Responsible for the coordinating, implementing, tracking and evaluating NGHS research studies. This includes all phases of the research cycle:
Ensures compliance with IRB approved recruitment, screening and consenting procedures, identifies preliminary cohorts, recruits and screens potential study participants
Facilitates the development of study-related training for study stakeholders as required in protocol, and coordinates the deployment of the sessions, running these if needed.
Provider and staff research skills education: Develop engaging educational content to address specified outcomes for current stakeholders, and potential stakeholders at all levels of NGHS.
Works with relevant data developers, analysts, data scientists and statisticians to collect, organize and manage study relevant data in a structure that aligns with NGHS IT data collection standards. Secures data in compliance with institutional and local, state and Federal requirements as well as study sponsor requirements. Acts as super user and trainer of NGHS data collection and analysis assets.
Coordinates and collaborates in collection of departmental specified metrics in a timely and accurate manner, presenting these metrics in a digestible manner for each stakeholder group as set out in departmental standard work.
Follows program required standard work and research study processes.
Study Initiation (Study Assessment, Development, and Approval)
Helps to identify potential cohort numbers (sample frame) through patient cohort development, manages feasibility study, or pilot test as appropriate. Helps coordinate study start up activities. For each activity, the coordinator is responsible for project management of all aspects of the process in line with the approved protocol, including grant sponsored and clinical trial projects
Manage and communicate effectively with Research Leadership regarding proposed projects for feasibility, including analyzing scope of work, cost and responding to inquiries and/or complaints
Prior to implementation, carry out a needs and resources assessment on the protocol and meet with appropriate service groups/vendors to design and confirm a resource plan and timeline to maximize efficiency of NGHS/study resources in a strategic interdependent manner. Review protocol for potential operational issues, and make alternate recommendations, as needed.
Using knowledge of institutional, local, state and Federal research related informed consent requirements, ensure consent documentation and described processes are compliant according to appropriate guidelines.
Evaluate IRB requirements for each protocol for completeness, guiding appropriate completion by investigator and appropriately submit and track progress of protocols, informed consents and any necessary documents to Institutional Review Board (IRB) for study determination and/or approvals; communicate with IRB if applicable. Add IRB submission to NGHS IRB tracker and update with approvals. Securely store IRB communication, modifications, approvals etc. in program approved manner. Assist investigators in IRB protocol reviews as necessary.
Attend IRB meetings for protocol review, as needed
Confirm that all required and /or regulatory documents are submitted to sponsor / securely stored in a timely manner, e.g., 1572, Confidentiality Agreement, clinical trial agreements, IRB approval letter, Financial Disclosures, etc., as needed.
Maintain current study team member resumes, CITI certifications, study-specific training and licenses are current.
Communicate with Research Leadership regarding study initiation needs, updates central research tracker on a timely basis. Schedules and monitors approved implementation tasks and timeline.
Coordinator tracks and documents progress through each stage of the protocol, ensuring that the personnel identified and approved by the PI and listed in the protocol adhere to the protocol, reporting any variances, deviation, or barriers noted to the PI in a timely fashion.
Research documentation environment and hard research study assets: Ensure use of approved, secure, digital and building storage space for any study documentation, data storage, device, or product storage. Ensure appropriate maintenance is carried out on device and products used including cleaning and calibration by approved vendors.
Study Execution (data collection, analysis, dissemination and completion phases)
Ensure that the approved recruitment, screening and consent processes are adhered to for cohort defining and participant enrollment.
Securely retain study documentation and report any deviations from approved protocol to the study team and principal investigator. Report any variance following institutional standard policies.
Collaborate with approved stakeholders, and oversee specified data management process, providing progress reports to PI and co-investigators.
Ensure all phases of data management process are adhered to, and documented. Reporting variances or deviations to Department Director and PI.
Maintain strong working knowledge of Standard Operating Procedures (SOPs), FDA regulations and developing data management standards
Update central project tracker on a timely basis. Complete Case Report Forms (CRFs) and Study related documents, submit documents to sponsor and or IRB, if applicable. Including interim reports for awarded grant projects, financial summaries as required.
Ensure sponsor required documents are completed, e.g., screening logs, Adverse event (A/E) forms, memo to file, etc. Inform Program Director of variances or expected barriers.
Plan, organize, and participate in accreditation site visits, site initiation visits and continued monitoring visits.
Review research progress tracker and applicable monitoring reports with the Research Department Team, ensuring that the Program Director is aware of variances, barriers, and opportunities for innovation.
Ensure studies are completed on time and within budget by maintaining a detailed and up to date financial statement. Report any recommendations or expected, experienced variances to the program director in a timely fashion.
Communicate with outside vendors such as device vendors, grant awarding bodies, data mart developers, central laboratories, central IRBs, etc.
Provide guidance and troubleshoot issues, documenting these in the research management notes, communicating these to the program director. Proactively address study concerns and develop timely resolutions.
Present at internal and external events - academic presentations, professional research conferences and promotion events
Prepare interim report for PI, coordinate the documentation, reporting and analyses of safety issues, patients care issues, and study design and/or study conduct issues to the PI and on approval, appropriate IRB, sponsor and Program Director, as per department process.
Ensure that Adverse Events (AE) and Serious Adverse Events (SAE) procedures are followed accurately and within federal regulations and sponsor guidelines.
Prepare study reports as requested by PI, e.g., modification, amendments, funding requirements, resource needs assessment, Investigational New Drug (IND) reports, etc.
Perform required review of studies, completing yearly documents required by grant issuer, sponsor, IRB and FDA.
Provide guidance and editing services to non clinical trial investigator study manuscripts, ensuring ethical authorship and citation standards are adhered to.
Audit and maintain study and regulatory binders, grant documentation both hard and digital copies and report any gaps to the PI.
Ensure timely and accurate communication with the project stakeholders including sponsors, investigators, among research staff, and with the multiple functional areas with Institution, e.g., via regularly scheduled calls, team meetings, etc. Document these appropriately, including attendance.
Complete status reports and communicate with the sponsor, research staff, Research Manager and Investigator(s). Update central progress tracker.
Work with the key functional departments to coordinate the project-related activities to meet project goals and milestones, based on the study design.
work with investigators to ensure study data is submitted on-time to data management for analyses, and coordinate any data validation meetings with the data developer.
Ensure the statistical analysis plan is complete, if applicable.
Ensure information is available for final study report completion.
Performs related responsibilities as required
