Assoc Safety Admin I

Summarized Purpose:
Provides contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries and physician assessment of
diagnostics.

In collaboration with Medical Project Coordinators and Medical Monitors, liaises and establishes effective relationships with functional team members to accurately manage all incoming safety/medical monitoring documentation.

Essential Functions and Other Job Information:

Essential Functions:

Coordinates the timely review of protocol inquiries, triage of abnormal lab alerts and diagnostics, tracking all necessary data and generating reports for the client, project team and/or external vendors.

Identifies and redacts subject identifiers per local requirements; retraining sites and escalates reoccurrences to PPD Data Privacy.

Manages project specific training in collaboration with the project lead/manager, PV Lead, and the Project specific training team, including the application of training within the learning management system.

Performs data entry into tracking systems and performs system reconciliations to identify issues which may negatively impact project timelines.

Coordinates and facilitates project and/or client meetings, drafts meeting minutes, posts to client portals and distributes to internal and external project teams.

Manages the set-up, maintenance and archival of program files within PPD's electronic filing system.
Liaises with various internal function groups to implement projects, ensuring contractual obligations are met and timelines are achieved.
Supports any specific activities performed by the local office, which cannot be performed from elsewhere.
Job Complexity - Works on assignments that are routine in nature, requiring limited judgment. Has little or no role in decision-making.
Job Knowledge - Acquires job skills and learns company policies and procedures to complete routine tasks.
Supervision Received - Normally receives detailed instructions on all work. Works under close supervision.
Business Relationships - Contacts are primarily within immediate work unit. Contacts involve obtaining or providing information requiring little explanation or interpretation.

Qualifications:

Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
Self-motivated, positive attitude with effective oral and written communication and interpersonal skills

Excellent computer skills to include:
MS Office (Word, Excel, PowerPoint, Access)
Ability to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlines
Strong attention to detail and accuracy with orientation toward careful and meticulous work
Ability to work in a team or independently, demonstrating initiative to complete assigned tasks with moderate supervision
Ability to maintain a positive and professional demeanor in challenging circumstances
Flexibility to reprioritize workload to meet changing project timelines
Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and the organization's/Client SOPs and WPDs for all nonclinical/clinical aspects of project implementation, execution and closeout

Management Role:
No management responsibility

Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment
Potential drives to site locations and/or travel required on rare occasion
Majority of work computer-based

Physical Requirements:
Frequently stationary for 4-6 hours per day
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
Occasional mobility required
Occasional crouching, stooping, bending and twisting of upper body and neck

Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

Ability to access and use a variety of computer software developed both in-house and off-the-shelf
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
Frequently interacts with others to obtain or relate information to diverse groups
Works independently with guidance or reliance on oral or written instructions and plans work schedules to meet goals
Requires multiple periods of intense concentration
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
Ability to perform under stress and multi-task
Regular and consistent attendance

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