Kendle International Inc. Work Values

Daily Duties at Kendle International Inc.:

• Provided leadership and clinical/technical support to administrative and clinical research staff in monitoring project activities for Phase I-IV clinical pharmaceutical research studies across 14 sites, applying knowledge of Good Clinical Practices (GCP) and relevant regulatory requirements (including the Federal Food, Drug, and Cosmetic Act). • Prepared and developed policy and procedural materials. • Created the Site Study Manual for each site for a Muscular Dystrophy study and assisted in the creation of all Case Report Forms to be used in the study. • Assisted a sponsor in study start up by preparing the site procedure manual with guidelines and examples of all procedures to be used during the study. • Assisted in the preparation of the monitoring guidelines to be used by all monitors on the study and what to review, complete and submit for each monitoring visit. • Managed study site activities to ensure the integrity of clinical data through adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs)/Project Specific Operating Procedures (PSOPs). • Providing direction and guidance to project team, coordinating all monitoring activities and communicating activity status to the Project Leader. • Primary client contact for project activities. Initiated innovative patient enrollment strategies with the project team and study sites. Developed and implemented innovative approaches for preparing and coordinating investigator meetings. • Submitted required documents to Ethics Committees. Liaison between clinical monitoring and other functional departments. Provided status updates to Project Leader from pre-study through closing. • Mentored CRA and administrative staff and conducted co-monitoring/training visits. • Developed innovative approaches to identifying and evaluating potential investigators. Evaluated study sites with senior staff, ensured site registration in investigator database, and wrote site evaluation reports for Project Leader. Identified potential study impediments and implemented corrective actions. Participated in feasibility activities and reported outcome to appropriate manager. • Identified and communicated CRA performance issues to the appropriate administrative Project Leader. • Performed clinical trial initiation, monitoring, and close-out activities while adhering to applicable regulatory procedures, SOPs and PSOPs. Completed initiation visits with study site staff that included training, reviewing regulatory requirements, collecting outstanding documents, reviewing patient screening/randomization procedures, reviewing Serious Adverse Events (SAEs) reporting requirements, and reviewing drug storage and accountability procedures. Assisted with protocol review, Case Report Form (CRF) and Informed Consent (ICF) development. • Created study monitoring plan and led CRA team in annotating CRFs, study procedures and the study reference manual. Monitored and tracked study progress for all CRAs and individual sites.

What they like about Kendle International Inc.:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

Leader, Instructor, Mentor, Training Specialist, Manager, Team Oriented

Skills

P&L responsibilities, Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts., Technology Solutions, Sales Support, Software Implementation, Requirements Analysis & Specification, Leadership

These are some of the questions we asked our climbers about their experiences with Kendle International Inc.: