Regulatory Research Coordinator II

Job Summary:
The Research Regulatory Coordinator II in the Erlanger Institute for Clinical Research is responsible for providing overall coordination of regulatory data submissions for new study activations as well as ongoing study submissions as appropriate for each open study. Responsible for training and development of Research Regulatory Coordinator I positions as well as continued oversight of day to day duties of these individual positions. Must be detail oriented, with ability to work independently and handle multiple projects simultaneously, working flexible hours to meet the needs of patients for enrollments on research studies. Participates in Study Initiation Visits (SIV) in collaboration with the Research Coordinators, Nursing Coordinators and Principle Investigators. Attends site disease group tumor board meetings and site disease group collaborative meetings, as applicable. This position will have ability to cross cover for the Research Coordinator Senior position and would be acting as the front line for study enrollments as needed at night and on weekends and as such must be able to work flexible hours. Works and communicates with EICR Leaders and/or Managers to meet EICR goals.

This position will 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 regulatory submissions related to clinical research and to assist in the development and accountability of others. The individual will assist Principle Investigator and Management with assessing feasibility of new studies.

Education:
Required:
Bachelor's Degree and/or 4 years of experience working in clinical research or other related field

Preferred:
Graduate from an accredited School of Nursing

Experience:
Required:
Four or more year's prior experience in a research medical office or academic hospital setting or other related field. Two years or more of research regulatory experience. Must have knowledge and ability to apply policies, regulations and principles of clinical research to all areas requiring special education.

Preferred:
Experience with research grants and in health care system

Position Requirement(s): License/Certification/Registration
Required:
Clinical Research Certification (SoCRA or ACRP). Regulatory Affairs Associates Certification (RAPS) or be able to obtain within 6 months from hire date. Certification in Institutional 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:
Clinincal Research experience
Experience in regulatory affairs in industry

Department Position Summary:
Works with senior coordinator to review and performs audits of case report forms, informed consents, and other study related material. Responsible for oversight of maintaining monthly billing for study visits and documents appropriate fees on research referral forms. Oversees the collection of data from patient charts, medical records, interviews, questionnaires and other sources. Organizes and facilitates meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate for research objectives. Submits all research related contracts and supporting documents to IRB Administrator to be entered into Contract Collaborator and keeps track of their progress as they move through the system, giving weekly updates to management acting as a secondary monitor in the process.

Develop and maintain up to date departmental policies and procedures as needed. Monitors departmental employee time in the Kronos system to ensure adequate office coverage. Responsible for the oversight of the maintenance of departmental information ensuring up-to-date faculty CVs, current licensures, lab certifications, lab normal and abnormal values, staff training certifications along with any additional protocol specific requirements. Works with Marketing and the research specialist to ensure currently enrolling studies are updated on EHS website. Performs special projects as assigned. Must be a professional, multi-skilled person dedicated to being a resource in all aspects of research practice.

Responsible for the organization, and preparation of all study start-up documents, billing and compliance worksheets, and regulatory document forms. Responsible for approval of all regulatory documentation to IRB, sponsors, CROs, etc. Prepares regulatory documentation for monitor visits; interacts with study monitor during visit to ensure that regulatory documents are accurate and complete. Communicates with Research team, clinicians, sponsors and ancillary departments regarding necessary documents, timelines and study related deadlines in order to maintain accurate documents including but not limited to medical licenses, CVs, IRB submissions, study closure reports and budget timelines. Responsible for preparation, submission of documents needed for IRB, sponsors, CRO and as needed for reviews and approvals.

Performs audits of case report forms, informed consents, and other study related material. Maintains monthly billing for study visits, documents appropriate research service fees on invoices according billing grids. Assists with prescreening patients, collection of data from patient charts, medical records, interviews, questionnaires and other sources to meet study deadlines. Organizes and facilitates meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate for research objectives.

Study Conduct/ Clinical Research Practice
May be required to perform all duties of Regulatory Coordinators, 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 significant expertise, knowledge and experience in coordination of clinical research and regulatory submissions/tacking. Be recognized as an expert, organization-wide resource, and contributor to professional knowledge for conducting complex trials.

Recruitment
Works with research coordinators to 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.

Work with research coordinators to 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
Work with research coordinators to 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 all required trainings as scheduled. Serve as a resource to team members. Assist other members by educating, providing resources and consulting on difficult protocols or projects. 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. 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). 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.