The position is responsible for providing clerical,technical and administrative support to one or more business units or clientswithin Clinical Operations.
Provides overall study support to functional leadsto ensure the successful completion of project deliverables. Mentors and / ortrains less experienced staff.
Responsible for performing activities in compliancewith applicable Corporate and Clinical Operations Policies, Standard OperatingProcedures and Work Instructions
Assists Clinical Monitoring staff with sitemanagement activities, including serving as a Sponsor representative for siteson assigned studies, and communicating with sites to ensure compliance withprotocol requirements, study procedures and relevant guidelines
Creates and assists with maintenance of projectfiles, handles project correspondence
Participates in file audits
Prepares and maintains site manuals, referencetools and other documents
Maintains, updates, and inputs clinical trackinginformation into databases
Tracks incoming and outgoing clinical andregulatory documents and updates for investigator sites, studies, project team,or client
Manages shared mailbox, processes site requests androutes correspondence appropriately
Coordinates the ordering, packaging, shipping andtracking of site supplies and materials
Assists with coordination of team meetings, attendsmeetings and prepares accurate meeting minutes and action items
Routinely anticipates, identifies and resolvespotential issues and implements corrective actions, seeking guidance as neededto resolve more complex issues
Maintains overall awareness in the field ofclinical research, as well as assigned areas, by completing all necessary andassigned training.
May provide training or mentorship to more juniorlevel Clinical Operations Specialists (COS).
QUALIFICATION REQUIREMENTS (pleaseindicate if preferred’)
Associates degree preferred orequivalent
Experience in clinicalresearch / pharma / biotech or related field considered in lieu of degree
Good knowledge of medical terminology,clinical data, and ICH / GCP preferred
Ability to successfully prioritize andwork on multiple tasks
Strong attention to detail, accuracyand organizational skills
Excellent communication, presentation,and interpersonal skills
Ability to embrace new technologies
Minimal travel up to 10% may be required