Study Start Up Associate II

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Coordinate clinical trial site start-up activities for regulatory document preparation and approval • Coordinate IRB submissions and approvals • Customize and negotiate site informed consent forms (ICFs) • Collect essential regulatory documents • Support enrollment, follow-up, and closure of clinical trial activities • Coordinate site regulatory submissions and document collection for allocated clinical research sites • Manage regulatory documents across multiple studies and division portfolios • Build clinical research site relationships and provide site start-up regulatory expertise • Track IRB/EC submission timelines and approval status • Resolve site start-up challenges to protect service-level agreements and study goals • Prepare, complete, and track regulatory, ICF, and legal documentation • Document site and investigator readiness across multiple studies • Support internal quality audits and regulatory inspections • Maintain study start-up and close-out trackers, site metrics, and site documents in CTMS/eTMF systems • Provide leadership updates on start-up activities, investigator readiness, and regulatory status • Escalate challenges to investigators, site coordinators, clinical study leads, and other stakeholders • Ensure compliance with ICH/GCP, MDR, GDPR, SOPs, work instructions, policies, and procedures

🎯 Requirements

• Bachelor’s Degree, or an equivalent combination of experience and education • 2+ years’ experience in clinical/scientific research • Medical device experience, specifically clinical study site start-up experience within the US • Ability to support several studies and/or personnel simultaneously in a fast-paced environment • Ability to work in a team environment • Clear, concise written and verbal communication and presentation skills • Comfortable interacting with clinical research site personnel by phone and email • Remote based • Preferred: Research Coordinator, In-House Clinical Research Associate, Clinical Research Associate, or Study Start-Up Specialist experience • Preferred: Experience with clinical trial management systems such as Siebel CTMS or Veeva • Preferred: Experience with clinical document control systems/eTMF • Very high focus on customer service • Proficiency in English • Legal right to work in the country where the role is based

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways