Senior Initiation Clinical Research Associate

Parexel FSP is looking for **Senior iCRAs**in **Argentina, Brazil and Mexico**

**Summary**

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 serve as the primary contact for acquiring insurance documents on behalf of the clinical study team. May serve as the main liaison between Client/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.

**Responsibilities**

**Site Initiation and Regulatory Packages**
- Gathers all documents required for the purposes of enabling Site Initiation; includes the compilation of documents from multiple internal stakeholders and supporting functions to then distribute to the site in a structured and time sensitive manner.
- Identifies and tracks documents that require translations/linguistic validations and works with translation support services to define the scope of work and critical timelines for deliverables.

**Study Investigator Site Essential Document Oversight**
- Serves as study expert on investigator site essential documentation
- Develop and maintain sponsor's documentation of expectations / standards of investigator site essential documentation
- Provide training to internal and external study teams on the expectations / standards of investigator site essential documentation
- Review investigator site essential documentation packages from CROs per process and sample as needed
- May collaborate directly with sites regarding collection of documents and IRB timelines for site activation and ensure that relevant documents are uploaded into the eTMF.
- Collect study specific metrics and feedback and provide to internal and external study teams (including CRO partners) and sponsor's management as required.
- Assists in inspection readiness activities in relation to site start up documents
- Participates in lessons learned opportunities to retrain study teams and CROs understand what has worked or not to prevent repeating past mistakes.

**Study Team Interaction**
- May represent Site Start up on cross-functional study team (s) and/or sub-team(s); Attends Kick Off meetings to present SSU Roles and Responsibilities
- Works with and provides status to study team to ensure essential documentation packages are approved for initial drug shipments according to study timelines. Supports Clinical Study team in ensuring regulatory documents are submission and audit ready Escalates as necessary
- Collaborates with CRO and internal team to ensure timely feedback / resolution of document issues
- Provides support for overall study and site timelines and milestone projections
- Management of investigator and Site usability and due diligence checks
- Supports deliverables for site initiation and activation

**Additionally, for assigned studies in the EU region**:

- Engage with Regulatory Affairs functional representatives to plan the Clinical Trial Application (CTA) for any one up and coming clinical trial that involves EU countries
- Engage with Clinical Trial Management functional representatives to determine key study milestones and country allocation strategies
- Coordinate with Clinical Transparency regarding any redactions required for relevant documents identified for CTA submissions
- Identify the list of Member State/countries participating in any one clinical trial and capture the information within the CTIS database
- Identify the Institutions and Primary Investigators for each Member State/Country where the clinical trial will be conducted and capture relevant contact information within the CTIS database
- Locate the documents that are deemed applicable at the Member State/country and/or site level for the purposes of Clinical Trial Application (CTA) submissions and upload them into the CTIS database
- Maintain the list of participating Member States/countries, Institutions and Primary Investigator over the life cycle of the study to ensure alignment and synchroniza