|募集職種||外資製薬メーカーにて CRAトレーニング！Senior Clinical Research Associate (Trainig Specialist） の求人（15299）
|求人要件||・For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving startup, execution, and closeout. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports. Anticipate and identify site issues that could affect timelines and develop alternative solutions.
・Ensure clinical trial management systems containing all sitespecific information are maintained and kept current. Provide Local regulatory and legal requirement expertise. Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
・Ensure 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. Stay abreast of new and/or evolving local regulations, guidelines and policies.
・Ensure audit and inspection readiness of assigned sites. Advise on preaudit activities for GCP requirements. Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
・Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work.
・Liaise and coordinate with Site M&M personnel (Country and Line Managers), functional SME’s (including GCT, Country, and affiliate functions where relevant) supporting the training and on boarding to;
・Share/collect local trainings and initiatives that are available.
・Identify best practice, and standardize onboarding and training program and materials across countries and regions
・Utilize and incorporate existing local and global documents and tools, e.g. new hire training agenda, CRA Mentor
・Develop training plans for all-monitoring roles.
・Provide guidance to line managers on which aspects should be delivered via classroom training vs. on-site training.
・Identify SME’s and ensure that relevant trainings on new initiatives and activities are regularly incorporated into the training plans and training is delivered for the countries/region for which they are responsible for in a manner that is relevant, equitable, and meets the needs of the Site M&M monitors
・Utilize Development University resources for on-line training and on-boarding. Ensure that training plans and optimised materials / tools are housed in Development University, and drive awareness / utilisation of Development University as the online repository for CFO.
・Ensure delivery of training for Monitors by;
・Working with SME’s and trainers, including GCT to facilitate and coordinating training delivery for country(ies) and region.
・Work with Country Heads, Line, and Functional Managers, to incorporate timely periodic, targeted training (e.g., for PSE and STV requirements) so that these sessions can be completed close to performing these tasks. This should also include the Essential Document requirements from early site identification (CIQ, Transcelerate Profile form etc), through to STV and during study
・Consolidate lessons learned across other areas (e.g., quarterly forums, including CAPA’s etc.) and ensure that these are incorporated into the Monitor training curriculum.
・Work with Initiative and task force teams to ensure that new processes and tools (e., risk-based monitoring), are pro-actively incorporated into training plans. Ensure that Monitors are informed , trained, and updated in advance of when these are needed by working with the SME’s and trainers for these topics to deliver appropriate training for their country(ies) or region.
・Subject to resource availability, may conduct accompanied sites visits with the newly-hired CRAs if a need is identified to assist a country if limited line management personnel or experienced monitoring staff are available.
・Develop and Enhance relationships with other Development Operations functions , particularly GCT, to generate, coordinate, streamline, and consolidate training and/or training materials as applicable.
・Generate targeted training materials for countries (as applicable) and include regional or country considerations or specific requirements
・May act as consultant to Initiatives and Task groups to provide feedback on proposed training materials.