Freelance Snr. Clinical Research Associate, Norway

Job title : Freelance Snr. Clinical Research Associate, Norway
Location : Osloß
Job type : Contract/Freelance
Salary : €0.01 - €1.01 per annum
Contact name : Camille Sandres
Contact number : +44 (0) 207 255 6620
Contact email : camille.sandres@secpharma.com
Key information:

Start date: immediate
FTE: 0.8 (please note that the client can consider two CRAs)
Experience required: Oncology, Start-up (regulatory submission in Norway, Contract & Budget negotiation), Monitoring, Native level in Norwegian
Length: long term assignement

Main requirement:

(1) Ensure compliance with regulatory requirements and appropriate guidance,
(2) Assist in preparation of Clinical Site Agreements, including negotiation of site budgets;
(3) Participates in conducting investigator meetings, including advance preparation, presentations, problem resolution, and follow-up;
(4) Prepare and track study documentations throughout the life cycle of studies,
(5) Manage documentation and study files in electronic Trial Master Files.
(6) Assist in data management activities including review of eCRF data and database report generation
(7) Performs initiation, interim and close-out site visits in accordance with SOPs when needed

Profile:

2-3+ years of experience in Oncology as a Clinical Research Associate. An experience in hemato-oncology is a must, but is not required. Must have experience managing study startup, monitoring, and closeout activities of multicenter trials.

Only candidate with a native level in Norwegian and currently based in Norway will be considered for this role. Due to COVID-19 all other candidates based outside of Norway in Scandinavia cannot be considered.