Study Start Up Associate Opportunities at ICON PLC
- ICON Hiring Study Start-Up Associate II – Clinical Research | Remote (South Korea) | 2+ Years Experience
- Company Overview
- Job Role & Responsibilities
- Regulatory Document Preparation & Submission
- Study Start-Up Coordination
- Compliance & Process Improvement
- Eligibility / Qualifications
- Educational Qualification
- Experience
- Key Skills Required
- Location & Employment Details
- Application Process
- Frequently Asked Questions (FAQs)
- 1. Is this role fully remote?
- 2. What experience is mandatory for this position?
- 3. What regulatory knowledge is required?
- 4. Does this role involve direct interaction with regulatory authorities?
- 5. Is this role suitable for freshers?
- Summary
ICON Hiring Study Start-Up Associate II – Clinical Research | Remote (South Korea) | 2+ Years Experience
ICON Strategic Solutions is hiring for the position of Study Start-Up Associate II in Seoul, South Korea, with a home-based remote working model. This is a full-time opportunity within the Clinical Research and Regulatory Start-Up division. The role is ideal for life sciences graduates with a minimum of 2 years of experience in clinical research, regulatory affairs, or study start-up activities.
If you have hands-on exposure to clinical trial applications, ethics committee submissions, regulatory documentation, and ICH-GCP compliance, this role offers strong career growth in global clinical trial management and regulatory operations. As clinical research continues to expand across Asia-Pacific, skilled study start-up professionals are in high demand to ensure faster site activation and regulatory approval timelines.
Company Overview
ICON plc is a global healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies in developing innovative therapies. With operations across multiple countries, ICON delivers full-service clinical development solutions including clinical trial management, regulatory strategy, data management, biostatistics, and pharmacovigilance.
ICON Strategic Solutions partners with sponsors to accelerate clinical development programs while ensuring compliance with international regulatory standards. The organization is known for maintaining strong adherence to ICH-GCP guidelines, regional regulatory requirements, and ethical clinical research practices.
By joining ICON, professionals contribute directly to advancing new treatments, improving patient outcomes, and supporting global clinical trial operations.
Job Role & Responsibilities
As a Study Start-Up Associate II, you will play a central role in initiating clinical trials by ensuring regulatory submissions and approvals are completed efficiently and accurately.
Regulatory Document Preparation & Submission
- Lead preparation and submission of clinical trial applications (CTA) and regulatory documentation.
- Manage ethics committee submissions and coordinate responses to regulatory agency queries.
- Ensure documentation complies with ICH-GCP and local South Korean regulatory requirements.
- Maintain accurate records of submissions, approvals, and regulatory correspondence.
Study Start-Up Coordination
- Liaise with internal study teams, sponsors, CRO partners, and external regulatory bodies.
- Track timelines for regulatory approvals and ensure site activation milestones are met.
- Provide guidance to cross-functional teams on study start-up best practices.
- Support documentation workflows and regulatory tracking systems.
Compliance & Process Improvement
- Ensure adherence to global clinical trial regulations and local health authority standards.
- Participate in process improvement initiatives to streamline study start-up timelines.
- Identify risks in regulatory submissions and escalate issues proactively.
- Contribute to maintaining audit readiness and inspection preparedness.
This position is critical in ensuring smooth clinical trial initiation, regulatory compliance, and timely activation of research sites.
Eligibility / Qualifications
Educational Qualification
Bachelor’s degree in Life Sciences or related field.
Relevant Courses: B.Pharm, M.Pharm, BSc Clinical Research, MSc Clinical Research, BSc Biotechnology, MSc Biotechnology, BSc Life Sciences, MSc Life Sciences, Nursing, Public Health, Biomedical Sciences.
Experience
- Minimum 2 years of experience in clinical research or regulatory affairs.
- Direct experience in study start-up activities, including CTA and ethics submissions.
- Familiarity with regulatory frameworks governing clinical trials.
Key Skills Required
- Strong knowledge of ICH-GCP and local regulatory requirements in South Korea.
- Excellent project management and organizational skills.
- Ability to manage multiple submissions and deadlines simultaneously.
- Strong communication and stakeholder coordination skills.
- Attention to detail with a compliance-focused approach.
Location & Employment Details
- Location: Seoul, South Korea
- Work Model: Remote / Home-Based (ICON Strategic Solutions)
- Employment Type: Full-time
- Job Reference: JR145448
Salary details are not publicly disclosed. Compensation is competitive and aligned with industry standards for clinical research and regulatory start-up professionals in South Korea.
ICON offers comprehensive employee benefits including health insurance options, retirement planning programs, life assurance, employee assistance programs, flexible benefits, and work-life balance initiatives.
Application Process
Interested candidates can apply directly through ICON’s official career portal:
Applicants are encouraged to ensure their CV highlights clinical trial start-up experience, regulatory submissions exposure, and knowledge of ICH-GCP guidelines before applying.
Frequently Asked Questions (FAQs)
1. Is this role fully remote?
Yes, the role is home-based in South Korea under ICON Strategic Solutions.
2. What experience is mandatory for this position?
A minimum of 2 years in clinical research or regulatory affairs with specific experience in study start-up activities.
3. What regulatory knowledge is required?
Candidates must understand ICH-GCP and local South Korean clinical trial regulations.
4. Does this role involve direct interaction with regulatory authorities?
Yes, the associate will coordinate regulatory submissions and communicate with ethics committees and health authorities.
5. Is this role suitable for freshers?
No, prior clinical research experience is required.
Summary
| Company | ICON Strategic Solutions |
|---|---|
| Vacancies | Study Start-Up Associate II |
| Required Education | Bachelor’s in Life Sciences, B.Pharm, M.Pharm, BSc/MSc Clinical Research, Biotechnology, Nursing, Public Health |
| Experience | Minimum 2 Years in Clinical |
To apply for this job please visit careers.iconplc.com.
