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Adams Clinical

eSource Architect

Posted 12 Days Ago
Be an Early Applicant
Remote
Hiring Remotely in United States
60K-65K Annually
Junior
Remote
Hiring Remotely in United States
60K-65K Annually
Junior
Develops, maintains, and quality-controls eSource documentation across clinical research sites. Builds and updates electronic source documents, standardizes workflows, supports study start-up, verifies eSource before first patient visits, and ensures audit-ready compliance with ICH-GCP, FDA, IRB, sponsor, and CRO requirements. Collaborates with quality assurance, regulatory, operations, and finance teams while managing multiple protocols and site requests.
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Join Us in Shaping the Future of Clinical Research 

Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromising data quality, safety, and diverse enrollment to advance healthcare. Our vision is to set the gold standard for clinical trial excellence. We believe our people make the difference. Guided by our core values—Scientific Rigor, Operational Excellence, Commitment to Sponsors and Participants, and Authentic Collaboration—we create an environment where meaningful work drives meaningful change. 

At Adams Clinical, you’ll find: 

  • A culture of respect, transparency, and continuous improvement 
  • Opportunities for professional growth and learning 
  • A team dedicated to improving lives through innovation and integrity 

If you’re passionate about making an impact in clinical research and want to be part of a collaborative, mission-driven organization, we’d love to have you on our team. 

Job Role 

Adams Clinical is seeking a detail-oriented and proactive eSource Architect to oversee the development, maintenance, and quality control of electronic source (eSource) documentation across our multi-site research network. This role plays a critical function in ensuring that source documentation is accurate, compliant, and operationally ready in alignment with ICH-GCP, FDA, and IRB requirements. 

The eSource Architect reports directly to the Associate Director of Quality Assurance and works closely with the Regulatory, Operations, and Finance teams to support both study start-up activities and the day-to-day management of source amendment requests. The successful candidate will balance efficiency and compliance, ensuring that eSource is finalized ahead of trial activation and that amendment requests are processed rapidly with precision. 

A central focus of this role is to optimize eSource design and workflows so that site clinical research staff can execute study protocols seamlessly, thereby reducing protocol deviations, improving protocol and regulatory compliance, and trial efficiency. 

Key Responsibilities: 

  • Develop new source builds across all active and start-up studies within the site network, finalized in advance of site activation to ensure enrollment readiness. 
  • Review and implement protocol amendment updates promptly, minimizing operational delays while safeguarding regulatory and protocol compliance. 
  • Review and implement site-requested updates promptly. 
  • Drive standardization of the eSource build for data extraction, optimizing eSource systems to establish a cohesive platform that enables CRCs to execute protocol-required procedures consistently and accurately. 
  • Drive the eSource verification process with the quality and finance teams prior to first patient, first visit across trials. 
  • Maintain audit-ready, compliant source documentation aligned with sponsor, CRO, and regulatory expectations.   

Job Requirements: 

  • Minimum of 2 years of clinical research experience (e.g., Clinical Research Coordinator, Regulatory Coordinator, or similar). 
  • Demonstrated experience with source/eSource creation and/or electronic data capture platforms (e.g., ClinicalResearch.io, Medidata Rave, or similar) preferred. 
  • Strong knowledge of ICH-GCP, FDA regulations, and IRB requirements along with familiarity with sponsor/CRO expectations for regulatory documentation and source data verification. 
  • Bachelor’s degree in a scientific, health-related, or administrative field (or equivalent work experience). 
  • Exceptional organizational skills with the ability to manage competing priorities across multiple protocols and sites. 
  • Proven ability to meet strict timelines while maintaining accuracy and compliance in a fast-paced, deadline-driven environment. 
  • Strong written and verbal communication skills; ability to collaborate across multidisciplinary teams. 
  • Experience building eSource through Clinical Research.io (CRIO) is a plus. 

Pay: $60-65k salary, commensurate with experience 

Benefits:
  • 401(k) matching
  •  Medical, Dental, & Vision insurance
  •  Employee assistance program
  •  Flexible spending account
  •  Health insurance
  •  Health savings account
  •  Life insurance
  •  Paid time off
  •  Parental leave
  •  Professional development assistance

Adams Clinical is committed to being an equal opportunity and affirmative action employer. We focus on hiring and nurturing top talent. All employment decisions, including recruitment, hiring, promotion, compensation, transfer, training, discipline, and termination, are made based on the candidate’s or employee’s qualifications relevant to the position. These decisions are made without regard to age, sex, sexual orientation, gender identity or expression, genetic information, race, color, creed, religion, ethnicity, national origin, citizenship, disability, marital status, military status, pregnancy, or any other legally protected status. 

In compliance with federal law, all individuals hired must, as a condition of employment, provide documentation verifying their identity and authorization to work in the United States and complete Form I-9 within the required time frame. Adams Clinical participates in E-Verify to confirm employment eligibility. 

HQ

Adams Clinical Watertown, Massachusetts, USA Office

521 Mount Auburn St, Watertown, Massachusetts, United States, 02472 4153

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