REGULATORY COORD

Job description

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.

Occ Summary

Perform study specific regulatory and safety reporting processes across multiple studies in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes under the direction of the supervisor. May oversee the work of junior staff and train or mentor others in institutional and regulatory compliance.


Work Performed

Research 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. Develops or helps develop SOPs. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Prepares for and provides support for study monitoring and audit visits, including support for thereviewer. Addresses and corrects findings. May maintain study level documentation for international studies and develop resources and tools for management of international studies, and/or coordinate with other entities or offices. 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/or potential hold issues in collaboration with the Principal Investigator (PI). Leads meetings that are multidisciplinary, including those with complex objectives. Safety and Ethics. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handle issues appropriately. Develops consent plans and documents for participants for all types of studies, including those that are complex in nature. Identifies all adverse events (AEs), and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. Prepares and submits AE documents needed for regulatory and safety reporting to sponsors and other agencies. Recognize and employ the professional guidelines andcode of ethics related to the conduct of clinical research. Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. Data. Enters, 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. 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 research data security plans (RDSPs) 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.). Independently use and implement technology to enhance productivity or process. Scientific Concepts. Using scientific proposals from the PI, develops research protocols. Demonstrates a basic understanding of the elements of research study designs. Site and Study Management. Collects appropriate information to determine whether the study teams participation in a specific trial is feasible. May make feasibility recommendations. Ensures that studies are conducted in compliance with institutional requirements and other policies. Follows, and may develop or implement, protocol specific systems and documents including process flows. Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or contract research organizations (CROs). 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. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. May serve on committees and workgroups internal to Duke or externally in therapeutic area of research. Demonstrates resilience and is adaptive to change. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.


Knowledge, Skills and Abilities

Can easily use computing software and web based applications (e.g., Microsoft Office products and the electronic medical record).


Minimum Qualifications


Education

Completion of an Associate's degree


Experience

Work requires a minimum of two years of research and/or regulatory experience. experience. A Bachelor's degree may substitute for 2 years of required

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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Job No:
Posted: 4/7/2021
Application Due: 7/6/2021
Work Type: Full Time
Salary: