CLINICAL RESEARCH COORDINATOR
Duke University
- Durham, NC
- Permanent
- Full-time
This NIH grant-funded position will support research focused on improving the experience of critical illness for patients, their families and loved ones, and clinicians. The work spans disciplines and addresses topics such as psychological distress, clinical communication, medical decision-making, health equity, and mobile health (e.g., app-enabled health interventions).Special skills:
Excellent communication skills are critical since this position will interact with people who may be in stressful life situations as well as with multidisciplinary collaborations. Candidates with high 'emotional intelligence' are desirable. Experience with EPIC, OnCore, REDCap, and qualitative data analysis tools (e.g., NVivo); interest in utilization of apps for intervention and data collection, are preferred.Operations:
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. 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. Screens participants for complex studies (e.g., procedural and interventional studies). 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 lead multidisciplinary meetings with various stakeholders.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:
Under direct supervision from Biostatistician and PI may perform basic analyses on structured 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. Assists with quality control and data cleaning as directed. Independently responds to queries created by a CRO or the data manager. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review data lifecycle and management plans for multiple study protocols. Identifies when various data standards should be used in creating eCRFs and EDCs and integrates as according to best practices. 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.). Assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants. Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators.Science:
Assists with or contributes to the development of funding proposals. Independently conducts literature searches and reviews. Independently, using scientific proposals from the PI, develops elements of research 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. 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. 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.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. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. 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.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.Job Code: 00001201 CLINICAL RESEARCH COORDINATOR
Job Level: 52Duke 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 jobsat 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.