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Duke University Job Description: |
Job Title: CLINICAL RESEARCH COORDINATOR |
Job Code: 1201 |
FLSA: E |
Job Level: 52 |
Revised Date: 01/08/2024 |
Job Family: JF 05 |
Participates in or lead day to day operations of clinical research studies conducted by principal investigator(s) at Duke Health; performs a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks.
Research Operations
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
May prepare Federal Drug Administration (FDA) regulatory submissions in collaboration with Office of Regulatory Affairs and Quality (ORAQ), including development, submission, and maintenance of relevant documentation. Addresses FDA review and 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 standard operating procedures (SOPs).
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, Investigational Drug Service (IDS), and other parties as necessary. Follows protocol schema for randomization and blinding and unbinding.
May maintain study level documentation for international studies and develop resources and tools for management of international studies, and coordinate with other entities or offices.
Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings.
Maintains participant level and study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and require access to the Duke electronic health record (EHR).
Employs and may develop strategies to maintain recruitment and retention rates and evaluate processes to identify problems. Escalates issues.
Screens participants for complex studies (e.g., procedural and interventional studies).
Develops or helps develop SOPs.
Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures.
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.
Safety and 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 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 Institutional Review Board (IRB) review. Communicates with the IRB staff and reviewers and handle issues appropriately.
Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
Responsible for adherence to clinical research policies to ensure ethical conduct and protect vulnerable populations.
Communicates the difference between clinical activities and research activities, and the risks and benefits of study participation to research participants.
Data
Enters and collects data, and 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 protocols 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.
Prepares tables, data visualizations, and lay summaries to communicate study results to participants.
Develops reports on study progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders.
Scientific Concepts
Assists with or contributes to the development of funding proposals.
Independently conducts literature searches and reviews.
Demonstrates and applies a basic understanding of open science practices and the FAIR data principals.
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 and serves as an author on poster presentations or publications.
Site and Study Management
Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and contract research organizations (CROs).
Uses clinical research management system and its reports to manage research participants activities, calendars, tracking and 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 teams participation in a specific trial is feasible. May make feasibility recommendations.
For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs.
Ensures that studies are conducted in compliance with institutional requirements and other policies.
Follows, 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 and professionalism
May train or oversee others in the above tasks. 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. May serve 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.
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.
| Education/Training: | Completion of an Associate's degree |
| Experience: | Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience. |
| Skills: | 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.
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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.