Duke University Job Description: SAFETY SURVEILLANCE ASSOC I (1096)

Occupational Summary

Assist in the design, training, implementation, and coordination of trial-specific safety reporting and data reconciliation processes and procedures under direction of Safety Surveillance Management. Participate in daily processing of safety data across multiple trials; and create, update, and maintain documentation for review by sponsors and trial management. Participate in the development and implementation of Safety Surveillance processes and standards.

Work Performed

Participate in discussions and assist in the design and implementation of trial specific safety reporting processes under direction of the Medical Monitor, Safety Surveillance Manager, or Safety Surveillance Associate III. Define reporting criteria and associated processes.

Draft and maintain trial-specific reporting plans, processes, and associated forms.

Create trial-specific safety reporting educational materials.

Train trial personnel and relevant Safety Surveillance personnel on plan/processes.

Participate in the design, testing and implementation of safety reporting databases and/or tracking systems and changes needed thereof.

Build and maintain effective relationships with key trial personnel.

Train trial personnel on trial-specific trial processes under direction of Safety Surveillance Associate III or Manager.

Perform trial-specific safety reporting processes across multiple trials in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and trial-specific protocols/plans and processes under the direction of Manager.

Assure compliance of general and trial-specific clinical research safety related processes with SOPs, FDA, NIH, and global regulations for the reporting of adverse events to regulatory agencies.

Perform clinical review of serious adverse event forms and associated documentation.

Communicate effectively with sites and trial personnel to obtain high quality safety data in a timely fashion.

Create draft clinical narrative for Medical Monitor review.

Enter safety data into appropriate database in accordance to trial specific working instructions.

Review data entry by Clinical Trials Assistants or Clinical Trials Specialists.

Work closely with sponsor and trial personnel on relevant safety data issues. Obtain Medical Monitor review of trial-specific safety data.

Create trial-specific data listings and reports for review by Safety Surveillance Associate III and/or Management.

Provide trial-specific reports to trial personnel per trial-specific processes.

Assist in the development of appropriate regulatory reports and associated documentation in accordance with SOPs and trial-specific processes under the direction of Safety Surveillance Associate III or Manager.

Assist in the development and implementation of trial-specific safety data reconciliation processes.

Provide routine updates and reporting to Safety Surveillance personnel and management to ensure timely communication regarding status of safety data and important safety related issues.

Assist in the development routine evaluation and modification of Safety Surveillance general safety reporting processes and forms under direction of Management.

Assist with other regulatory related duties.

Participate in training Safety Surveillance personnel and other clinical research personnel on safety reporting regulations, processes, and procedures.

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.

Required Qualifications at this Level

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.

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.