About the job

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.

Requirements

Experience

• Typically requires a minimum of 2 years of experience. Less that than 2 years experience and student interns will be considered.

Knowledge\

• Requires basic job knowledge of systems and procedures obtained through prior work experience or education.

Education

• High School Diploma or equivalent

Additional Work Experience

• 3 years administrative support experience
• Or
• Equivalent combination of education, training and experience

Skills And Abilities

• Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Proficiency: Knowledge of applicable protocol requirements as provided in company training
• Proficiency: Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
• Proficiency: Good written and verbal communication skills including good command of English language
• Proficiency: Effective time management and organizational skills
• Proficiency: Ability to establish and maintain effective working relationships with coworkers, managers and clients

Awareness

• Frequently sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects.
• Frequently use hands and fingers to handle and manipulate objects and/or operate equipment.