[Hiring] Study Start Up Specialist @Fortrea

Role Description

Support the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives.

• Generate and provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools.
• Proactively identify and escalate issues that arise related to support SSU deliverables.
• Effectively execute against assigned activities within SSU.
• Support implementation of standards for global SSU team.
• This may include:
  • Oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other site activation requirements.
  • Implementation of the SSU Strategy for assigned region during the study start up period.
  • Building relationships with internal counterparts and site staff to support successful site activation strategies.
  • Projecting site activation timelines and appropriately escalating when things get off track.
  • Adhering to process and tools designed to support the SSU team with day-to-day activities.
  • Leading the preparation of study level essential document templates.
  • Aiding in the preparation of content for Regulatory submissions.
  • Handling ICF negotiations and facilitating any required escalations.
  • Preparation and submission of IMP Release Packages.
  • Maintaining accurate and timely information in relevant clinical systems.
• Responsible for complying with regulations and guidelines and ensuring adherence in support of assigned clinical trials. This position has no direct reports but may provide guidance/oversight to contract staff.

Qualifications

• BS/BA degree or Associates degree with ≥2 years of experience in the health care field or direct clinical trial related experience.
• Must have knowledge of clinical trial conduct.
• General knowledge of drug development and ICH/GCP guidelines.
• Requires proven project management skills.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Advanced / Fluent in English.
• Minimal (0-5%) travel required.

Benefits

• Please, submit your English resume.
• Learn more about our EEO & Accommodations request here.