SSU & Regulatory Specialist I

Job 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.

Core Responsibilities

Essential Functions:

1. 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:

2. 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.

3. 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..

4. 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%).

Note: If there are additional responsibilities that are specific to an individual employee, department, country, or other grouping, please use the Job Description Addendum Template.

Skills & Attributes

BA/BS degree in the science/health care field, legal degree, or equivalent combination of education and experience. Knowledge of and a clear understanding of the overall drug development process. Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations and European Union Directive as well as any applicable rules applicable locally. Demonstrated clinical development and clinical research knowledge. Excellent verbal, interpersonal, and written communication skills. Good record retention and customer service skills. Proficient in the use of computer and software systems (e.g., Excel). Ability to successfully support internal and external customers. Ability to develop, organize, and manage multiple tasks. Ability to work independently.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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