Clinical Research Associate (CRA)

[Cordellia]

Noen som jobber som dette eller har erfaring fra feltet? Ser det er en del stillinger på Linkedin hvor man må ha tidligere erfaring. Har ikke hørt så mye om dette før og finner mest utenlandske sider når jeg googler. Slik jeg forstår det må man ha helsebakgrunn på minimum bachelornivå i tillegg til CRA-erfaring. Hvordan får man det?

[AnonymBruker]

Høres ut som klinisk forskningsassistent, da er det vanlig å ha master på toppen av en helsefaglig utdanning. Har ikke vært borti at man må ha noen form for sertifisering før søknad i Norge. Forskningssykepleier kan være et annet ord for det. Det er mange som bidrar rundt den kliniske forskningen som foregår på sykehusene.

Anonymkode: 4f24a...ac0

[Cordellia]

Hm. Stillingene jeg har sett ligner ikke på de typiske forskningssykepleier som er ute med jevne mellomrom? Forskningssykepleier er ofte i tilknytning til sykehus og prosjekter som foregår der. Mulig forskningsassistent er noe annet? 

 

Tekst fra en av annonsene (ekstern stilling): 

 

Main tasks and responsibilities:

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.

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) and 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.

Act as a mentor for clinical staff including conducting co-monitoring and training visits.

Qualifications

Must have a Bachelor's Degree in scientific discipline or health care.

At least 2 years of independent on-site monitoring experience.

Endret 14. mars 2023 av Cordellia