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Job #03061

About our client Our client is the clinical trial services division of a leading academic institution that has developed a reputation for developing some of the most advanced medical research in the world. The company has an experienced management team and employee base that is committed to the highest standards of integrity and to improving the lives of patients and their families. This is a strong opportunity for someone that wants to put their drive and initiative to work. Position Location Lead Clinical Research Associate North Carolina Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage the development, coordination and implementation of clinical operations site management and clinical monitoring tasks for assigned projects (with guidance) 2) Oversee trial-specific processes and systems 3) Conduct daily supervision of the Clinical Operations Team for site management and clinical monitoring in accordance with contractual agreements, department guidelines, SOPs, applicable international, federal and state regulations and ICH guidelines 4) Provide leadership for the Clinical Operations Project Team for site management working (in close collaboration with the Project Leader and other functional group leaders) 5) Execute all monitoring services as per project-specific scope of work 6) Define, assign, coordinate, oversee and assess utilization and productivity of the Monitoring Team 7) Coordinate and supervise site monitoring assignments as well as activities 8) Direct and prioritize team efforts and assess overall team progress against study timelines and metrics 9) Develop performance standards for Project Team 10) Identify and notify appropriate parties of emerging out of scope activities 11) Evaluate impact on resource needs, study processes and related documents 12) Manage the development and maintenance of clinical trial documents, processes as well as systems according to trial-specific scope of work and budget (with minimal guidance) 13) Participate in the development of protocol, protocol revisions and amendments, monitoring plan, scope of work as well as operations manual with guidance 14) Coordinate the development, use and maintenance of study-specific processes, related documents, templates as well as monitoring and regulatory tools 15) Define site selection and activation 16) Train and supervise the team on trial-specific collection, review and approval of clinical trial documents as well as associated processes 17) Observe consistency in the conduct of the study and data collection according to the protocol and study objectives 18) Serve as key site management trial-team member to internal and external partners 19) Collaborate with internal and external partners to develop trial-specific tools and processes 20) Provide inputs regarding the development of CRF design and completion instructions, site materials, query rules and resolution process as well as related data tools and status reports 21) Review and analyze site payments and associated site status against Clinical Operations budget 22) Identify and oversee trial-related training and performance concerns of Monitoring Team 23) Maintain awareness of the level of performance and training needs 24) Provide ongoing input for development of individual training plan 25) Coordinate and oversee trial-specific training for CRAs (therapeutic in-service, reference materials, Investigator meeting, team monitor training, on-site co-monitoring and training visits) 26) Assist with all aspects of performance management (compiling and providing feedback for team members' annual performance evaluations) 27) Supervise and manage monitoring trial-team members' adherence to company and sponsor-specific administrative policies (with guidance) 28) Review and approve trial-related expense reports, timesheets as well as time-off requests 29) Assist in developing, implementing and revising processes, SOPs and standard forms 30) Support the company’s mission, departmental goals and organizational activities Requirements 1) Degree (4 year) in Clinical, Health or Life Science 2) Registered Nurse, Nurse Practitioner, Physician's Assistant, Pharmacist preferred 3) 4 – 5 years of related clinical research experience (3 years of directly related CRA experience or clinical trial management experience or equivalent combination of education and experience) 4) Experience in managing local and remote team of monitors 5) Experience in being a lead and mentor 6) Experience in streamline monitoring on large trials or in managing trial monitoring across multiple projects 7) Experience in developing action plans as well as identifying, communicating and resolving issues during visits 8) Experience in resolving performance issues with staff 9) Experience in working with large budgets and aggressive timelines 10) Experience in working with more than 2 sponsors/multi partners 11) Excellent communication skills (written and verbal) 12) Superb multitasking skills and ability to manage priorities across changing situations 13) Track record of setting up efficient operations for monitoring (i.e. trip report review, trip scheduling, etc.) 14) Knowledge of CV and/or international experience a plus 15) Politically savvy and mature individual