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, provide recommendations regarding site‐specific actions, immediately communicate/escalate serious issues to the project team, and develop action plans.
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate, and demonstrates diligence in protecting the confidentiality of each subject/patient.
Assesses factors that might affect subject/patient safety and clinical data integrity at an investigator/physician site, such as protocol deviations/violations and pharmacovigilance issues.
Per the Clinical Monitoring/Site Management Plan (CMP/SMP), assesses site processes, conducts source document review of appropriate site source documents and medical records, and verifies required clinical data entered in the case report form (CRF) is accurate and complete.
Applies query resolution techniques remotely and on site, provides guidance to site staff as necessary, and drives 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, verifies site compliance with electronic data capture requirements, and may perform investigational product (IP) inventory, reconciliation, and reviews of storage and security.
Verifies that the IP has been dispensed and administered to subjects/patients according to the protocol, verifies issues or risks associated with blinded or randomized information related to IP, and applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released/returned.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness, reconciles contents of the 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, enters data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
For assigned activities, understands project scope, budgets, and timelines; manages site‐level activities/communication to ensure project objectives, deliverables, and timelines are met; and 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, and participates in global clinical monitoring/project staff meetings.
Provides guidance at the site and project level towards audit readiness standards, supports preparation for audit and required follow‐up actions, maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, and completes assigned training as required.
Additional Responsibilities (Real World Late Phase) Site support throughout the study lifecycle from site identification through close‐out.
Knowledge of local requirements for real world late phase study designs and chart abstraction activities and data collection.
Collaboration with Sponsor affiliates, medical science liaisons, and local country staff.
May be requested to train junior staff, identify and communicate out‐of‐scope activities to Lead CRA/Project Manager, and proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy, and Health Care Provider (HCP) associations.
Qualifications Bachelor's degree or RN in a related field or an equivalent combination of education, training, and experience.
+1 year experience as an independent on‐site monitor.
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
Demonstrates good computer skills and embraces new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage required travel of up to 75% on a regular basis.
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, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Compliance With Equal Opportunity and Disability Laws : 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. This compliance extends to all legislation of each country in which the Company operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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