Job Responsibilities
* 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.
* Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site‑specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
* Verifies informed consent has been adequately performed and documented for each subject/patient; demonstrates diligence in protecting the confidentiality of each subject/patient.
* 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.
* Assesses site processes and conducts source‑document review of appropriate site source documents and medical records, verifying required clinical data entered in the case report form (CRF) is accurate and complete.
* Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture; verifies site compliance with electronic data capture requirements.
* May perform investigational product (IP) inventory, reconciliation and reviews storage and security, and verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
* Reconciles contents of the Investigator Site File (ISF) with the Trial Master File (TMF) and ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
* Documents activities via confirmation letters, follow‑up letters, trip reports, communication logs and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan; supports subject/patient recruitment, retention and awareness strategies.
* For assigned activities, understands project scope, budgets, and timelines; manages site‑level activities/communication to ensure project objectives, deliverables and timelines are met.
* May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate; ensures all assigned sites and project‑specific site team members are trained and compliant with applicable requirements.
* Prepares for and attends investigator meetings and/or sponsor face‑to‑face meetings; participates in global clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements.
* Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow‑up actions.
* Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
Qualifications
* Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
* Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
* Previous monitoring experience in Austria.
* Must demonstrate good computer skills and be able to embrace new technologies.
* Fluency in German and English.
* Excellent communication, presentation and interpersonal skills.
* Ability to manage required travel.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Seniority level
* Mid‑Senior level
Employment type
* Part‑time
Job function
* Business Development and Sales
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