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School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
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.
1. Serves as an expert resource to multiple study teams about regulatory and institutional policies and processes.
2. Screen's participants for all studies, including those that are complex in nature (e.g., procedural, and interventional studies).
3. Provides oversight and training for screening activities to multiple study teams.
4. Serves as an expert resource for multiple study teams for participant retention and liaises with other resources at Duke to optimize retention rates.
5. For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals; provides training.
6. Develops, oversees adherence, and trains multiple study teams in the use and development of standard operating procedures (SOPs).
7. Maintains study level documentation for all studies, including those that are complex in nature.
8. Provides oversight, training, and expertise to multiple study team s regarding study level and participant level documentation for all studies including those that are complex in nature and/or require Duke University Heath System (DUHS) billing.
9. Serves as an expert resource and trainer to multiple study teams for preparing and conducting complex study visits, developing tools, and implementing operational plans.
10. Provides direction to prepare for study monitoring and audit visits.
11. Creates, optimizes, and oversees the systems used by multiple teams to manage research specimens. Serves as expert resource and trainer to multiple study teams in specimen collection, processing, preparation, shipping, and maintenance.
12. For complex scenarios, recognizes when agreements are necessary within the research program. Facilitates the process by coordinating with study teams and appropriate Duke offices.
13. Leads team meetings and facilitates healthy communication between staff. Ensures good communication across multiple study teams, and mentors' staff to improve communication strategies.
Safety and Ethics
1. Ensures that multiple study teams/research program team members are appropriately identifying and documenting adverse event information.
2. 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. Pro vides 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.
3. Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review.
4. 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.
1. 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.
2. 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 correction, queries, and quality assurance resource, including liaising with and being knowledgeable about other related resources at Duke.
3. 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. 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 or multiple research teams/research program, as relevant.
1. Assists with or contributes to the development of funding proposals.
2. Independently reviews articles, synthesizes the literature, and uses to assist in the development of manuscripts or grant proposals.
3. Independently develops protocols for complex investigator-initiated studies, across multiple PIs or study teams.
4. Uses expertise in research design to provide significant contribution to protocols or research proposals.
5. Provides significant contribution or leadership on accepted, peer-reviewed publication or conference presentation.
6. Mentor's others in this area.
Study and Site Management
1. Mentors, trains, and oversees activities related to how teams communicate with sponsors and /or CROs. Oversees activities related to site visits.
2. Oversees use of systems and systems reports to manage research participants' activities and tracking/marking financial milestones. Oversees use of systems and systems reports to manage research protocol activities and maintaining current protocol information.
3. Makes feasibility recommendations for multiple study teams/research program. Develops and oversees processes to determine participation in trials.
4. Oversees management of resources (staff, supplies, equipment) for multiple study teams /research program. May manage the budget for research studies.
5. For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies.
6. Oversees implementation of operational plans across research program, including at multiple sites.
7. Works with the CRU or departmental leadership to ensure that studies are closed according to best practices and guidelines.
1. 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.).
2. Play's 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.
3. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams.
4. Train's others to communicate effectively within teams.
5. Facilitates resolution of issues associated with teams or communication.
6. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
Work requires an Associate's degree
Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years required experience.
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
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