Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site.
Conducts Source Document Review of appropriate site source documents and medical records.
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
Senior Clinical Trial Associate responsible for managing clinical trial activities, documentation, vendor coordination, and ensuring compliance with GCP and regulatory requirements.
Responsibilities
Independently manage assigned clinical trial activities and operational workstreams in compliance with study protocols, SOPs, GCP, and applicable regulations.
Oversee collection, review, filing, and reconciliation of essential study documentation, ensuring Trial Master File (TMF) completeness and inspection readiness.
Manage preparation, maintenance, and reconciliation of Investigator Site Files (ISFs).
Develop and maintain study trackers, timelines, and metrics to monitor enrollment, site activities, milestones, and deliverables.
Independently manage assigned vendors and workstreams, including central laboratory activities, study supplies, and vendor deliverables.
Experienced Clinical Research Associate responsible for site qualification, initiation, monitoring, and close‑out activities across the Netherlands, utilizing GCP and electronic data capture systems.
Responsibilities
Perform site qualification, initiation, interim monitoring, and close‑out visits
Evaluate site performance and provide recommendations
Communicate and resolve serious issues with project team
Maintain knowledge of ICH/GCP guidelines and company SOPs
Verify informed consent procedures and data integrity
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
Assesses site processes, conducts source document review, verifies required clinical data entered in the case report form (CRF) is accurate and complete.
Applies query resolution techniques remotely and on site, driving query resolution to closure within agreed timelines.
Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
Responsible for the successful planning, implementation and execution of contracted activities for clinical trials, ensuring accurate transfer of contracts and compliance with Good Clinical Practices.
Compensation
The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00.
Responsibilities
Manages projects of full scope regional and global projects
Responsible for project team leadership
Building and maintaining positive client relationships
Negotiating with clients to assure IQVIA Biotech’s operational processes are maintained and projects are done within scope
Reviewing and identifying project study trends and proactively responding to client and team members
Requirements
Nursing degree
University degree US Bachelor Level or equivalent) in a health-related field
Nice to have: Experience managing people within a scientific/clinical environment
Senior Clinical Research Associate responsible for monitoring oncology and multi‑specialty clinical trials across the United States, with significant travel and remote work components.
Compensation
Target Pay Range: $110-$118K based on title
Responsibilities
Conduct routine and close‑out monitoring of clinical sites
Maintain study files and ensure protocol compliance
Perform CRF review, query generation and resolution
Report serious adverse events and produce narratives
Assist in training new employees and co‑monitoring
Requirements
University or college degree, or certification in a related allied health profession
Intermediate Clinical Research Nurse (CRN) advocates for patient safety and protocol integrity, adheres to patient care standards, and communicates effectively to ensure effective conduct of clinical trials and quality patient care.
Responsibilities
Advocates for patient safety and protocol integrity
Adheres to patient care standards
Communicates effectively to ensure effective conduct of clinical trials
Clinical Research Associate I responsible for site qualification, initiation, monitoring, and close‑out activities, ensuring compliance with GCP and regulatory requirements.
Responsibilities
Performs site qualification, site initiation, interim monitoring, site management and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Conducts Source Document Review of appropriate site source documents and medical records.
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
Requirements
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Clinical Research Associate (CRA) responsible for site qualification, monitoring, management, and close-out visits ensuring compliance with ICH-GCP and protocol standards.
Locations (2)
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Responsibilities
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits
Ensure regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
Evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions
Communicate/escalate serious issues to the project team and develop action plans
Verify the process of obtaining informed consent has been adequately performed and documented
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