Ref #: 31733

Employment type: Permanent - Full-Time

Location: France

Posted: 01-Sep-2021

Description

Description:

? Partners with the CTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.
? Supports the local study team in performing site feasibility and/or country feasibility.
? Maintains site level protocol information in Trial Management Systems (e.g. CTMS).
? In liaison with the CTM, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.
? Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process.
? Supports the CTM or, where applicable the CRA, in providing the current and complete documents requested by the IEC/IRB and HA.
? Supports the CRA/CTM in collecting and maintaining all documents throughout the trial and posttrial in both eTMF (i.e., IF/LAF sections) and paper files.
? Distributes, collect, review, and track regulatory documents, agreements and training documentation.
? Collects and tracks Financial Disclosure information at appropriate time points.
? Complies with relevant training requirements.
? Region specific (to be specified):
o Negotiates site requested changes to the Confidential Disclosure Agreement; checks investigators and IEC/IRBs against exclusion databases, IEC/IRB registrations. Alerts CTM of any findings.
o Prepares Trial Center File and prepare or co-ordinate the development of any other document and review them for completeness and accuracy.
o Assist the CTM in conducting local investigator meeting or in making arrangements for the investigators participating in an international meeting.
o May be assigned to assist in document review for outsourced trials.
o Support the CTM in drug distribution process.
o Provide administrative and logistical support to the CTM/CRA in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and
correspondence and other relevant tasks as appropriate
o Supports the CTM (e.g., in US) in compiling the List of Investigators for CSR (Appendix 1.4.1) is accurate and complete.
o Maintains and updates CTSRS contact information to ensure appropriate SUA distribution and if applicable disseminates SUA packet.
o Maintains and transmits ERIS Transmittal Summary of 1572 and PI CV to Regulatory Affairs for NDA submission.
o Archives off-site paper Trial Master File.
o Supports the CTM in compiling accurate/complete regulatory documents for submission to Health Authority at country level.
o Upon request from CTM, reviews site specific Informed Consent Form (ICF) for completeness to facilitate the approval of changes to mandated J&J language in collaboration with legal department, and if applicable, Contract and Grants Associate.
? Primary interfaces: Functional Manager, Local Trial Manager and Site Manager(s) for assigned clinical studies.
? Other Internal Interfaces: CTM, SM, Quality&Compliance Manager/Specialist, Contracts and Grants, Clinical Trial Assistant team.
? External Interfaces: Investigators and their delegates at site.

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