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SAFETY SURVEILLANCE ASSOC II
Job Title: SAFETY SURVEILLANCE ASSOC II
Job Code: 1097
FLSA: E
Job Level: 80
Revised Date: 08/15/2005
Job Family: JF 05
Occupational Summary
This position will design, train, implement, and coordinate trial specific safety reporting and data reconciliation processes and procedures with moderate to minimal direction of Safety Surveillance Management. Participate in daily processing of safety data across multiple trials and lead the team in the prioritization of tasks of routine or moderate scope. This includes the creation and maintenance of documentation for review by sponsors and trial management and regulatory agencies. Participate in the development and implementation of standard Safety Surveillance processes; as well as precept new Safety Surveillance employees and participate in general safety reporting training programs.
Work Performed
Design and implement trial specific safety reporting processes under direction of the Medical Monitor, or Safety Surveillance Management. Define reporting criteria and associated processes.
Independently 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.
Coordinate and perform trial-specific safety reporting processes across multiple trials of different therapeutic areas and phases, in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and trial specific protocols/plans and processes.
Assure compliance with SOPs, FDA, NIH, and global regulations for the reporting of adverse events to regulatory agencies.
Perform high quality 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 clinical narrative for Medical Monitor review.
Enter safety data and/or oversee data entry of safety data into appropriate database in accordance to trial specific working instructions.
Perform audit of safety database to monitor for quality data.
Work closely with sponsor and trial personnel on relevant safety data issues.
Obtain Medical Monitor review of trial specific safety data.
Review trial specific data listings and reports for quality and accuracy.
Provide trial specific reports to trial personnel per trial specific processes.
Develop appropriate regulatory reports and associated documentation in accordance with SOPs and trial specific processes under the direction of Medical Monitor and Management.
Coordinate the development and implementation of trial specific safety data reconciliation processes of moderate to complex nature.
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.
Coordinate the development of routine evaluation and modification of Safety Surveillance general safety reporting processes and forms under direction of Safety Surveillance Management.
Perform other regulatory related duties. Precept, mentor, and train new 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.
Required Qualifications at this Level
Education/Training
Four year degree in clinical research, life sciences, or healthcare related field.
(Examples of health related field professionals include but are not limited to: Registered Nurse, Physician's Assistant, Pharmacist, and Nurse Practitioners.)
Experience
Minimum of three years of clinical research experience is required.
Preferred experience is a minimum of three years of clinical research experience with at least one year of direct clinical safety research experience plus a minimum of one year of experience in a healthcare setting.
OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE.
Skills
Ability to Analyze Trends, identify issues, and problem solve complex issues and trends Ability to write and speak clearly and concisely in a variety of communication settings.
Good presentation skills Strong technical writing, editing, and proof reading skills. Proficient in computer skills, including MS Word and MS Excel Ability to perform multiple activities simultaneously.
Good communication and interpersonal relationship skills needed to work with internal and external clients General knowledge of clinical research processes.
General knowledge of Good Clinical Practices and 21 CRF 312 and 314 Good working knowledge of 21 CRF 312.32 and 21 CRF 314.80 and ICH.
Good Clinical Practices related to safety data processing.
Strong knowledge of key medical terminology Good attention to detail Valid U.S drivers license required.
Professional NC Medial License, when appropriate ACRP, CCRC, CCRP, or SoCRA, is a plus.
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 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, (including pregnancy and pregnancy related conditions), sexual orientation, or military 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.
