eSource Architect

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

📋 Description

• Develop eSource for new studies in accordance with protocol specifications.

• Distribute eSource to relevant sites and work together with local staff to implement site-specific eSource requirements.

• Act as a subject matter expert for eSource development and provide mentorship to clinical sites.

• Create template logs, including adverse event (AE) and deviation logs, within the eSource platform for consistent centralized reporting.

• Liaise with Finance, QA, Sites, and other teams to ensure the eSource meets all necessary requirements.

• Provide comprehensive organizational training to guarantee staff are well-trained and proficient in eSource development.

• Oversee and manage the creation of eSource.

⛳️ Requirements

• A minimum of 2 years of clinical research experience (CRC, QA, Source, CRA) is required.

• At least 2 years of knowledge of ICH/GCP guidelines and FDA regulations gained through practical work experience is necessary.

• A BA/BS degree is preferred.

• Familiarity with medical terminology is required.

• Proven proficiency in Microsoft Office applications (Word, Excel, PowerPoint, and Outlook).

• Demonstrated capability to think strategically and lead change initiatives.

• Ability to establish effective working relationships and collaborate within the organization.

• A problem-solving mindset, goal-oriented approach, and a team-player attitude are essential.

• Excellent verbal and written communication skills are necessary.

🏝️ Benefits

• Competitive salary plus annual performance incentives.

• Medical, dental, and vision insurance coverage.

• Health Savings Accounts (HSA).

• Flexible Spending Accounts (FSA).

• 401(k) plan with company matching contributions.

• Paid time off (PTO) along with company holidays.

• Options for disability, accident, and life insurance.

• A mission-driven culture dedicated to advancing medicine and enhancing patient outcomes.