Operations - Source Specialist

Tribe513 | The Onyx Group•Greenville, SC

About The Position

The Source Specialist is responsible for developing, organizing, and maintaining source documentation for clinical trial visits in accordance with protocol requirements, regulatory guidelines, Good Clinical Practice (GCP), and sponsor expectations. This role ensures that study sites have clear, accurate, and compliant source materials to collect participant data consistently and correctly. A person in this position will be detail-oriented, knowledgeable in clinical workflows, and skilled at translating protocol requirements into practical, site-friendly templates and visit guides. This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties. Responsibilities, tasks, and duties of the job holder might differ from those outlined in the job description and other duties, as assigned, might be part of the job. A person in this position must be highly organized, utilize excellent verbal and written communication and be able to multi-task. This position requires excellent time management and communication skills and confidentiality. This position may require travel, lifting (up to 50 pounds), sitting, standing, and walking associated with a normal clinical research / physician office environment. A person in this position may be exposed to fumes, airborne particles, infectious diseases, blood/bodily fluids, and disease-bearing specimens. This position requires adherence to Tribe Clinical Research’s Core Values as outlined: We are passionate about working for a GROWTH ORIENTED company. We exhibit a HUMBLE but CONFIDENT approach to work. We communicate what needs to be said RESPECTFULLY. We love serving others and WORKING TOGETHER for the greater good. We can take constructive feedback well and have a POSITVE ATTITUDE even when the going gets tough.

Requirements

1-3 years of experience in clinical research, clinical operations, or documentation-focused research support role.
Familiarity with GCP, ICH guidelines and FDA regulations.
Produces accurate, compliant, audit‑ready documentation.
Works effectively with internal teams and external partners.
Identifies documentation gaps and proposes solutions.
Follows and improves documentation workflows.
Translates complex protocol elements into practical templates.
Proficiency in Microsoft Office (Word, Excel), Adobe, and electronic document management systems.
A person in this position must be highly organized, utilize excellent verbal and written communication and be able to multi-task.
This position requires excellent time management and communication skills and confidentiality.
This position may require travel, lifting (up to 50 pounds), sitting, standing, and walking associated with a normal clinical research / physician office environment.
A person in this position may be exposed to fumes, airborne particles, infectious diseases, blood/bodily fluids, and disease-bearing specimens.

Nice To Haves

Experience with source document creation, protocol interpretation, or monitoring preferred.

Responsibilities

Ensure source documents reflect all study-specific procedures, timing windows, safety assessments, labs and data collection points.
Maintain version control and track updates or amendments to source materials.
Review study protocols, amendments, lab manuals, pharmacy manuals, and sponsor guidance to ensure accurate reflection of all requirements.
Identify gaps, inconsistencies, or ambiguities in protocol documents that impact source creation and escalate for clarification.
Update templates promptly based on monitoring feedback, audits, or protocol amendments.
Work closely with CRC, Data Management, Monitoring teams, and sponsors to ensure usability and completeness of source tools.
Provide training or guidance to site staff on using the source documents effectively.
Respond to site queries related to source structure, version updates, or protocol interpretation.
Manage the life-cycle of source documents including creation, revision, approval, and distribution.
Upload finalized and approved source documents into the designated electronic filing system (CRIO).
Maintain tracking logs for versioning, distribution, and receipt by sites.
Create source templates and forms in CRIO in accordance with the Primary Investigator, Lead coordinator, and Lead QA
Publish source visits and forms from CRIO to give availability to applicable sites
PDF most current version and save to server for backup purposes.