Clinical Research Associate (in-house)

Benefits

Qualifications

• •Bachelors degree or higher
• •3 or more years industry experience from Pharmaceutical, Biotechnology or Contract Research Organization (CRO), to include at least 1 years of site or hospital experience
• •Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
• •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
• •Strong verbal and written communication skills required
• •20% - 30% travel may be required
• •5 more items(s)

Responsibilities

• •The Clinical Research Associate (CRA) supports moderately complex clinical trial activities in support of the Clinical Trial Manager(s)
• •The CRA works closely with the clinical trial team to ensure site related start-up through close-out activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's
• •The CRA may assist with vendor oversight and management
• •They will identify issues in a timely manner and escalate to management as appropriate
• •The CRA may complete monitoring visit report review and perform co-monitoring
• •Organizes, and supports trial managers, in conduct of all study team via agenda and meeting minute preparation, completion and distribution
• •Manages Site Essential Documents review during study start-up, maintenance and close-out period
• •Prepare study documents (i.e
• •consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
• •Ensures tracking and filing of essential documents in the appropriate tracking systems
• •Ensures tracking of patient status throughout the study at investigative sites
• •Responsible for maintaining internal tracking systems of patient and site status in support of trial and management needs
• •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
• •Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
• •May assist in the preparation of, and may present at investigator vendor meetings and workshops
• •Actively involved in the performance of study feasibility assessments
• •Provides rapid action to address both internal and site QA findings from audits
• •Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
• •Routinely participates in department and clinical trial team meetings and participates in collaborative efforts (e.g. protocol development, CRO selection, departmental initiatives, etc.)
• •18 more items(s)