Study Start Up Specialist

This is a fully remote position, open to applicants in Poland.

📋 Description

• Oversee the initiation activities for assigned studies in line with timelines, protocol requirements, standard operating procedures (SOPs), and ICH-GCP guidelines.

• Gather, evaluate, manage, and monitor regulatory and investigator documentation necessary for site activation.

• Prepare and facilitate submissions and amendments to Ethics Committees/IRBs as well as notifications to regulatory authorities.

• Ensure that submission documentation meets quality standards and is complete.

• Modify informed consent forms to comply with local regulations and company policies.

• Coordinate contracts with investigators and assist in contract negotiations.

• Engage in site identification, feasibility studies, and site assessments.

• Keep accurate start-up information in company databases and repositories.

• Assist in the maintenance of the Trial Master File and ensure timely filing of documents.

• Support study setup, site activations, status reporting, and project tracking.

• Contribute to enhancements in Clinical Operations processes.

• Aid in audit and inspection preparedness.

• Assist with investigator payments, invoice tracking, financial reconciliation, and clinical study reporting as needed.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences or a related discipline is preferred.

• At least 1-2 years of experience in Study Start-Up (SSU).

• Strong knowledge of ICH-GCP guidelines and relevant regulatory requirements.

• Experience in managing site start-up documentation and regulatory submissions.

• Familiarity with CTIS submissions.

• Background in site contract negotiations.

• Experience with MDR submissions is a plus.

• Must be able to work from home in Poland.

🏝️ Benefits

• Competitive salary package.

• Comprehensive benefits package.

• Opportunities for personal and professional development.

• A collaborative and innovative work environment.

• Fully remote work options.