Clinical Research Specialist At Arringdon Orthopaedic Surgery

CLINICAL RESEARCH SPECIALIST, SR. @ Arringdon Orthopaedic Surgery Location

• Operations: For complex scenarios, recognizes when all types of agreements are necessary. Directs teams to appropriate Duke offices for execution. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention. May train or oversee others. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee others. Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s). Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study level documentation. Prepares documents, equipment, supplies, etc. Assists with the conduct and documentation of non-complex visits and scripted testing or interviews. Prepares for and leads research program meetings. Ensures good communication within the research program, including mentoring staff to improve communication strategies. Ethics: Under supervision may collect information about AEs, identified in the protocol or investigator brochure. Assists with the development of consent plans and documents for participants. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others. Data: Enters and collects data. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review data lifecycle and management plans for multiple study protocols. Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). May train or oversee others. Innovatively uses technology to enhance a research process. May train others. Science: Assists with or contributes to the development of funding proposals. Assists with simple literature searches. Using scientific proposals from the PI, develops elements of research protocols. Demonstrates a basic understanding of the elements of research study designs. Contributes to the development of scientific publications or presentations. Serves as an author on poster presentations or publications. Study and Site Management: Records participant accrual information and consent documentation for non-complex studies in clinical research management system. Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information. May train others. For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs. May train or oversee others. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows). May train or oversee others. Prepares studies for closeout and document storage. May train or oversee others. Leadership: Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Develops and implements solutions that work within the existing leadership or organizational structure. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Description of Portfolio Responsibilities: (Effort 25%): Determines short- and long-term goals of the research program/shared resource in collaboration with investigator(s). Identifies research programs/shared resources gaps, constraints, needs, and milestones; helps develop operational sustainability plan and communicates with PI to plan necessary resourcing. Manages and documents all aspects of research project lifecycle including: initiation, planning, executing, monitoring, and closing. Directs project staff in the execution of project activities in accordance with project plan and timeline. Communicates project/program progress with all major stakeholders and adjust plans and timelines according to feedback. Manages the research program or shared resource operations. Monitors and adheres to the established budget, and assists with budget development. Ensures that institutional communications are shared with research program staff and faculty. Maintains communication within program and with other departments or offices to accomplish the program objectives. Manages, mentors, and/or trains staff. Maintains an awareness of regulations, policies, and resources relevant to research and therapeutic area and applies knowledge to the development and execution of operational plan. Ensures that all programs and projects are compliant with all relevant regulations and policies. Provides guidance to staff on best practices in research study or program conduct (e.g., recruitment, consenting, study documentation, program evaluation, data capture, etc.). Provides intellectual contribution to the research program or shared resource, including developing and editing research proposals and manuscripts. Represents research program or shared resource on behalf of the PI at internal and external meetings. Develop, coordinate and supervise research, technical, and administrative activities of the projects conducted by operation, large network or principal investigator(s) including review and supervise activities performed by subordinates in the collection, compilation, documentation and analysis of research data. Two multi-site NIH funded human subjects research studies within the Division of GI. This position will NOT do any direct research staff management. However, research staff involved in execution of these 2 studies will provide updates and reports to this position. along with the current Lead of the GI. Stive Study (funded): 2.5 million. Awarded through 2027. R01 Study (awaiting award): 1.8 million. 5-year study This personnel will:
• Supervise work of technical and professional support personnel involved in planning, implementation; ensure distribution of supplies and equipment for execution of research protocols.
• Coordinate and supervise the technical training of visiting scientists, students and new employees according to established procedures. Will represent research program or shared resources on behalf of the PI at internal and external meetings, multi-site study meetings, conferences. Description of Clinical Responsibilities: Clinical responsibilities:
• Type of Research: Develop, coordinate and supervise human subjects research involving non-intervention trials, technical, and administrative activities of the projects conducted by operation, large network or principal investigator(s) including review and supervise activities performed by subordinates in the collection, compilation, documentation and analysis of research data. Special skills: -Collaborate in developing, improving and conducting project evaluation activities -Develop and implement laboratory policies and procedures -Data collection, data analysis, and the execution of the evaluation to ensure compliance with protocol guidelines and adherence to requirements of the contract; identify problems and take appropriate action; review study files to ensure accuracy and completeness of data. -Analyze and interpret data in conjunction with principal investigator (s), statisticians and other members of the research team as appropriate; prepare presentations and written reports and analysis setting forth progress, trends and appropriate recommendations or conclusions -Ensure fiscal oversight of project through the development of detailed budgets and schedules

Minimum Qualifications

Education

Work requires an Associate's degree.

Experience

One year of relevant experience. A Bachelor's degree may substitute for required experience.

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