CLINICAL RESEARCH COORDINATOR, SR - Center for the Study of Aging

Type of Research:

The Clinical Research Coordinator Sr. (CRC Sr.) will develop, coordinate and manage clinical research studies conducted by principal investigators affiliated with the Duke Center for Aging and Department of Neurology. The CRC Sr. will join a research team that is conducting a variety of studies on Alzheimer's Disease and related neurocognitive disorders.  This position will involve working with collaborators at multiple sites and may require travel between clinics and offsite locations. The CRC Sr. will lead day to day operations of multiple study teams conducting clinical research and provide oversight of CRCs and other research staff as the research portfolio of the team expands.

Special skills:
Preferred Qualifications:  Excellent verbal and written communication skills. Experience in training and overseeing others in study processes. Ability to oversee multiple personnel and studies. Recruitment and retention expertise. Experience or willingness to learn the administration of neuropsychological test battery and questionnaires with older adults as part of an evaluation for cognition.

Operations:
For complex scenarios, recognizes when agreements are necessary within the research program. Facilitates the process by coordinating with study teams and appropriate Duke offices. Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. 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. Develops and implements protocols for research program that include strategies and processes to ensure data security and provenance.  Serves as an expert data provenance and security resource, including liaising with and being knowledgeable about other related resources at Duke. Predicts areas of vulnerability in data flow across the research portfolio. Serves as an expert resource across research portfolio with regard to data capture, storage, management, quality, and preparation for analysis. Oversees implementation of data flow plans across the research portfolio. Ensures that study teams are familiar with and using data flow plan 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:
Assists with or contributes to the development of funding proposals. Independently reviews articles, synthesizes the literature, and uses to assist in the development of manuscripts or grant proposals. 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 research program, including at multiple sites. Works with the CRU or departmental leadership to ensure that studies are closed according to best practices and guidelines.

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.

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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