Country Study Start-Up Architect

Spectraforce Technologies, Inc.; Illinois; On-site; USD 90,000 - 130,000; Full time

Job summary

Spectraforce Technologies, Inc. seeks a Country Study Start Up Specialist II to lead start-up and maintenance activities for assigned studies and sites in-country. This onsite-leaning role is based in Abbott Park, IL, with on-site preference but flexibility.

The successful candidate will coordinate with cross-functional teams, ensure ALCOA data quality, manage regulatory submissions, and drive activation timelines while maintaining SSU metrics and readiness.

Qualifications

• Bachelor's Degree in health care or scientific field highly preferred or equivalent experience.
• 3–5 years of clinical research experience; 1+ years study start up in designated region preferred.
• Experience working with remote/virtual teams.
• Strong interpersonal, adaptable communication, and ability to manage multiple priorities.
• Working knowledge of ICH and GCP guidelines and local regulatory environment.

Responsibilities

• Ensure on-time, high-quality start-up and maintenance activities for assigned sites and studies.
• Coordinate with cross-functional teams on activation plans and risks.
• Collect essential documents from sites and perform quality checks (ALCOA).
• Prepare ethics submissions and local documents including ICF customization.
• Coordinate regulatory submissions and approvals with Regulatory and CTS.
• Track start-up activities and maintain Vault SSU data and KPIs.
• Train and mentor new Country Start Up Specialists.

Skills

Interpersonal skills

Remote/virtual collaboration

Education

Bachelor's Degree in health care or scientific field

Job description

Spectraforce Technologies, Inc. seeks a Country Study Start Up Specialist II to lead start-up and maintenance activities for assigned studies and sites in-country. This onsite-leaning role is based in Abbott Park, IL, with on-site preference but flexibility.

The successful candidate will coordinate with cross-functional teams, ensure ALCOA data quality, manage regulatory submissions, and drive activation timelines while maintaining SSU metrics and readiness.