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 :
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 :
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.
includes safety notifications as required by local rules.
Produces site-specific contracts from country template. Submits proposed contract and budget for site..
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 :
Associate’s Degree or equivalent combination ofeducation and training.