About the role
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Provides administrative and technical support to the Project Team. Coordinates and facilitates project activities and may serve as a study lead acting as a cross-functional liason for the project team. Acts as a buddy during onboarding phase and provides training to new staff as needed. Supports departmental and cross-functional initiatives for process improvements/enhancements.
Day to day:
According to the specific role (Central or Local), coordinates, oversees and
completes functions on assigned trials activities detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as assigned
and documents findings in appropriate system.
Ensures allocated tasks are performed on time, within budget and to a high
quality standard. Proactively communicates any risks to project leads and line
manager as appropriate.
Supports the maintenance of study specific documentation and global support
with specific systems, tools and trackers including but not limited to: study team
lists, tracking of project specific training requirements, system access
management for organization/vendor/clienst, and tracking of project level
activity plans in appropriate system. Ensures (e)TMF is up to date by following
file review schedules and documents findings in appropriate system.
Provides system support (i.e. GoBalto & eTMF).
Supports RBM activities.
Performs administrative tasks on assigned trials including but not limited to:
timely processing of documentssent to Client (e)TMF as assigned, performing
(e)TMF reviews, performing mass mailings and communications as needed,
providing documents and reports to internal team members.
Supports scheduling and organization of client and/or internal meetings with
completion of related meeting minutes.
Reviews and tracks local regulatory documents.
Transmits documents to client and centralized IRB/IEC.
Analyzes and reconciles study metrics and findings reports. Assists with
clarification and resolution of findings related to site documentation.
Maintains vendor trackers.
Assists with coordination, compilation and distribution of Investigator Site File
(ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
May attend Kick off meeting and take notes when required.
Qualifications:
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
Bachelor's degree preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at
least 4 years).
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:
Ability to work in a team or independently as required
Strong organizational skills and attention to detail, with proven ability to handle multiple tasks
efficiently and effectively
Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
Strong customer focus
Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet
changing project timelines
Demonstrated ability to attain and maintain a good working knowledge of applicable Country
Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all nonclinical/clinical aspects of project implementation, execution and closeout
Excellent English language and grammar skills and proficient local language skills as needed
Good presentation skills
Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain
knowledge and master all clinical trial database systems
Ability to successfully complete PPD clinical training program
Self-motivated, positive attitude with effective strong interpersonal skills
Management Role:
No management responsibility
Working Conditions and Environment:
Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to
electrical office equipment.
Occasional drives to site locations. Potential Occasional travel required.
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.
May interact with others, relating and gathering sensitive information. Interaction includes diverse
groups.
Works with guidance or reliance on oral or written instructions from management. May require
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. Ability to multi-task.
Regular and consistent attendance.