SSU & Regulatory Specialist I - office based in Buenos Aires
Syneos Health
Argentina- ARG-BuenosAires-Avda-del-Liber
hace 1 día

Summary :

Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials.

Responsible for providing delivery and expertise in one or more of the following functional areas : investigator site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation.

Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards.

Ensures an efficient start-up process on assigned studies. May act as main contact with Regulatory Authorities (RA) and Central / Regional Ethics Committees (ECs).

Under the direction of the Project Manager (PM) or Site Start-up Lead (SSUL) as appropriate, may directly interact with Customers regarding requirements from RA or other local regulatory party.

Accountable to the PM / SSUL at the project level and line manager for deliverables.

Essential Functions :

  • General - Assumes responsibility on quality deliverables at the country level; follows project requirements and applicable country rules.
  • Forecasts submission / approval timelines and ensures they are complied; if forecasted timelines are not reached : provides clear rationale for delays, provides 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 Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner and keeps training records updated accordingly.

    Ensures continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).

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

  • Local Submissions Specialist - Follows the project direction and expertise provided by the designated country start-up advisor (CSA) and SSUL.
  • May serve as the primary point of contact for the SSUL / PM (or designee) during start-up on allocated projects. Reviews essential document packages for site activation and may also be involved in essential document collection from site.

    Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.

  • Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country;
  • includes safety notifications as required by local rules.

  • Local Site ID and Feasibility Support - Works with site selection lead and PM / SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
  • Produces site-specific contracts from country template. Submits proposed contract and budget for site..

  • Local Investigator Contract and Budget Negotiator - Works with contracts lead to agree on site-specific country template contract and budget.
  • Produces site-specific contracts from country template. Submits proposed contract and budget for site. Negotiates budget and contract with site and via contracts lead with Sponsor until resolution of issues and contract execution.

    Other Responsibilities :

  • Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
  • Requirements :

    Associate’s Degree or equivalent combination ofeducation and training.

  • Good understanding of clinical trial process acrossPhases II-IV and ICH GCP, Ability to interact effectively and appropriatelywith investigative site personnel.
  • Good organizational skills and good attention todetail, with proven ability to handle multiple tasks effectively.
  • Ability to take direction from multiple individualsand set priorities accordingly.
  • Ability to effectively communicate across multiplefunction groups (clinical team, PM, Director).
  • Demonstrated ability to work independently, as wellas part of a team. Utilize problem-solving techniques effectively.
  • Quality-driven in all managed activities.
  • Flexibility and willingness to adapt to rapidlychanging environment and learn / perform new functions.
  • Strong computer skills, including Word, Excel,PowerPoint, Publisher
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