Serves as primary point of contact for assigned clinical studies
Participates in project team meetings and provides clinical representation
Participates in identification, evaluation and selection of clinical study sites and
Develops or assists with the development of study design, protocol, case report form and other
study specific documents essential to the appropriate implementation of clinical studies
Coaches investigators to ensure optional compliance and performance to the protocol,
regulatory requirements, discrepancy reporting and/or ethical practice issues.
Assist with preparation and execution of Investigator meetings.
Ensures ICH and GCP procedures are followed in all study aspects Participates in vendor
Manages Clinical Project Managers and/or CRAs
Monitors overall trial through all phases
Ensures clinical data integrity by performing investigator/site training and source
Provides assistance to investigators by identifying issues, offering solutions, and following
Reads and critically interprets relevant literature.
Serves as a resource for clinical knowledge
Identifies issues that may impact the overall project plans and initiates contingency plans as
appropriate Provides clinical
support in working with the FDA Follows company
policies, procedures and SOP's.
Completes other duties as designated by supervisor