Source Document Specialist

Summary

Join Care Access Research as a full-time, remote Source Document Specialist! You will be responsible for creating, maintaining, and controlling accurate source documents for clinical trials, ensuring compliance with GCP guidelines and 21 CFR Part 11. This role involves working with e-Source and paper documents, collaborating with site staff and internal departments, and managing version control. You will need experience in clinical research, proficiency in e-Source design, and strong organizational and communication skills. A Bachelor's degree in a relevant field or equivalent experience is required. Care Access offers a comprehensive benefits package including paid time off, health insurance, retirement plan, and more.

Requirements

• Possess experience as a Clinical Research Coordinator with diverse and complex clinical trials
• Be skilled and proficient with e-Source build and design (e.g., CRIO/Clinical Conductor)
• Be skilled in creation and revision of paper source templates
• Have the ability to interpret clinical trial protocol and determine how to design complete and accurate source documents
• Be a self-motivated, task-oriented, detailed person who can work independently, prioritizing responsibilities and adhering to project deadlines
• Have the ability to create source documents in Excel
• Be willing to learn computerized programs used in creating eSource
• Possess good verbal and written communication skills, especially for the remote work environment, including editing, proofreading, and grammar skills
• Be highly organized
• Possess IT Skills including Word, Email and Direct Messaging, digital document maintenance, and expert level in Excel
• Have the ability to work well within a team
• Possess a Bachelor's degree in a relevant field (Life Sciences, Healthcare, or related discipline), or relevant experience

Responsibilities

• Create, maintain, and control accurate versions of source documents (eSource or paper) for each clinical trial to substantiate trial activities
• Ensure all source documents follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to Care Access Research internal SOP
• Create initial e-Source using all available protocol-specific documents (i.e., current IRB approved protocol, blank or annotated CRF, Sponsor provided templates/worksheets, or reference manuals) 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

Benefits

• PTO/vacation days, sick days, holidays
• 100% paid medical, dental, and vision insurance. 75% for dependents
• HSA plan
• Short-term disability, long-term disability, and life insurance
• Culture of growth and equality
• 401k retirement plan