Study Start Up Associate II

ICON plc

Study Start-Up Associate II coordinating regulatory submissions, site readiness, and document collection for ICON’s global clinical research organization. Supporting clinical trials for new medicines and medical devices.

Posted 8/13/2026full-timeRemote • 🇲🇾 MalaysiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in coordinating clinical trial site start-up activities, including regulatory document preparation, IRB submissions, and compliance with ICH/GCP and MDR standards. Proficient in managing multiple studies and maintaining effective communication with clinical research site personnel.

Highest-signal resume keywords

Clinical Trial Site Start-Up CoordinationRegulatory Document ManagementIRB Submission and ApprovalClinical Trial Management Systems (CTMS)Customer Service Focus

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document PreparationClinical Research CoordinationSite Informed Consent Forms (ICFs)Study Start-Up TrackingQuality Audits SupportCompliance with ICH/GCPMDR KnowledgeDocument Control SystemsClinical Study Site ManagementEnrollment Support

Soft Skills

Clear CommunicationTeam CollaborationProblem SolvingPresentation SkillsCustomer Service Orientation

Tools & Technologies

Siebel CTMSVeevaETMF SystemsCTMSRegulatory Tracking Systems

Industry Keywords

Clinical ResearchMedical Device ExperienceRegulatory ComplianceIRB/EC SubmissionClinical Trial Activities

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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