applications for a Research Associate in Political Science or Economics within the Department of Government. This is a full-time, temporary role aimed at fostering academic growth and research excellence. About the Role: The successful candidate will engage in significant research focusing on the...
-
Bergen, Vestland, Norway European Association for Programming Languages and Systems (EAPLS) Full timePostdoctoral Research Fellow in Formal Methods for Business Process Modelling**Job Summary**We are seeking a highly skilled Postdoctoral Research Fellow to join our team at the European Association for Programming Languages and Systems (EAPLS) in the field of Formal Methods for Business Process Modelling.**Key Responsibilities**Contribute to the development...
-
Bergen, Vestland, Norway MPOWIR Mentoring Physical Oceanography Women to Increase Retention Full timePostdoctoral Fellow in Climate ModellingWe are seeking a highly motivated and experienced postdoctoral researcher to join our team at the University of Bergen. The successful candidate will work on developing a higher resolution version of the Norwegian Earth System Model, focusing on the interaction between the North Atlantic, Nordic Seas, and Arctic.About...
-
Bergen, Vestland, Norway University of Bergen Full timePhD Researcher/Postdoctoral Position in Legal Studies (3 to 4 years) University of Bergen - Shaping Knowledge for Society At the University of Bergen, we engage in meaningful interactions with our surroundings—globally, nationally, and locally—to foster a society grounded in knowledge, skills, and values. Are you interested in contributing to the future...
-
Bergen, Vestland, Norway University of Bergen Full timeJob Opportunity at the University of BergenWe are seeking a highly qualified Research Fellow to join our team at the Department of Government. This is an excellent opportunity for a young scholar to contribute to a growing research literature on the legacies of war, conflict, and insecurity on societal, political, and economic outcomes.About the PositionThe...
-
Bergen, Vestland, Norway University of Bergen Full timeAbout the ProjectThe Corinth Rift system, Greece, is one of the best-documented rift systems on Earth, with high-resolution mapping of both onshore and offshore fault and basin structure. This PhD project aims to quantify and model the 3D response of active rift evolution to surface processes in the Corinth Rift system.Main ObjectivesUnderstand how...
-
Nurse Practitioner
1 month ago
Bergen, Vestland, Norway Florida Naturopathic Physicians Association Full timeAbout the RoleWe are seeking a highly skilled and compassionate Nurse Practitioner to join our team at Florida Naturopathic Physicians Association. As a Home Health Care Specialist, you will play a vital role in providing high-quality, patient-centered care to individuals in the comfort of their own homes.Key ResponsibilitiesConduct comprehensive in-home...
-
Bergen, Vestland, Norway Arkitekt Full timeTeaching Opportunities at Bergen School of ArchitectureBergen School of Architecture is pleased to announce several fixed-term teaching positions within Architecture, Landscape Architecture, Architectural Theory & Writing, and Visual Art.We are seeking experienced and dedicated teachers who are active practitioners with an exploratory approach. The positions...
-
Senior Geneticist
4 weeks ago
Bergen, Vestland, Norway ECO Magazine Full timeOcean Career: Benchmark Genetics Senior GeneticistBenchmark Genetics is a leading provider of genetically improved Atlantic salmon, Penaeus vannamei, and Genetic Services to the global aquaculture industry.The company operates state-of-the-art multitrait selection programs with nucleus operations in Europe and the Americas, and runs extensive research and...
-
Bergen, Vestland, Norway European Association for Architectural Education - KU Leuven Full timeTeaching Opportunities in Architecture and Related DisciplinesBergen School of Architecture is seeking experienced practitioners to fill several six-year fixed-term teaching positions within Architecture, Landscape Architecture, Architectural Theory & Writing, and Visual Art.We are looking for active professionals with an exploratory approach who are...
