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REGULATORY COORD, SR

Job Title: REGULATORY COORD, SR
Job Code: 1220
FLSA: E
Job Level: 53
Revised Date: 05/01/2019
Job Family: JF 05

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Occupational Summary

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 regulatory issues of moderate to complex scope.

Work Performed

Research Operations.

Serves as an expert resource to multiple study teams about regulatory and institutional policies and processes.

For complex scenarios, recognizes when all types of agreements are necessary.

Directs teams to appropriate Duke offices for execution. Develops, oversees adherence, and trains multiple study teams in the use and development of standard operating procedures (SOPs).

Maintains study level documentation for all studies, including those that are complex in nature.

Provides oversight, training, and expertise to multiple study teams regarding participant and study level documentation for all studies including those that are complex in nature and/or require Duke University Heath System (DUHS) billing.

Provides direction to prepare for study monitoring and audit visits.

Serves as an investigational new drug (IND) submissions expert resource and assists junior staff to address FDA review or issues.

Provides oversight and guidance to those preparing documents, annual reports, and amendments required by the Federal Drug Administration (FDA).

Leads team meetings and facilitates healthy communication between staff. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.

May independently navigate conversations with foreign agencies and study teams to develop or obtain the required documentation for compliance with international regulations.

May assist others with ensuring regulatory compliance with international studies.

Safety and Ethics.

Provides oversight and training to multiple study teams who develop and submit documentation and information for Institutional Review Board (IRB) review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.

Ensures that multiple study teams are appropriately documenting adverse event information.

Provides oversight and training to multiple study teams who develop consent documents for participants in in all types of studies, including those that are complex in nature.

May serve as an expert resource with regard to developing consent forms; this includes liaising with and being knowledgeable about other resources at Duke.

Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.

May be responsible for summarizing and clarifying for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.

Data.

For multiple study teams, selects data capture methods and discusses advantages and disadvantages of each.

Implements data capture methods at the unit, division, or departmental level.

Independently designs electronic case report forms (ECRFs) and electronic data capture (EDC) to collect data according to protocol.

Oversees the process of quality assurance (QA), data corrections, and queries used by multiple study teams, including creating and using QA protocols, queries, summaries, and reports.

Recognizes trends, and recommends strategies to improve processes or retrain study teams.

Serves as a data corrections, queries, and quality assurance expert resource within clinical research unit (CRU), department, or division; including liaising with and being knowledgeable about other related resources at Duke.

Assists multiple study teams in developing protocols that include strategies and processes to ensure data security and provenance.

Recommends and leads implementation of improved processes, policies, and systems to ensure data security and provenance.

Serves as an expert resource to multiple study teams with regard to mapping data flow.

Predicts areas of vulnerability in the data flow plan.

Determines areas where data provenance may be compromised, and helps study teams work through solutions.

Ensures that study teams are familiar with data flow resources at Duke.

Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams, as relevant.

Scientific Concepts.

Independently develops 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.

Site and Study Management.

Makes feasibility recommendations for multiple study teams.

Develops and oversee processes to determine participation in trials.

For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies.

Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or contract research organizations (CROs). Develops and implements closeout procedures for multiple studies across multiple teams.

Leadership and Professionalism.

Encourages staff to take part in professional development opportunities and provides opportunities for staff to attend key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.).

Plays a key role on committees and workgroups.

Recognizes and escalates organizational issues that could be optimized to improve research process.

Actively facilitates and leads multiple study teams adoption of change in their working environment.

Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams.

Trains other to communicate effectively within teams and facilitates resolution of issues associated with teams or communication.

Required Qualifications at this Level

Education/Training

Completion of an Associate's degree

Experience

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

Skills

Can easily use computing software and web based applications (e.g., Microsoft Office products and the electronic medical record). Ability to utilize interpersonal and communication skills to get work done effectively.


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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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.