Source Document Specialist

Job not on LinkedIn

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

CARE

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1945

⚕️ Healthcare Insurance

📚 Education

🎯 Recruiter

💰 Grant on 2021-11

Healthcare Insurance • Education • Recruitment

CARE is a boutique provider of high-quality, accredited carers for the Aged Care and Early Learning industries. It specializes in matching experienced professionals, recent graduates, and students with job vacancies in these sectors, facilitating rewarding career placements. CARE aims to support clients and carers by providing effective staffing solutions and contributing to their success in the industry.

📋 Description

• Prepare and develop accurate source documents (eSource and paper) based on clinical trial protocols, ensuring compliance with GCP, 21 CFR Part 11, and internal SOPs. • Review and validate source documents to ensure completeness, accuracy, and alignment with study protocols, coordinating with site staff and internal teams for feedback and approval. • Maintain version control, track document updates, and implement protocol amendments efficiently while ensuring compliance with regulatory requirements. • Manage daily communication with site staff, study teams, and internal departments regarding source document updates, requests, and training support. • Organize, file, distribute, and archive source documents systematically for each clinical trial, ensuring proper documentation and accessibility. • Support quarterly initiatives, including process improvements, training development, and workflow optimizations for source documentation. • Participate in cross-functional meetings to provide input on study start-up timelines, protocol changes, and documentation impact analysis. • Conduct internal audits and quality checks to ensure adherence to documentation standards and regulatory compliance. • Develop and update standardized templates and checklists to improve the efficiency of source document creation.

🎯 Requirements

• Bachelor’s degree in a health-related field (e.g., Life Sciences, Nursing, Public Health, or a related discipline) preferred. Equivalent work experience in clinical research may be considered. • Minimum of 2 years of experience in clinical research, with preferred experience as a Clinical Research Coordinator (CRC) or in a role involving source documentation, study execution, or regulatory compliance. • Strong knowledge of clinical trial operations, including protocol interpretation, source creation, and site workflow processes. • Experience working with Good Clinical Practice (GCP) guidelines, 21 CFR Part 11 compliance, and clinical trial documentation standards. • Microsoft Excel, Word, SharePoint, and other digital documentation tools.

🏖️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays • Medical, dental, and vision insurance plan options