2 дня назад
Sponsor Dedicated Regulatory & Start-Up Specialist 2
60 300 - 157 100$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Sponsor Dedicated Regulatory & Start-Up Specialist 2 (Clinical Research): Managing country-level site activation and regulatory start-up activities for clinical studies with an accent on document quality, regulatory compliance, and project timelines. Focus on coordinating investigative sites and project teams, tracking ethics and regulatory approvals, maintaining study systems, and applying GCP/ICH requirements.
Location: Durham, North Carolina, United States of America
Salary: $60,300–$157,100 annualized base pay
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Serve as the single point of contact for investigative sites, Site Activation Managers, project management, sponsors, and internal departments.
- Perform country-level start-up and site activation activities in line with applicable regulations, SOPs, work instructions, and project requirements.
- Prepare, review, distribute, and quality-control site regulatory, ethics, informed consent, and investigator documents.
- Track document approvals, execution, and Investigator Pack release progress against project timelines.
- Maintain study systems, databases, tracking tools, planning records, and site performance metrics.
- Support project planning, timeline management, monitoring measures, and contingency planning.
Requirements
- Bachelor’s degree in life sciences or a related field, plus 3 years of clinical research or relevant experience, or an equivalent combination of education, training, and experience.
- At least 3 years of clinical research experience, including 1 year in a leadership capacity.
- In-depth knowledge of clinical systems, procedures, corporate standards, and the regulated clinical trial environment.
- Knowledge of drug development, applicable regulatory requirements, SOPs, and company standards.
- Ability to apply GCP/ICH guidelines, work independently, prioritize tasks, and manage multiple projects.
- Strong negotiation, communication, organizational, interpersonal, and relationship-management skills.
Culture & Benefits
- Full-time employment with health, welfare, and other benefits.
- Potential incentive plans, bonuses, and additional compensation depending on the position.
- Equal opportunity employment commitment.
- Work focused on accelerating the development and commercialization of medical treatments and improving patient outcomes.
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