Essential Functions : 1.Monitoring
Plans and conducts study initiation visits for investigatorsites. Applies planning techniques for monitoring visits to ensure efficientand effective monitoring.
Plans and conducts study close-out visits forinvestigator sites. Manages and prioritizes workload effectively.
Maintains awareness ofkey study performance indicators for own sites. Supports subject recruitmentand retention strategies.
Updates study and subject status information.Documents and tracks the resolution of all outstanding site-specificprotocol-
related issues from contact to contact and anticipates / identifiespotential issues and implements corrective actions. Seeks guidance to resolvecomplex issues.
Serious Adverse Event (SAE) reporting requirements,Investigational Product (IP) management, bio sample management and subjectreported outcomes instruments as applicable.
Follows standard process fordocumentation of site contacts (visits, phone, email etc.).
2.SubjectRights & Wellbeing Verifies process of obtaining informed consent has beenadequately performed and documented for each subject.
Demonstrates diligence inprotecting the confidentiality of each subject. Assesses factors that mightaffect subject’s safety and clinical data integrity at an investigator sitesuch as protocol deviation / violations and pharmacovigilance issues.
4.DataManagement Uses analytical thinking to review data recorded in source documentsfor accuracy and completeness and in accordance with the clinical monitoringand associated plans.
Verifies clinical data entered in the case report form(CRF) is accurate and complete. Applies query resolution techniques remotelyand on site and provides guidance to site staff as necessary, driving queryresolution to closure within agreed timelines.
Utilizes available hardware and software to support the effectiveconduct of the clinical study data review and capture.Performs these tasks routinely andindependently, seeking guidance as needed.
5.InvestigationalProduct Performs IP inventory, reconciliation and reviews storage and security.Verifies the IP has been dispensed and administered to subjects according tothe protocol.
Verifies process and identifies any issues or risks associatedwith blinded or randomized information related to IP. Applies knowledge ofGCP / local regulations and organizational procedures to ensure IP isappropriately (re)labelled, imported and released / returned.
6.Documentationand Record keeping Routinely reviews the Investigator Site File (ISF) foraccuracy, timeliness and completeness.
Reconciles contents of the ISF with thetrial master file (TMF). Ensures investigator site is aware of requirement ofarchiving essential documents in accordance with the local guidelines andregulations.
Verifies site compliance with requirements for electronic datacapture. Performs these tasks routinely and independently seeking guidance asneeded.
7.Communication Maintainseffective, accurate, and timely communication with site staff and project team,ensures appropriate issue escalation.
Seeks guidance to resolve more complextasks. Uses the appropriate mode of communication in relaying information.Participates in global conference calls and meetings to review progress ofongoing clinical trials.
8.Prepares for and attends Investigator Meetingsand / or sponsor face to face meetings.
9.Attends clinical monitoring / project staff meetingsand attends clinical training sessions according to the project specificrequirements.
1.Maintains required functional and job specifictraining.
2.Performs other work-related duties as assigned.
3.Asa representative of the Company, demonstrates professional attire, attitude andbehavior in meetings & teleconferences, site visits and interactions, andinterpersonal activities in general.
Model professional communication in both written andverbal interactions.
Tasks, duties, and responsibilities as listed in this jobdescription are not exhaustive. TheCompany, at its sole discretion and with no prior notice, may assign othertasks, duties, and job responsibilities.
Equivalent experience, skills, and / or education will also be consideredso qualifications of incumbents may differ from those listed in the JobDescription.
The Company, at its solediscretion, will determine what constitutes as equivalent to the qualificationsdescribed above. Further,nothing contained herein should be construed to create an employmentcontract.
Occasionally, requiredskills / experiences for jobs are expressed in brief terms. Any language contained herein is intended tofully comply with all obligations imposed by the legislation of each country inwhich it operates, including the implementation of the EU Equality Directive,in relation to the recruitment and employment of its employees.