Source Document Specialist

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

📋 Description

• Care Access Research is currently seeking to hire a full-time, remote Source Document Specialist.

• The Source Document Specialist will be tasked with creating, maintaining, and controlling accurate versions of source documents (both eSource and paper) for each clinical trial to validate trial activities.

• All source documents will adhere to GCP Guidelines and 21 CFR Part 11 Compliance, in addition to Care Access Research's internal Standard Operating Procedures (SOP).

• The initial creation of e-Source will utilize all available protocol-specific documents to design source documents that are precise and comprehensive, ensuring that the source document captures all the necessary data for a clinical trial.

• Develop paper source templates, worksheets, and supplemental sources for visits based on a thorough review of protocol-defined exams, tests, evaluations, and assessments.

• Review draft sources to ensure accuracy and completeness, ensuring that the source document is prepared to record all required data for the trial.

• Coordinate the initial review and updating process of source documents.

• Maintain version control for all source documents.

• Update existing sources as necessary in accordance with protocol amendments.

• Organize, file, distribute, maintain, and archive source documents for each clinical trial.

• Oversee daily communication with site staff and various internal departments.

⛳️ Requirements

• Prior experience as a Clinical Research Coordinator with a background in diverse and complex clinical trials is preferred.

• Proficient in e-Source build and design (e.g., CRIO/Clinical Conductor).

• Experienced in creating and revising paper source templates.

• Ability to interpret clinical trial protocols and determine how to design comprehensive and accurate source documents.

• Self-motivated, detail-oriented individual who can work independently while prioritizing tasks and meeting project deadlines.

• Capability to create source documents using Excel.

• Willingness to learn computerized programs utilized for creating eSource.

• Strong verbal and written communication skills, particularly in a remote work setting, including editing, proofreading, and grammar proficiency.

• Highly organized.

• IT skills encompassing Word, Email, Direct Messaging, digital document management, and advanced Excel expertise.

• Ability to collaborate effectively within a team.

🏝️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays

• 100% Employer paid medical, dental, and vision insurance plan options

• Health Savings Account and Flexible Spending Accounts

• Bi-weekly HSA employer contribution

• Company paid Short-Term Disability and Long-Term Disability

• 401(k) Retirement Plan with Company Match