Site Systems Coordinator

Job Description

Job Description

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

EEO Minorities/Females/Protected Veterans/Disabled

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.