Covance is searching for the support of the Study Start Up Assistant to be office based in Munich.
Provide administrative support to the Start Up team through contact and liaison with investigative sites during study maintenance and – when assigned – site start-up (SSU) activities. Assist the regional document review team with uploading study documents to eTMF. Administer the signature process for site contracts and related documents. Support collection of the required investigator and regulatory documents to ensure EC applications are made within the timelines agreed with project management and SU team
Duties may include, but are not limited to:
o Assist in the collection, review, processing and tracking of regulatory & investigator documents required for study site activation and maintenance in accordance with applicable SOPs, GCP, ICH guidelines, and/or Study specific requirements and plans
o Follow-up with investigative sites regarding document completion/submission.
o Maintain and update document tracking information in CTMS, eTMF and other study specific systems.
o Responsible for maintenance of site address and personnel information in the study database of allocated country(ies). Assist in tracking study personnel changes and assist the processing of new documents according to GCP/ICH guidelines.
o Assist with revision of required study documentation as advised when study amendments occur.
o Assist in the preparation of new investigator submission packages to Central/Local Ethics Committees as appropriate.
o Where appropriate liaise with Ethics Committee(s) regarding investigator submission/approval issues.
o Support performance of quality reviews of documents in accordance with instructions of senior staff and relevant processes.
o Administer the signature process in accordance with defined processes for all site contracts and related documents. Track and maintain appropriate databases in support of site contract activities
o Liaise with relevant Sponsor and Covance teams to ensure appropriate site and Sponsor signatures are obtained for relevant documents and track and progress site contracts and review requests in accordance with management instructions.
o Where trained to do so, act as subject matter expert for the creation of investigator site budget using appropriate software. o Assist with data entry and admin support to the document review team regionally.
o Assist with eTMF uploading of study documents.
o Upload, check, correct and maintain study documents for document review in the study eTMF regionally and send study documents for document review to eTMF archivist after release. o Provide study documents for document review to the client as per study specific Investigator Package Plan
o Perform other duties as assigned by management.
High School Diploma or equivalent / Secretary/Medical Administrative and experience of clinical research activities
Preferred: advanced scientific academic degreee (PhD, MSc)