# CRA SSU with at least 2 years of regulatory experience - Sponsor dedicated - Argentina Client Based

**Company**: Syneos Health
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/ARG-Remote/CRA-SSU-with-at-least-2-years-of-regulatory-experience---Sponsor-dedicated---Argentina-Client-Based_25105638?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_a6108aae-970

## Description

Syneos Health is seeking a CRA SSU with at least 2 years of regulatory experience. The successful candidate will be responsible for providing quality on deliverables at the country level and following project requirements and applicable country rules.

**Job Responsibilities**

- General – Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules, with oversight from the SSU Country Manager.

- Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with contingency plan to mitigate impact, and escalates the issue as soon as identified.

- Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.

- Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.

- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

- Responsible for one or more of the following functions at the country level:

+ Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SAM.   + Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision.   + May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues.   + Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.   + May be asked to perform: Local Investigator Contract and Budget Negotiator – Supports the SAM to agree on country template contract and budget.

**Benefits**

- Career development and progression

- Supportive and engaged line management

- Technical and therapeutic area training

- Peer recognition and total rewards program

- Total Self culture – where you can authentically be yourself

## Skills

### Required
- regulatory experience
- clinical trials
- Good Clinical Practice (GCP)
- Standard Operating Procedures (SOPs)

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/ARG-Remote/CRA-SSU-with-at-least-2-years-of-regulatory-experience---Sponsor-dedicated---Argentina-Client-Based_25105638?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)