Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials.
Responsible for delivery, with moderate oversight from the SSU Country Manager and specialist knowledge in one or more of the following functional areas : investigator site contracts, ethics and regulatory submissions, and reviews 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 and some level of supervision of the Project Lead (PL) or SSUL as appropriate, may directly interact with Customers when receive requirements from RA or other local regulatory party.
Accountable to the PL / SSUL at the project level and line manager for deliverables. At a project level, may act as SSUL for local studies.
May provide support as the Country Start-Up Advisor (CSA).
if forecasted timelines are not reached : investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified.
May serve as a point of contact for the PM / SSUL (or designee) during start-up on allocated projects. Complies and / or 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, with moderate oversight from the SSU Country Manager.
level intelligence on start-up (SU) and clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTR team, is maintained on the central repository, e.
g., Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications / applications to any other local / federal / national body, and import / export license applications where these are obtained with RA applications.
In absence of legal advisor or dedicated subject matter may provide support for data protection at the country and provide guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-
up group to adapt to local requirements. This may include the Principal Investigator / Informed Consent and the Confidential Disclosure Agreement / contract template.
Provides input in local SOPs and WI. Supports the creation of internal training materials on local legislation requirements.
Provides input to the team to assist with EC or CA issue resolution at the country level.
Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site.
Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues and contract execution.
Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.