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
or equivalent combination of education, training and experience