Senior Research Coordinator

The Senior Research Coordinator’s purpose is to lead a team in the local or central coordination of one or more multicenter research studies. The Senior Research Coordinator is accountable to the Principal Investigator (PI) and reports to the PI and research manager.  He or she is responsible for the management of staff assigned to the study, as well as the primary point of contact for internal departments (e.g. stats, finance, ICT , pharmacy, Core lab, CRLB, diagnostic imaging, patient care areas, etc.  ) and external stakeholders (e.g. sponsor, CRO, vendors, grant/funding agency).  
Senior Research Coordinator is responsible for all aspects of research projects highlighted below.  

Local Coordination:
• Work with director in selecting, planning, implementing and tracking research projects
• Recruit, train, and manage/supervise the local research team including research assistants, coordinators, students, and nurses.
• Account management.  Developing and negotiating study budgets based on trial resource requirements, managing and ensuring studies are completed within budget
• Manage all aspects of the study related to patient management and study implementation, provide training to health professionals and act as a liaison between the investigator/research staff and hospital departments
• Patient recruitment and Follow-up.  Responsible for patient screening, randomization, study drug/device allocation and accountability, patient follow-up, REB submissions, adverse event reporting, as well as accurate case report form completion on all patients.
• Liaise with sponsor, arrange monitoring visits and monitor local study conduct
• Audit preparation
• Travel as required for investigator meetings and conferences
• Carry a pager for after hours and weekend call

Central Coordination:
• Review and provide input into research study protocols 
• Ensure relevant clinical and research methodology is applied throughout the conduct of the research study.
• Request and evaluate various external vendors and facilitate contracts and budget negotiations with chosen vendors 
• Liaise and coordinate with internal departments to ensure requirements and timelines are achieved as required
• Support the PI in the identification, development and organization of required study committees (e.g. Steering, Event Adjudication, DSMB).
• Design   study management plans as required for the conduct of the research study (e.g., data management plan, monitoring plan, adjudication plan, investigational product (IP) management plan, safety management plan, etc.)
• Monitor study management plans throughout project and revise as necessary
• Recruit, hire and train required staff members to implement the research study
• Develop and design materials to assist in conduct of study, including informed consent form templates, recruitment materials, manual of operations, training material, etc.
• Train investigator site study personnel on research project
• Support sponsor and/or study sites in the initial submission and ongoing compliance to regulatory authorities, as required.
• Assist investigators and local sites with initial, annual and final ethics committee submissions  
• Coordinate regular meetings with internal and external stakeholders
• Develop and conduct training for investigator site and other local study staff
• Forecast recruitment, country/site activation, quantity of IP required to be packaged and shipped to country depots and sites, and required timing
• Organize, facilitate, complete and/or assist in the conduct of internal and external audits and inspections (e.g., IP vendors, investigator sites, national leader offices etc.)
• Control for risk identification, risk mitigation and issue resolution for the research study
• Develop targets and timelines for deliverables, anticipates potential delays and proactively develop strategies to achieve a positive outcome
• Create reports to review and monitor key quality indicators, such as recruitment, drug adherence and safety
• Monitor and ensure ongoing study compliance with the protocol, standard operating procedures and applicable regulations
• Serve as an escalation point for project issues
• Engage in quality assurance activities to ensure project deliverables are met according to both HHSC-Research SOPs and project requirements
• Participation on internal working groups and policy and standard operating procedure development and review
• Present at external and/or internal meetings
• Create presentation/slide content and meeting material development
• Prepare and present reports, abstracts, posters and academic manuscripts
• Develop tables and charts for manuscripts and/or presentations
• Organize and facilitate data transfers with external stakeholders (both incoming and outgoing)
• Coordinate the design, development and implementation of study database, and other required study systems as required.  (i.e. Randomization, drug management, websites) 
• Manage and coordinate the collection, entry, verification, analysis and reporting of research study data and quality indicators 
• Design of the study database, case report forms and required edit checks, in accordance with protocol and study requirements
• Organize and monitor of regular data collection activities, including quality control reports, data entry and data review/validation using pre-existing or newly created reports
• Ongoing management of data collection and validation systems, processes and associated documentation
• Identify staffing requirements/work
• Lead in recruitment process and recommend final candidate 
• Provide leadership, coaching, training and mentorship to study team members, including the development of bi-annual performance reviews
• Distribute and prioritize task assignments on a regular basis (daily/weekly)
• Manage the performance and workload for study team members
• Conduct and complete biannual performance reviews for direct report 
• Identify knowledge gaps for study team members and create development plans
• Negotiate and resolve conflicts among study team members
• Development of research study budgets, in collaboration with Finance, PI and PM.
• Negotiate budgets with vendors, sites, national leaders, in collaboration with Finance, PI and PM 
• Ongoing review and approve study-related invoices, patient fee runs and other study related payments and expenses
• Confirm ongoing adherence to study budget
• Contribute to writing and assembly of grant applications to external funding agencies 

• Minimum 5 years previous experience in multi-centre research studies
• Experience with the management of large clinical research datasets 
• Excellent communication, problem solving skills and ability to work flexible hours
• Working knowledge of project management processes
• Working knowledge of ICH-GCP Guidelines and international research requirements
• Broad knowledge of research methodology, clinical trials and drug development processes
• Supervisory experience
• Preferred: Working knowledge of HHSC systems, processes, organizational structure and SOPs.