Provide administrative support to clinical projects and update clinical systems and databases. Assists with general administrative functions, as required, in support of Clinical Research Specialist and/or other designated clinical team members.
- Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), 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. Collaborate with Clinical Project Manager (CPM), CRS/iCRS, CRAs/iCRAs and RSU on 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 and completeness.
- Collaborate with CRS/iCRS, CRAs/iCRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Coordinate 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.
- Assist in training and orienting new staff. May act as a mentor for less experienced CTAs.
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
- 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
- Basic knowledge 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 proficiency in use of Microsoft Word, Excel and PowerPoint
- Effective 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 5 years applicable experience; or equivalent combination of education, training and experience
- 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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