Source Document Specialist

Role Overview

• Care Access Research is currently looking to hire a full time, remote, Source Document Specialist.
• The Source Document Specialist will be responsible for creating, maintaining, and controlling accurate versions of source documents (eSource or paper) for each clinical trial to substantiate trial activities.
• All source documents will follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to Care Access Research internal SOP.
• Initial creation of e-Source with use of all available protocol specific documents to design source documents that are accurate and complete and to ensure that the source document is equipped to record all the required data for a clinical trial.
• Create paper source templates, worksheets, supplemental source for visits based on detailed review of protocol-defined exams, tests, evaluations, and assessments.
• Review draft source and ensure it is accurate and complete and to ensure that the source document is equipped to record all the required data for the trial.
• Coordinate initial source review and update process.
• Maintain version control of all source documents.
• Update current source as needed per protocol amendments.
• File, maintain, distribute, organize, and archive source for each clinical trial.
• Manage daily communication with Site staff and other internal departments.

Requirements

• Experience as a Clinical Research Coordinator with diverse and complex clinical trials preferred.
• Skilled and proficient with e-Source build and design (e.g. CRIO/Clinical Conductor)
• Skilled in creation and revision of paper source templates.
• Ability to interpret clinical trial protocol and determine how to design complete and accurate source documents.
• Self-motivated, task oriented, detailed person who can work independently prioritizing responsibilities and adhering to project deadlines.
• Ability to create source documents in Excel.
• Willing to learn computerized programs used in creating eSource.
• Good verbal and written communication skills, especially for the remote work environment, including editing, proofreading, and grammar skills.
• Highly organized.
• IT Skills including Word, Email and Direct Messaging, digital document maintenance, and expert level in Excel.
• Ability to work well within a team.

Tech Stack

• Google Cloud Platform

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