_{07th April, 2025}

Avance Clinical is a Contract Research Organization which offers specialized services supporting drug development for the pharmaceutical and biotechnology industry.

We are looking for an SSU/Contracts & Start-Up Specialist ( CSU I) is responsible for executing site start up activities including review of initial regulatory documents, confidentiality agreements (CDAs) and clinical trial agreements (negotiating legal terms and site budgets) (CTAs) from the point of site activation to activation ready as well as processing site payments through to site close, in accordance with the protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements. They will report study progress to the Manager, Investigator Contracts and Payments.

Responsibilities:

• Execute on integrated site start-up timelines and regularly report progress. If planned timelines are not reached escalate the issue as soon as identified.
• Serve as the primary contact with the Investigator sites and project manager for CDAs, CTA and budget negotiations.
• Report on status/metrics and communicate outcomes to internal project team.
• Drafting, review, preparation, negotiation and execution of CDA templates with sites and vendors.
• Draft site-level contract template; development, negotiation and completion of CTAs.
• Contribute to Institutional Review Board (IRB) /Ethics Committee (EC) submissions and approvals for assigned protocols (and subsequent amendments), development of local language materials including Informed Consent Forms per local regulations, interactions with IRB/EC or investigator sites.
• Draft clinical trial public registry submissions and on-going maintenance.
• In conjunction with clinical operations team, manage the collection of Essential Documents leading to site activation.
• Drafting, review, preparation, negotiation and execution of CTA and site budget amendment templates.
• Review proposed site budget items for Fair Market Value (FMV) analysis to determine audit risk.
• Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
• Review site invoices to determine which fees are eligible for payment and generate invoice for submission to accounts payable.
• Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.