Occupational SummaryThe Department of Pediatrics is looking to hire an experienced Clinical Research Coordinator to our Pediatric Cardiology 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. We have a variety of trials and funding sources in Pediatric Cardiology. The position will work with a team of research professionals to support all of our Pediatric Cardiology faculty.Work PerformedOperations:· Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.· Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation.· Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI).· Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. Maintains study level documentation for international studies.· Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants.· Serves as the primary liaison with sponsors, IDS, and other parties as necessary.· Follows protocol schema for randomization and blinding/unblinding.· Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings.· Maintains participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR.· Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention.· Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues.· 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 or helps develop SOPs.· Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures.· Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).· Conducts activities for study visits in compliance with the protocol.· Contributes to the effective facilitation of team meetings to achieve predetermined objectives.· May train or oversee others and lead multidisciplinary meetings with various stakeholders.· May develop resources and tools for management of international studies, and/or coordinate with other entities or offices.Ethics:· Identifies all AEs, and determines whether or not they are reportable.· Collaborates with the PI to determine AE attributes, including relatedness to study.· Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care.· Develops consent plans and documents for participants in a variety of studies.· Develops and submits documentation and information for IRB review.· Communicates with the IRB staff and reviewers and handles issues appropriately.· Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.Data:· Enters and collects data. Develops data entry or collection SOPs or tools.· May provide oversight or training to study team members collecting or entering data. Ensures accuracy and completeness of data for all studies, including those that are complex in nature.· Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures.· Recognizes and reports security of physical and electronic data vulnerabilities.· May develop or review data lifecycle and management plans for multiple study protocols.· Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.).· Innovatively uses technology to enhance a research process.· May train others.Science:· Assists with or contributes to the development of funding proposals. Assists with simple literature searches.· Using scientific proposals from the PI, develops elements of research protocols.· Demonstrates a basic understanding of the elements of research study designs.· Contributes to the development of scientific publications or presentations.· Serves as an author on poster presentations or publications.Study and Site Management:· Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs.· Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits.· Uses required EMR functionalities to manage participants and study visits.· Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information.· Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations.· For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.· Ensure that studies are conducted in compliance with institutional requirements and other· policies.· Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows).· Prepares studies for closeout and document storage.· May train or oversee others and forecast effort needs.Leadership:· Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others.· Serves on committees and workgroups internal to Duke or externally in therapeutic area of research.· 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 is adaptive to change.· Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems.· Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.Required Qualifications at this LevelEducation/TrainingCompletion of an Associate's degreeExperienceWork requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.SkillsCan easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).Preferred Experience/Skills:Prefer in interest in Cardiology or previous working experience with children and their families. Experience in clinical research working with pediatric patients is preferred, but not required.Minimum QualificationsEducationCompletion of an Associate's degreeExperienceWork requires a minimum of two years of relevant 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.
