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SAFETY SURVEILLANCE ASSOC III
Job Title: SAFETY SURVEILLANCE ASSOC III
Job Code: 1098
FLSA: E
Job Level: 74
Revised Date: 08/15/2005
Job Family: JF 05
Occupational Summary
This position will lead the design, implementation, training, and coordination of moderate to complex trial specific safety reporting and data reconciliation processes and procedures with minimal direction of Safety Surveillance Management. Participate in daily processing of safety data across multiple trials and lead the team in the prioritization and problem solving of issues of moderate to complex scope. Participate in the development of Safety Surveillance budgets and proposals; and precept and mentor Safety Surveillance and other Duke employees. Acts as a liaison with internal and external clients to develop programs and processes that meets both the regulatory requirements and objectives of the trial or project. This position will share knowledge and represent Duke University and Duke Medicine through the participation in professional clinical research conferences and publications. Develop, implement and train internal and external clients regarding standard Safety Surveillance processes.
Work Performed
Lead in the design and implement trial specific safety reporting processes of moderate to complex nature under direction of the Medical Monitor ,or Safety Surveillance Manager.
Define reporting criteria and associated processes. Independently draft and maintain trial-specific reporting plans, processes, and associated forms for review by Safety Surveillance Management.
Create trial specific safety reporting educational materials.
Train trial personnel and relevant Safety Surveillance personnel on plan/processes.
Coordinate the design, testing and implementation of safety reporting databases and/or tracking systems and request changes as needed.
Build and maintain effective relationships with key trial personnel.
Independently train trial personnel on trial specific trial processes.
Lead, 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 (SOP???s), and trial-specific protocols/plans and processes.
Lead team in problem-solving issues of moderate to complex scope.
Assure compliance of general and trial specific clinical research safety related processes with SOP's, 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 using various methods and approaches.
Create clinical narrative for Medical Monitor review.
Perform 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 and approve trial specific data listings and reports for quality and accuracy.
Provide trial specific reports to trial personnel per trial specific processes.
Review and approve internal trial specific safety reporting processes and procedures for Safety Surveillance Associates at all levels.
Develop appropriate regulatory reports and associated documentation in accordance with SOP's 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.
Participate in the creation of trial specific safety reporting budget and proposals, out of scopes, and associated business activities under the direction of Management.
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.
Lead 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.
Participate in the performance evaluation process for Safety Surveillance employees.
Share knowledge of safety reporting regulations, processes, and related issues through participation in professional meetings and clinical research forums and/or through publication.
Leads the development and implementation of internal training program for safety reporting and related activities.
Performs special assignments as requested by Safety Surveillance Management.
Perform other related duties incidental to the work described herein.
Required Qualifications at this Level
Education/Training
Four year degree in life sciences, clinical research 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 five years of clinical research experience with a minimum of three years of direct clinical safety research experience is required.
Preferred experience is a minimum of five years of clinical research experience with at least three years of direct clinical safety research safety experience, plus a minimum of one year of experience in a healthcare setting.
Skills
Strong Problem Analysis and resolution skills regarding identifying, complex issues, and resolving complex issues.
Excellent ability to write and speak clearly and concisely in a variety of communication settings.
Excellent 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 Strong communication and interpersonal relationship skills needed to work with internal and external clients Strong team leading skills.
Excellent working knowledge of clinical research processes Strong knowledge of Good Clinical Practices and 21 CRF 312 and 314 Excellent 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.
Strong attention to detail.
Valid U.S driver's license required.
Professional NC Medial License, when appropriate ACRP, CCRC, CCRP, or SoCRA, is a plus. 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.
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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.