Senior Initiation Clinical Research Associate - FSP

Parexel FSP is hiring two Senior Initiation Clinical Research Associates. Candidates could be based in Mexico, Argentina or Brazil. The position will be remote.

The Senior Initiation Clinical Research Associate will be responsible for ensuring the completeness of Site Essential Document Packages as well as the Site Regulatory Packages (SRP) required to achieve site initiation and activation status.  This also includes the renewal of critical essential documents in the event of protocol amendments introduced during the Final Approved Protocol to Last Patient, First Visit. Areas of additional responsibility include the tracking of document translations requirements, site SRP reviews and approvals, and required training activities.  
Will ensure the clinical study insurance documents are current and filed in the electronic Trial Master File (TMF) from the beginning of the study until study completion in compliance with SOPs and guidance.
Introduces specialized industry-leading and/or emerging concepts to develop innovative business solutions. Serves as an advisor, mentor, internal consultant, and/or helps drive new initiatives

Additionally, may be responsible for planning and delivery of European Union Clinical Trials Directive/Regulation (EUCTD/R) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS). Coordination with Regulatory Affairs, Clinical Trial Management and Clinical Transparency will be core to the role.

Additionally, may serve as the primary contact for acquiring insurance documents on behalf of the clinical study team.  May serve as the main liaison between the sponsor/CRO and the insurance broker/carrier.  The Associate Manager Clinical Documentation – May ensure the clinical study insurance documents are current and filed in the electronic Trial Master File (TMF) from the beginning of the study until study completion in compliance with SOPs and guidance.

Required experience:
A bachelor's degree and 3 years in essential or regulatory document management in Pharmaceutical /CRO industry, understanding of clinical study start up requirements and working knowledge of relevant documentation.