Conduct on-site and remote visits, monitoring and assessment of clinical trial sites, ensuring adherence to study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements.
Perform source document verification (as applicable), data collection, and accurate recording of study data, ensuring data integrity and compliance.
Monitor subject safety, reporting adverse events, and ensuring appropriate follow-up actions are taken, as applicable.
Contribute to the preparation and coordination of study initiation, monitoring, and close-out activities.
Assist in the preparation and participation in regulatory inspections and audits as necessary.
Maintain proactive communication with clinical research staff at participating sites to support study execution.
Promptly address site-related issues and escalate to appropriate Prenosis personnel as needed.
Manage and maintain all essential regulatory and trial documents across all study phases: site qualification, study approval, site initiation, interim monitoring, and closeout.
Track and ensure compliance with required documentation timelines (e.g., training logs, IRB approvals, protocol updates, adverse event reporting (as applicable).
Assist in coordinating submissions with central IRB.
Monitor and document any changes in study personnel, IRB approvals, or protocol deviations.
Complete training of research staff on study-related procedures, workflows, and documentation practices.
Oversee site readiness and support the implementation of new processes or updates throughout the study.
Monitor training of new research staff throughout the duration of the study/trial.
Monitor site-level patient recruitment and sample collection rates in accordance with enrollment goals, as applicable.
Regularly report study status and site performance metrics to internal company leadership.
Continuously monitor patient recruitment and sample collection rates and performance in accordance with Clinical Research processes and SOPs.
Identify issues and collaborate with external and internal stakeholders to find solutions.

Requirements

Bachelor’s degree or equivalent combination of education, training, and experience
3+ years of experience in clinical research or clinical trial coordination
Experience in interventional and/or observational trials/studies
Exceptional organizational skills, attention to detail and ability to manage multiple priorities
Excellent interpersonal and communication skills; able to work collaboratively with site staff and internal teams
Comfortable working independently while collaborating in a cross-functional environment
Strong understanding of applicable clinical research regulatory requirements, (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, and FDA regulations) and clinical trial operations.
Experience with EHR systems (e.g. EPIC, Cerner), CTMS, eTMF and eISF platforms and data capture systems (preferred)
Problem-solving mindset; ability to navigate fast-paced environments (preferred)
Experience with biomarker studies and/or acute care clinical research (preferred)
Experience with AI-enable platforms and/or Software as a Medical Device studies (SaMD) (preferred)
Proficiency with Microsoft Office Suite and clinical trial management tools (preferred)

Benefits

Comprehensive Medical, dental, and vision coverage
401(k) with company match
Unlimited time off
Major opportunity for career development to make significant impact at an exciting growth-stage company
Collaborative and innovative work environment
Chance to make a real impact on patient care
Opportunity to work on cutting-edge AI technology in healthcare

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical trial coordinationsource document verificationdata collectiondata integrityregulatory compliancepatient recruitmentsample collectionbiomarker studiesSoftware as a Medical Device (SaMD)Good Clinical Practice (GCP)

Soft skills

organizational skillsattention to detailinterpersonal skillscommunication skillsproblem-solving mindsetability to manage multiple prioritiescollaborative workindependent workcross-functional collaborationability to navigate fast-paced environments