Job Description:

The base salary range for this position is $170,000 - $190,000.What you will be DoingResponsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:Coordinate site management activities:Site identification, recruitment, and selection.Regulatory document collection and review.Overall scheduling and management of all site visits.Develop sitemonitoring tools and training materials.Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.Coordinate and oversee daily operations of clinical monitoring team:Set and enforce project timelines with the assigned study team.Coordinate remote review of clinical data within EDC system.Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.Review and approve trip reports and follow-up letters within required timeframe.Manage quality and regulatory compliance among clinical monitoring team and investigational sites.Manage project milestones and proactively address deficienciesManage CRA performance:Define and implement functional standards, goals, and expectations with clinical monitoring team.Serve as CRA mentor and perform accompanied field assessment visits as required.Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.Documentation DutiesResponsibilities:Assure that the appropriate SOPs are followed.Ensure all project documentation is appropriately filed per SOPs.Assist PM in preparation of audit responses, as appropriate. Required ExperienceThorough knowledge of clinical research process.Strong communication skills (verbal and written) to express complex ideas.Excellent organizational and interpersonal skills.Ability to manage multiple priorities within various clinical trials.Ability to reason independently and recommend specific solutions in clinical settings.Understanding of basic data processing functions, including electronic data capture.Working knowledge of current ICH GCP guidelines and applicable regulations.Ability to work independently, prioritize and work with a matrix team environment is essential.Prior experience in electronic data capture (EDC) preferred.Able to mentor CRAs and more junior Clinical Trial Managers.BSBA (or equivalent) in one of the life sciences and a minimum of 4 years direct experience in clinical studiesMinimum of 4 years as a Clinical MonitorCRA, as well as experience in data handling or analysisMinimum of 5 years as a successful Lead CRA or Clinical Trial Manager.