CLINICAL RESEARCH COORDINATOR, SR

Occupational Summary

Leads day to day operations of multiple study teams conducting clinical research at Duke Health; performs a variety of complex duties involved in the collection, compilation, documentation, and analysis of clinical research data; leads others in navigating the clinical research environment. Leads or participates in a variety of unit, department, or division level initiatives. Oversees the work of Clinical Research Coordinators and other research staff.

Operations:
For complex scenarios, recognizes when all types of agreements are necessary. Directs teams to appropriate Duke offices for execution. Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. Independently navigates conversations with foreign agencies and study teams to develop or obtain the required documentation for compliance with international regulations. May assist others with ensuring regulatory compliance with international studies. Oversees the management and documentation of investigational products (IP) for multiple study teams/research program. Serves as an IP expert resource for study teams. Designs, implements, and optimizes methods for handling IP. Provides direction to multiple study teams/research program to prepare for study monitoring and audit visits. Provides oversight, training, and expertise to multiple study teams/research program regarding participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require DUHS billing. Serves as an expert resource for multiple study teams/research program for participant retention. Liaises with other resources at Duke to optimize retention rates. For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals. Provides training. Screens participants for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training in screening activities to multiple study teams. Develops, oversees adherence, and trains in the use and development of SOPs across research portfolio. May provide input for institutional SOPs. Creates, optimizes, and oversees the systems for managing specimens for multiple study teams/research program.  Serves as an expert resource and trainer in specimen collection, processing, preparation, shipping and maintenance. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training and lends expertise to multiple study teams. Serves as an expert resource and trainer to multiple study teams/research program for preparing and conducting complex study visits, developing tools, and implementing operational plans. Leads effective facilitation of team meetings in order to achieve objectives. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.

Ethics:
Ensures that multiple study teams/research program team members are appropriately identifying and documenting adverse event information. Provides oversight and training to multiple study teams/research program team members who conduct and document consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May serve as an expert resource with regard to conducting and documenting consent including liaising with and being knowledgeable about other resources at Duke. Provides oversight and training to multiple study teams/research program team members who develop the consent plan and document. Serves as an expert resource with regard to developing consent plans and documents for participants in a variety of studies. Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review. Provides oversight and training to multiple study teams/research program team members who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.

Data:
For multiple study teams, selects data capture methods and discusses advantages and disadvantages of each. Implements data capture methods at the unit, division, or departmental level. Independently designs ECRFs and EDCs to collect data according to protocol. Maintains study-level documentation for all studies, including those that are complex in nature (e.g., involving datasets from multiple sources, big data, or non-standardized data). Provides oversight and training and lends expertise to multiple study teams. Oversees the process of QA, data corrections, and queries used within multiple study teams/the research program, including creating and using QA protocols, queries, summaries, and reports.  Recognizes trends, and recommends strategies to improve processes or retrain staff. Serves as an expert data corrections, queries, and quality assurance resource, including liaising with and being knowledgeable about other related resources at Duke. Assists multiple study teams in developing protocols that include strategies and processes to ensure data security and provenance.  Recommends and leads implementation of improved processes, policies, and systems to ensure data security and data provenance. Works with the CRU or departmental leadership to ensure that data is shared according to best practices and guidelines. Identifies when various data standards should be used in creating eCRFs and EDCs and integrates as according to best practices. Serves as an expert resource to multiple study teams/research program with regard to mapping data flow. Predicts areas of vulnerability in the data flow plan.  Determines areas where data provenance may be compromised, and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant. Develops, oversees adherence, and trains to multiple study teams on the results reporting for patients and providers. Provides guidance based on CRU and institutional best practices. Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators. Under supervision, executes testing process after the completion of a build, or following any project changes or system upgrades and may conduct some testing and documentation for Part 11 projects.

Science:
Independently develops substantial portions of funding proposals and grants. Assesses and determines solutions for operational shortcomings of proposals. Independently conducts literature searches and reviews. Independently, using scientific proposals from the PI, develops elements of research protocols for complex investigator-initiated studies, across multiple PIs or study teams. Uses expertise in research design to provide significant contribution to protocols or research proposals. Provides some contribution to scientific publications or presentations (no authorship).

Study and Site Management:
Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs. Oversees activities related to site visits. Oversees use of systems and system reports to manage research participants' activities and tracking/marking financial milestones. Oversees use of systems and system reports to manage research protocol activities and maintaining current protocol information. Makes feasibility recommendations for multiple study teams/research program.  Develops and oversees processes to determine participation in trials. 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. For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies. Oversees implementation of operational plans across research program, including at multiple sites. Develops and implements closeout procedures for multiple studies across multiple teams.

Leadership:
Encourages staff to take part in professional development opportunities. Keeps current with advances in the scientific area and considers the impact on the research program.  Keeps self and team current with research updates by attending external offerings; applies learned material on the job.  Plays key/leadership role on committees and workgroups. 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 actively facilitates the research program through change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation within the research program. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Establishes and assigns the activities of the research program team members to accomplish the study goals.

Special skills:
They need strong administrative, communicative and organizational skills.

Required Qualifications at this Level

Education/Training

Work requires an Associate's degree

Experience

Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years required experience.