Description
Responsibilities:Manages Site Essential Documents review during study start-up, maintenance and close-out period
Prepares study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
Ensures tracking of essential documents are received and filed in the CTMF, reviews site documents (including site-specific informed consent forms)for accuracy and follows up as needed
Ensures tracking of patient status throughout the study at investigative sites
Provides clinical team support with CTMF filing and management
Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
May review and approve trip reports, track data query reports, site visit metrics, and overall site performance
May perform routine monitoring at limited clinical sites
May perform site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with local CRAs
Assists in the preparation of, and may present at investigator vendor meetings and workshops
Actively involved in the performance of study feasibility assessments
Adheres to study timelines, quality, and budget for assigned studies
Provides rapid action to address both internal and site QA findings from audits
May coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
Routinely participates in department and clinical trial team meetings and may participate in collaborative efforts (e.g. protocol development, CRO selection, departmental initiatives, etc.)
Requirements:
Bachelors' degree or higher
4 years industry experience preferred, in a scientific or medical field, with at least 2 years working specifically on clinical trial coordination and site management
Previous Site monitoring experience
Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
Basic knowledge of therapeutic area or disease
Understanding of study phases and general knowledge of how they apply to clinical development
Advanced knowledge of Word, Excel, and PowerPoint.
Knowledge of the principles and practices of computer applications in database management
High degree of customer focus towards internal and external stakeholders.
Strong interpersonal and collaboration skills.
Strong verbal and written communication skills required.
Able to handle multiple tasks and deadlines.
Ability to identify issues and take appropriate actions.
10-30% travel may be required