To oversee & participate in the coordination, conduct and analysis of complex clinical research studies. To act as a leader within the department through improving clinical research practice and serving as a resource within the department, Erlanger and the community. To be accountable for high standards of clinical research practice and to assist in the development of accountability in others. The individual will assist Principal Investigator and Management with assessing feasibility. Organizes and participates in Study Initiation Visits (SIV) in collaboration with the Study Team. Attends site disease group tumor board meetings and site disease group collaborative meetings, as applicable. Works directly and communicates with EICR Leaders and/or Managers to meet EICR goals.
Bachelors or higher degree and/or 4 or more years of extensive, documented related on-the-job experience.
Baccalaureate or higher degree in related field.
Two or more years prior experience in a related medical field, knowledge of organizational functions, policies and regulations; knowledge of current trends and new developments; knowledge of principles and practices of clinical research applicable to those areas requireing special education. Position Requirement(s): License/Certification/RegistrationRequired:
Certification in Institution Review Board required Coruse in the Protection of Human Research Subjects (CITI) course within 1 month; International Air Transporation Assocation (IATA) certification for shipping dangerouse goods and biological substances within 6 months; Certified in Clinical Research within one year of hire;
BSN with active TN license
Clinical Research Certification
Department Position Summary:
Study Conduct/ Clinical Research Practice
May be required to perform all duties of Study Coordinators, Research Nurses, Research Assistants and support staff. Serve in leadership role and as a resource for others for all aspects of conducting clinical trials for complex and multi-center trials. Directly (or indirectly) supervise other Coordinators or support staff involved in clinical research work. Collaborate on multiple projects or studies of increased complexity. Serve as a resource for study team members and other departments/divisions that may be involved with specimen collection, processing, storage and tracking for clinical trials. Lead activities designed to improve organizational performance such as process improvement projects. Provide input to department/division discussions. Work independently and look for opportunities to grow clinical research projects within assigned division. Act as a role model with a significant expertise, knowledge and experience in coordination of clinical research. Be recognized as an expert, organization-wide resource, and contributor to professional knowledge for conducting complex trials.
Develop, implement and execute recruitment strategies to identify potential participants for large, complex projects. Engage study staff to assist in identifying and enrolling participants. Proactively identify and monitor barriers to recruitment and problem solve or innovate to overcome them. Determine best method/s to identify potential participants for research protocol (advertisements, chart reviews, monitoring of clinic schedule, etc.) and prepare accordingly. Create and maintain a detailed tracking system for participants considered for enrollment. Track progress at regular intervals and report out to PI, management, and required regulatory agencies.
Compose clear, precise and detailed correspondence. Document, organize and maintain all correspondence. Oversee and follow through on questions and issues that arise during study conduct. Serve as a liaison to internal departments, clinical teams, regulatory agencies, physicians offices, city clinics, government agencies, academic centers, and other organizations. Communicate study related issues to investigators, sponsors, coordinating centers, study coordinators, clinical team, managers and other institutions in a timely fashion. Develop a rapport with study participants.
Develop and maintain data management plan and SOPs for projects. Oversee data entry and validation to ensure accuracy, quality and compliance of data collection process. Create Source and CRFs in consultation with other team members using existing study data information to promote efficient data collection and data entry. Create Data Dictionary, per protocol and in conjunction with principal investigator and statistician. Oversee the design of auditable database, data collection forms, error checking methods, and related programs for collection, analysis, and reporting. Support the data-management process for clinical research projects, data query management from data managers, project statistician, and sponsors. Maintain and audit data, providing status and activity reports as required. Organize data to analyze, identify, and report trends. Review reports, tables, and listings. Maintain data storage for clinical research studies, and master database files for clinical research protocols. Prepare reports from validation studies of clinical research projects. Evaluate and resolve discrepancies within reports. Ensure quality of data submitted from study sites and assure timely submission of data. Oversee the processing of laboratory and other external data.
Train new staff in preparation and conduct of clinical trials. Assist in developing and delivering guidelines and educational materials for investigators, research support staff and the clinical team (as applicable). Complete required training. Serve as a resource to team members. Assist other members by educating, providing resources and consulting on difficult protocols or projects. Assist investigators in developing presentations, abstracts and manuscripts. Act as a mentor and contribute to the professional growth of others. Act as an expert, organization-wide resource and contributor to professional knowledge.
Regulatory Compliance and Documentation
Work with regulatory team to manage multiple complex regulatory projects. May lead regulatory staff. Organize and manage activities for the preparation, review, submission and maintenance of regulatory activities to collaborative parties. Provide oversight of periodic internal self-audit of records. May lead monitor visits, audits, and quality reviews (internal and external). Works with regulatory to manage the review, correspondence and approval of human research protocols with all regulatory authorities, including study closeout. Determine which research protocols or issues have additional requirements, i.e. review by additional Erlanger Divisions, regulatory agencies, consultants, and data safety monitoring boards, and coordinate the process to meet these requirements. Act as an expert resource for regulatory affairs. Mentor and lead others in applying federal regulations; state and local law; Erlanger and department/divisional policies and SOPs to promote ethical practices in research involving human participants and to ensure compliance to those regulations. Ensure the documentation of regulatory activities in appropriate systems. Manage the maintenance of up-to-date and accurate written and electronic records and files. Develop and maintain the regulatory binder with regulatory staff.