- Purpose :
To enable **** emergence as a world class R&D organization, the position anticipates and proactively solves studyｭrelated clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol level execution of SMM deliverables involving startｭup, execution, and closeｭout of studies.
・Monitors activities conducted by clinical investigative sites as they relate to **** clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, **** Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
・Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and **** Standard Operating Procedures (SOPs) and business processes.
・Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites.
・Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and followｭup for all safety events by site personnel.
・Ensures safety and protection of study subjects through compliance with the study monitoring plan, **** SOPs, ICH Guidelines, and applicable regulations.
・Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
・Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines.
・Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal**** requests to assist in the placement of planned clinical studies with qualified investigators.
- ・Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
・Minimum of 1 year of clinicallyｭrelated experience, of which a period of 6 months is preferable in clinical research monitoring. Experience in onｭsite monitoring of investigational drug or device trials is required
・Current inｭdepth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
・Current inｭdepth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
・Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.
・Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.
・Demonstrated business ethics and integrity.