The Site Systems Coordinator serves as an operational liaison between study system configuration and clinical execution to ensure eSource builds align with site workflows. They are responsible for reviewing methods, edit checks, and processing pathways while identifying operational risks and maintaining audit readiness.
Requirements summary
Candidates must possess a university degree in a scientific discipline with at least 2 years of experience in clinical research, or a minimum of 5 years of direct clinical research site experience. Proficiency in Excel, EDC systems, and a strong understanding of site workflows and regulatory requirements are essential.
Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Stage Clinical and Phase I IV Clinical Research services.
We welcome individuals who want to be part of our growing organization.
QPS is an innovative, dynamic organization that strives to employ talented, caring and committed employees who will work collaboratively towards achieving our mission of improving human health and the quality of life.
QPS offers challenging and rewarding work in its four core business areas and support functions.
Underpinning the operation is a culture that values diversity, innovation and accountability.
Employees are encouraged to take responsibility and achieve their best, both as individuals and as team members.
Description
The Site Systems Coordinator (SSC) supports clinical research site operations by serving as the operational liaison between study system configuration and clinical execution. This role ensures that ClinSpark (eSource) builds are aligned with real-world site workflows prior to team structured review, reducing operational burden while maintaining clear build ownership and compliance boundaries.
The SSC does not configure study systems or approve builds, but provides structured, workflow-focused review and documentation to support efficient and accurate study execution
Responsibilities
Within QPS ClinSpark test environment, responsible for review of methods, edit checks and deviation windows utilized for each study, ensuring appropriate method check is aligned per protocol and deviation windows and edit checks are accurately firing as intended.
Identify potential operational risks, inefficiencies, or burden prior to formal review
Initiate processing pathways throughout finalization of protocol and applicable manuals, notification to operations once complete
Review ClinSpark specimen collection forms to ensure applicable lab panel and processing pathways are accurately connected to the forms
Prepare structured review summaries and guidance
Translate system logic and configuration into operationally relevant language
Serve as a first point of contact for questions related to system workflow (non-ClinSpark build related)
Notification to operations upon completion of the draft LTL, processing pathways and overall indication of lab panels and processing pathways being complete
Maintain operational issue logs, review notes, and resolution documentation
Maintain operational documentation to support inspection and audit readiness
Adhere to site SOPs, GCP, and applicable regulatory requirements
Qualifications
Combination of relevant education & experience provides sufficient knowledge & skills to ensure incumbent’s success in this role, such as:
University/College Degree in relevant Scientific discipline, and
2 years demonstrated experience in CRO, Clinical Research, or another relevant field.
Or
Minimum of 5 years of direct clinical research site experience, preferably as a CRC
Experience in a Regulated industry preferred
Working knowledge of eSource and clinical trial management systems (ClinSpark experience preferred)
Strong understanding of site workflows and visit execution
Excellent written and verbal communication skills
Highly proficient in Excel with advanced knowledge of EDC systems
QPS is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. QPS prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. QPS conforms to the spirit as well as to the letter of all applicable laws and regulations.
