Site Director - Clinical Research

Rockville, MD
Jun 17, 2019
Jun 19, 2019
Full Time
We are looking for a Site Director to work for a reputable Research Site Management Organization in Norfolk, NE. More details are listed below! Please apply if interested.SUMMARYThe primary task of a Site Director ("Director") is to manage all aspects of the clinical research program of the site. The Director must be able to manage multiple trials and perform all tasks to execute, manage, and coordinate research protocols, recruit subjects, data collection and operations of several concurrent clinical research studies. The Director will coordinate with the Prinicipal Investigator(s) and Sub Investigator(s) to integrate their research tasks with the clinical schedule. Working under the direction of the Principal Investigator, develop and maintain effective leadership and working relationships with all site personnel in accordance withpolicies and procedures. Responsible for guiding site with effective leadership skills, professional demeanor and positive approach. SUPERVISIONOversee several Clinical Research Coordinators and other staff, delegating tasks as appropriate to their training and capabilities.ESSENTIAL JOB FUNCTIONSAssist in defining and developing clinical research strategy and study protocols.Lead and execute clinical research studies and programs for the company.Distill research protocols into research plans with time lines and delegation of duties to appropriate research staff.Facilitate with the submission of Feasibility Questionnaires by providing prompt responses for necessary information regarding patient database and other study-related questions.Continually seek to improve site operations to enhance efficiencies to improve the overall profitability of the site.Select, coach, counsel and develop all site staff to ensure they possess the necessary knowledge and skills to achieve quality and revenue objectives.Conduct weekly site meetings to communicate information, provide continuing education, training and enhance teamwork.Perform quality reviews to ensure the adequate execution of protocols and ensure adequate site staff training as needed. Ensure that training of investigators and staff are current for all research studies on an ongoing basis.Assist with the development and implementation of corrective and preventive actions to maintain a high quality site.Provide leadership and manage the study recruitment to ensure enrollment goals are met or exceeded.Generate reports for supervisor on patient enrollment and tracking.Tabulate enrollment statistics and implement immediate actions to correct any inadequacies in reaching site's enrollment goals.Maintain meticulous oversight of how the research plan is executed and the performance of each member of the team.Monitor and ensure site compliance with company policies and procedures, quality assurance guidelines and all federal, state and local laws.Adhere to GCP, ICH, NIH, HIPAA, FDA Regulations and SOPs and provides guidance to site staff on adequate compliance.Practical knowledge of document processes and reporting of SAEs, 1572s, CRFs, ICFs, and other study related documentation to provide guidance to site staff as well as reviewing to ensure compliance.Manage and establish external CRO and clinical study site relationships. Establish rapport and maintain contact and interact with monitors and sponsors to ensure customer satisfaction.Manage and establish rapport with various persons involved in the study, including but not limited to the patients, relatives/friends of the patients, doctors, pharmaceutical sponsors and all levels of the company.Act as Liaison between site and other departments within company (budgets/contracts, finance, regulatory).Serve as main daily contact to Principal Investigator(s) and Sub-Investigator(s).Maintain source documents and subject files in accordance with policies and procedures.Ensure accurate, confidential and complete compilation of data.Assist in the maintaining of ongoing regulatory documents.Audit operations to ensure compliance with protocol and applicable regulations.Coordinate all aspects of the preparation for regulatory agency site visits, including paperwork required.Data analysis and reporting.Oversee the development, implementation of Standard Operating Procedures (SOPs), and updating ofSOPs to ensure consistent, safe, and efficient management of clinical trials and continuous improvementsin the fiscal integrity of clinical research activities.Lead the troubleshooting process to reach resolutions for any issues that arise during the course of a study.Supervise the securing and shipping of clinical specimens as required by the protocol.Maintain responsibility for the cost effective requisition of needed equipment, supplies, and outsourced services with acceptable suppliers.Ensure site is maintained in an attractive, safe and efficient manner.Perform other duties not specifically listed in this job description as assigned by their immediate supervisor.

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