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Care Access

Source Document Specialist

OR · Remote

$30 - $35/hr

Review and validate source documents (eSource and paper) to ensure completeness, accuracy, and alignment with study protocols, while ensuring compliance with GCP, 21 CFR Part 11, and internal SOPs.

Gonzalez MD and Aswad MD Health

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Salesforce Architect

Miami, FL · Remote

$100 - $200/day

Integrate Salesforce with systems such as CTMS, EDC, eSource, eConsent, ePRO/eCOA, EMR/EHR, labs, payment systems, document systems, or external databases.Support data migration, data cleanup ...

Care Access

Source Document Specialist

Review and validate source documents (eSource and paper) to ensure completeness, accuracy, and alignment with study protocols, while ensuring compliance with GCP, 21 CFR Part 11, and internal SOPs.

Crio, Inc.

Engineering Manager

CRIO is a leading provider of eSource solutions for clinical research. Our platform streamlines clinical data collection and management, ensuring protocol compliance and reducing errors. By ...

Crio, Inc.

Software QA Engineer II

$75K - $85K/yr

CRIO's eSource and CTMS system is a leading, modern, enterprise platform built for clinical research sites. Since CRIO's launch in 2016, CRIO has established the leading brand position in eSource and ...

Care Access

Source Document Specialist

Boston, MA

Review and validate source documents (eSource and paper) to ensure completeness, accuracy, and alignment with study protocols, while ensuring compliance with GCP, 21 CFR Part 11, and internal SOPs.

Crio, Inc.

Product Owner

$100K - $130K/yr

CRIO's eSource and CTMS system is a leading, modern, enterprise platform built for clinical research sites. Since CRIO's launch in 2016, CRIO has established the leading brand position in eSource and ...

Irvine Clinical Research

Site Manager

Inglewood, CA · On-site

$100K - $120K/yr

Maintain data integrity and quality across all electronic systems (eSource, EDC, CTMS). Own the successful completion of regulatory requirements and sponsor monitoring visits. * Strategic ...

Frontage Laboratories

Medical Assistant

Secaucus, NJ · On-site

$20 - $24/hr

Develops proficiency in the use of in-house eSource system (Clinspark). * Assist Clinical Research Coordinators in any task as needed including, labeling, taping (e.g., sample collection and transfer ...

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Esource information

What are the main responsibilities of an Esource Specialist in a clinical research setting?

As an Esource Specialist, your primary responsibilities include implementing and maintaining electronic source data systems for clinical studies, ensuring data accuracy, and supporting compliance with regulatory standards. You will often work closely with clinical research coordinators, data managers, and IT teams to set up, test, and troubleshoot eSource platforms. Additionally, you may assist in training site staff, creating documentation, and participating in data quality audits. This role is a key part of the clinical research process, helping streamline workflows and contribute to the reliability of study outcomes.

What is an Esource job?

An Esource job typically involves managing electronic source data in clinical research or healthcare settings. Professionals in this role ensure the accurate collection, storage, and integration of digital records, often replacing traditional paper documentation. They may work with electronic data capture (EDC) systems, regulatory compliance, and data quality control. Strong attention to detail and familiarity with clinical or regulatory environments are essential.

What are the key skills and qualifications needed to thrive in the Esource position, and why are they important?

To succeed as an Esource Specialist, you need a background in clinical research, an understanding of data management, and familiarity with regulatory guidelines, often supported by a degree in life sciences or a related field. Expertise in electronic data capture (EDC) systems, eSource platforms such as Medidata Rave or OpenClinica, and possibly certifications in clinical data management are highly valued. Attention to detail, problem-solving ability, and strong collaboration skills are essential for working with research teams and ensuring data integrity. These competencies are vital to ensure accurate, compliant, and efficient collection and management of clinical trial data.

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Esource jobs near you
Infographic showing various Esource job openings in the United States as of July 2026, with employment types broken down into 1% Internship, 86% Full Time, 6% Part Time, and 7% Contract. Highlights an 70% Physical, and 30% Remote job distribution.
Source Document Specialist

Source Document Specialist

Care Access

OR • Remote

$30 - $35/hr

Other

Medical, Dental, Vision, Retirement, PTO

Re-posted 27 days ago

Job description

How This Role Makes a Difference

The Source Document Specialist is responsible for ensuring accurate, compliant, and efficient clinical trial documentation. This role translates complex study protocols into clear, structured source documents that support highquality data collection and regulatory compliance. Serving as a key partner to site staff and study teams, the Specialist manages version control, improves documentation workflows, and safeguards data integrity.

How You'll Make An Impact
  • Review and validate source documents (eSource and paper) to ensure completeness, accuracy, and alignment with study protocols, while ensuring compliance with GCP, 21 CFR Part 11, and internal SOPs.
  • Review protocol amendments and other study changes to assess impact on source documents, communicate required updates to the source team, and submit revisions as needed.    
  • Coordinating with source creators, site staff and internal teams for feedback and approval.     
  • Manage daily communication with site staff, study teams, and internal departments regarding source document updates, requests, and training support. 
  • 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
  • Provide feedback to help update standardized templates and checklists to improve the efficiency of source document review.
The Expertise Required
  • The Source Document Specialist must demonstrate a strong understanding of clinical trial protocols, GCP, and applicable regulatory requirements, including 21 CFR Part 11, to ensure compliant source documentation. Prior experience in clinical trials-particularly in a Clinical Research Coordinator (CRC) or Quality Assurance (QA) or similar role-is preferred and provides valuable insight into study workflows and data collection needs.
  • The role requires proficiency in Microsoft Excel, Word, Outlook, Teams, and SharePoint, along with the ability and willingness to work within eSource platforms such as CRIO. Strong attention to detail is essential to identify discrepancies, manage version control, and ensure accuracy and traceability of source documentation.
  • Successful candidates will demonstrate excellent organizational skills, the ability to prioritize tasks in a fastpaced environment, and effective communication skills for collaborating with site staff, study teams, and regulatory stakeholders. Strong analytical and problem-solving skills, with the ability to interpret complex study requirements are critical to success in this role. A solutionoriented mindset and the ability to assess and improve documentation workflows are equally important. The position requires comfort working both independently and as part of a global team, managing multiple systems, and adapting to evolving research and technology needs.
  • Fluency in English (reading, writing, and speaking) is required to communicate effectively with the global Source team and to review Englishlanguage protocols, manuals, and regulatory documentation.
Certifications/Licenses, Education, and Experience
  • Minimum Education:
    • 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 Experience:
    • 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.
  • Certified Clinical Research Coordinator (CCRC) - from ACRP (Association of Clinical Research Professionals)
  • Certified Clinical Research Professional (CCRP) - from SOCRA (Society of Clinical Research Associates)
  • Good Clinical Practice (GCP) Certification - required or obtained upon hire. 
How We Work Together
  • Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
  • Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
  • Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.

The expected pay range for this role is $30.00 - $35.00 USD per hour for full time team members.

Benefits & Perks (US Full Time Employees)
  • 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 

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