Clin Trials Asst

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.

All responsibilities are essential to job functions unless noted as non-essential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

. Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International
Conference on Harmonization (ICH) guidelines
. Knowledge 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 coworkers, managers and clients

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.