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CLINICAL RESEARCH COORDINATOR, SR
Job Title: CLINICAL RESEARCH COORDINATOR, SR
Job Code: 1202
Job Level: 53
Revised Date: 05/01/2019
Job Family: JF 05
Lead day to day operations of multiple study teams conducting clinical research at Duke Health; perform a variety of complex duties involved in the collection, compilation, documentation, and analysis of clinical research data; lead others in navigating the clinical research environment. Lead or participate in a variety of unit, department, or division-level initiatives. Oversee the work of Clinical Research Coordinators and other research staff.
Serves as an expert resource to multiple study teams about regulatory and institutional policies and processes.
Screens participants for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
Provides oversight and training for screening activities to multiple study teams.
Serves as an expert resource for multiple study teams for participant retention and 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.
Develops, oversees adherence, and trains multiple study teams in the use and development of standard operating procedures (SOPs).
Maintains study level documentation for all studies, including those that are complex in nature.
Provides oversight, training, and expertise to multiple study teams 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.
Serves as an expert resource and trainer to multiple study teams for preparing and conducting complex study visits, developing tools, and implementing operational plans.
Provides direction to prepare for study monitoring and audit visits.
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.
Serves as an investigational new drug (IND) submissions expert resource and assists junior staff to address Federal Drug Administration (FDA) review or issues.
Provides oversight and guidance to those preparing documents, annual reports, and amendments required by the FDA.
Serves as an investigational products (IP) expert resource for study teams.
Designs, implements, and optimizes methods for handling IP.
Oversees the management and documentation of IP for multiple study teams.
For complex scenarios, recognizes when all types of agreements are necessary.
Directs teams to appropriate Duke office for execution.
Leads team meetings and facilitates healthy communication between staff. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.
May independently navigate 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.
Safety and Ethics.
Provides oversight and training to multiple study teams who develop and submit documentation and information for Institutional Review Board (IRB) review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.
Ensures that multiple study teams are appropriately identifying and documenting adverse event information.
Provides oversight and training to multiple study teams who conduct, document, and develop consent plans for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care.
Serves as an expert resource with regard to conducting, documenting, and developing consent plans for participants in a variety of studies.
This includes liaising with and being knowledgeable about other resources at Duke.
Serve as a resource to help staff and patients recognize the difference between clinical care and clinical management of research participants.
Provide training in ethical conduct of research to multiple study teams.
Serve as expert resource to study teams, as they design studies, so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.
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 electronic case report forms (ECRFs) and electronic data capture (EDC) to collect data according to protocol.
Oversees the process of quality assurance (QA), data corrections, and queries used by multiple study teams, including creating and using QA protocols, queries, summaries, and reports.
Recognizes trends, and recommends strategies to improve processes or retrain study teams.
Serves as a data corrections, queries, and quality assurance expert resource within clinical research unit (CRU), department, or division; 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 provenance.
Serves as an expert resource to multiple study teams 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 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, as relevant.
Independently develops substantial portions of funding proposals and grants and provides to Principal Investigator (PI) for final approval.
Assesses and determines solutions for operational shortcomings of 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.
Independently conducts literature searches and reviews and provides significant contribution or leadership on accepted, peer reviewed publications or conference presentations.
Mentors others in this area.
Site and Study Management.
Makes feasibility recommendations for multiple study teams.
Develops and oversee processes to determine participation in trials.
For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies.
Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or contract research organizations (CROs). Oversees activities related to site visits, implementation of operational plans across multiple study teams or sites, and management of resources (staff, supplies, equipment) for multiple study teams. May manage the budget for research studies.
Oversees use of systems and system reports to manage research participants activities and charge routing.
Develops and implements closeout procedures for multiple studies across multiple teams.
Leadership and Professionalism.
Encourages staff to take part in professional development opportunities and provides opportunities for staff to attend key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.).
Plays a key role on committees and workgroups.
Recognizes and escalates organizational issues that could be optimized to improve research process. Actively facilitates and leads multiple study teams 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 other to communicate effectively within teams and facilitates resolution of issues associated with teams or communication.
Required Qualifications at this Level
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.
Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University 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 essential job 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.