[Novotech] PMS CRA I 채용

Qualifications & Experience: 

• ㆍMinimum Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. Preferably at least six months experience of working in the research, pharmaceutical industry or a related field. Must have good time management skills, attention to detail, be able to work well in a team and be computer literate.

Responsibilities: 

• ㆍ In collaboration with the primary CRAs, collect, track and maintain essential documents and study trial files, according to the requirements of ICH GCP, local guidelines and Novotech (or sponsor) SOPs and filing plan. 
  

  ㆍ Provide in-house support to the primary CRA’s site e.g. be able to contact study co-ordinators / investigators on behalf of the CRA to request information or resolve issues. 

  ㆍ Assist with the set up and maintenance of tracking systems to track study progress as designated by the Project Manager (PM) i.e. CTMS set up and maintenance, CRF & query flow, safety reports, regulatory documents, contact records etc. Provide updates on study progress to CRA/PM as required by the PM. 

  ㆍ Co-ordinate distribution of study supplies to clinical sites, including tracking of clinical trial supplies (i.e. Investigator Site Files, study drug, CRFs, Investigator’s Brochure (IB), Protocols, lab kits) according to the logistics of the study. Ensure safe and orderly storage of study materials at Novotech, and present stock reports as requested by the PM.

  ㆍ Be aware of and adhere to company process in areas relevant to a CRA I. Be quality focussed in performance of duties. Adhere to Novotech SOPs and policies and be mindful of the role of Novotech Ambassador when carrying out CRA I role