Job description
PURPOSE
Provide administrative support to clinical projects under direction of line manager and/or other designated clinical team members. Assists with general administrative functions as required.
Responsibilities
Assist Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for completeness.
Assist CRAs/iCRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
May perform assigned administrative tasks to support team members with clinical trial execution.
Required Knowledge, Skills And Abilities
Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesKnowledge of applicable protocol requirements as provided in company training
Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
Good written and verbal communication skills including good command of English language
Effective time management and organizational skills
Ability to establish and maintain effective working relationships with co-workers, managers and clients
Did You Know?
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.
Whatever your career goals, we are here to ensure you get there!
Job
Monitoring
Minimum Required Education And Experience
High or Secondary School diploma/certificate or country’s educational equivalent and 3 years administrative support experience; or equivalent combination of education, training and experience
Physical Requirements
Extensive use of telephone and face-to-face interactions, which require accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.
Occasional travel.
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