CLINICAL RESEARCH COORDINATOR, SR

Occupational Summary 

The Department of Pediatrics is looking to hire an experienced Clinical Research Coordinator, Sr. to our Pediatric Neurology research group. Prior experience working in Pediatric populations, and working in complex clinical trials is preferred, but not required. This position will be responsible for complex clinical trials that take place in the Pediatric population. 

Work Performed 

Operations: 

· For complex scenarios, recognizes when all types of agreements are necessary. 

· Directs teams to appropriate Duke offices for execution. 

· Serves as an IND submissions expert resource. 

· Assists junior staff to address FDA review or issues. 

· Provides oversight and guidance to those preparing documents, annual reports, and amendments required by the FDA. 

· 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 multiple study teams/research program(s). 

· 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 team meetings and facilitates healthy communication between staff. 

· 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. 

· 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. 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. 

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 develops 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 significant contribution or leadership on accepted, peer-reviewed publication or conference presentation. 

· Mentors others in this area. 

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. 

· Oversees management of resources (staff, supplies, equipment) for multiple study teams/research program. 

· May manage the budget for research studies. 

· For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies. Oversees implementation of operational plans across multiple study teams or sites. 

· Develops and implements closeout procedures for multiple studies across multiple teams. 

Leadership: 

· Encourages staff to take part in professional development opportunities. 

· Provides opportunities for staff to attend key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.). 

· Plays key role on committees and workgroups. 

· Demonstrates interpersonal skills to get work done efficiently. 

· Recognizes and escalates organizational issues that could be optimized to improve research process. 

· Actively facilitates and leads multiple study team's adoption of change in their working environment. 

· Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams. 

· Trains others to communicate effectively within teams. 

· Facilitates resolution of issues associated with teams or communication. 

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. 

Skills 

Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

Minimum Qualifications

Education

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.

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