REGULATORY COORDINATOR SENIOR
REGULATORY COORDINATOR SENIOR
Duke Office of Clinical Research
The research position for which you are applying is not specific to a clinical research area. Instead, your resume may be shared across the Duke School of Medicine in order to increase the visibility and likelihood of matching eligible candidates with open positions specific to the job title for which you have applied.
Lead, coordinate, and perform study-specific regulatory and safety reporting processes for a group of investigators, or an entire unit, department or division, in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), and study- specific protocols/plans and processes independently. Lead team in problem solving issues of moderate to complex scope.
1.Clinical research study operations. Coordinate regulatory activities for an assigned group of investigators, or an entire unit, department or division.
Develop and submit DUHS Institutional Review Board documents such as consent forms, protocols, and continuing reviews. Serve as a unit resource for development of IRB documents and for guidance on IRB communications. Maintain or collaborate to maintain appropriate study- level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Provide training in these areas.
Lead the development of and provide the appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes independently. Provide routine updates and reports to ensure timely communication regarding status of regulatory and/or important safety related issues.
Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings.
Complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently. Direct study team's compliance with submission and completion of AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently.
Conduct internal quality assurance audits of regulatory files. Lead the implementation of study specific regulatory processes of a moderate to complex nature. Develop and oversee the implementation of Standard Operating Procedures. Evaluate team's suggestions to improve processes and SOPs.
2.Data management and informatics. Enter and/or oversee protocol specific data into required institutional or protocol-specific systems. Review study specific data listings and reports for quality and accuracy. Provide study specific reports to appropriate personnel per processes. Provide solutions to make entry processes more accurate or efficient.
3.Leadership and professionalism. Encourage and support colleagues to complete project work. Assist research colleagues in identifying efficiencies and improving process.
Serve as expert mentor to junior regulatory staff. May assign, review, and train others in various work responsibilities and provide constructive feedback to other team members. Employ escalation and performance plans as needed. Establish and assign the activities of multiple teams to accomplish study goals.
Recognize and employ the professional guidelines and code 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.
Maintain Duke- and project- specific training requirements. May develop solutions to proactively ensure study team's compliance with training requirements.
Provide significant contribution and influence upon research work, activities, or productivity of project teams or across multiple groups. Successfully lead a committee, task force, or ad hoc group at the division, unit, department or institution level.
4.Study and site management. Use system reports to ensure unit, division, or department compliance with institutional requirement/policies, including those that are international; assist team members with understanding these requirements and policies. Oversee study teams' maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
5.Communication and team science. Communicate concerns clearly and in a professional manner. Recognize when others need to be brought into the conversation and escalate appropriately. Work closely with sponsor and study personnel on relevant regulatory and/or safety issues. Take action when communication has stalled with sites, CROs, sponsors, or team members. Act as an expert regulatory resource to junior staff liaising with sponsors, subcontractors, or vendors.
Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
2598 REGULATORY COORDINATOR III
Job Family Level
Full Time / Part Time
Regular / Temporary
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.
1.Completion of a bachelor's degree plus a minimum of four years of research and/or regulatory experience.
2.Completion of an Associates degree plus a minimum of six years research and/or regulatory experience.
Can easily use computing software and web-based applications (e.g., Microsoft Office products and the electronic medical record).
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
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.