Research Coordinator III - Full Time

Job Summary:
The Clinical Research Coordinator III in the Erlanger Institute for Clinical Research is responsible for providing overall coordination of research project(s) as well as training and development of Research Coordinators I & II while under the direction of the Research Coordinator IV / Senior, the Principle Investigator(s) and Erlanger Institute for Clinical Research. Must be detail oriented, with ability to multi-task, working flexible hours to meet the needs of patients for enrollments on research studies. This position would be the front line for study enrollments as needed at night and on weekends and as such must be able to work flexible hours.

To 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 or new studies. 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.

Education:
Required:
Bachelor's Degree and/or 3 - 4 years of experience as a Research Coordinator in clinical research.

Preferred:
Graduate from an accredited School of Nursing.

Experience:
Required:
3 - 4 years' prior experience in a research medical office or academic hospital setting. 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 requiring special education. Must have extensive experience with clinical trials management from initial start-up through patient management to final steps of close out.

Preferred:
Phlebotomy training and/or experience. Medical terminology

Position Requirement(s): License/Certification/Registration
Required:
Clinical Research Certification (SoCRA, CCRP or ACRP) must be current at the time of hiring.

Certification in Institution Review Board required Course in The Protection of Human Research Subjects (CITI) course, Conflict of Interest and Good Clinical Practice; International Air Transportation Association (IATA) certification for shipping dangerous goods and biological substances. If certification is not current at hire date then these must be completed within the first 3 months of employment. Current Driver's License.

Preferred:
Any additional certifications as required per clinical area and or research project.
License to practice nursing in the State of Tennessee if applicable.

Department Position Summary:
Study Conduct / Clinical Research Practice
A Research Coordinator III in the Erlanger Institute for Clinical Research is responsible for coordination of research project(s) under the direction of the Principal Investigator and assist in the recruitment, training and supervision of research staff.

Performs a wide range of office functions including; computer data entry and word processing, filing and record keeping; maintains up-to-date records and documentation on research protocol patients. Provides coordination of patient care for research patients according to protocols and standards of care. Ability to work in a typical office setting and inpatient areas within the hospital with some stressful situations and personal flexibility. Assist in Institutional Review Board (IRB) requirements.

Work schedules are determined by protocol activity and may demand flexible work hours. Integrate information from multiple sources to ensure that research proposals meet the necessary requirements of funding agencies and Institutional Review Boards. Develop overall efficiency of research data collection methods and optimize strategies for data management. Design, create and revise research tools as necessary to ensure quality data that correlates with research objectives. Coordinates multiple data collection efforts for one or more research projects which may include other collaborating agencies or institutions.

Consult with co-investigators on appropriate management of participant problems and concerns. Develop and manage interim reports for principal investigators, industry sponsors and institutional review board to ensure that each project is moving toward timely completion. Liaison between the project team and funding agencies or significant parties. Ensure that projects are executed successfully and completed within time frames to meet research objectives. Excellent oral and written communications skills; ability to relate well to people of a broad socioeconomic mix, with sensitivity to the patients, family and friends.

May be required to perform or delegate all duties of Research 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.

Recruitment
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.

Communication
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, physician's 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.

Data Management
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.

Education
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.