CRA Contractor (Sweden/ Norway) in PharmiWebJobs Global Life Science Jobs Andorra

Internship
  • Internship
  • Andorra

Website PharmiWebJobs Global Life Science Jobs

This job listing is about PharmiWebJobs Global Life Science Jobs in Andorra 2022 exclusively on jobizille.com

Proclinical are recruiting a CRA Contractor for a global CRO. This role is on a contract basis with the ability to work remotely. Travel across both Sweden and Norway is required.

Job Responsibilities

  • Complete site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
  • Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
    • Assesses site processes
    • Conducts Source Document Review of appropriate site source documents and medical records
    • Verifies required clinical data entered in the case report form (CRF) is accurate and complete
    • Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
    • Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
    • Verifies site compliance with electronic data capture requirements
  • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and releasedeturned.
  • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
  • Documents 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. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
  • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
  • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
  • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
  • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
  • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.

Skills And Requirements

  • 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 in Finland
  • Previous monitoring experience
  • Fluency in Finnish and proficient in English
  • Ability to manage the required travel, the sites are mainly based in Finland, some cross-border monitoring is possible

If you are having difficulty in applying or if you have any questions, please contact Carl Sundell at +41 61 508 70 52.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#Clinical

Company: PharmiWebJobs Global Life Science Jobs

Vacancy Type: Full Time 

Job Location:  Andorra

Application Deadline: N/A

Apply Here

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