The Clinical Research Associate monitors the progress of clinical studies at investigative sites or remotely for a number of clinical trials at multiple sites, ensuring compliance in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, all applicable regulatory requirements, and contractual requirements. They establish and maintain sound clinical data collection practices to ensure validity of studies. Participates in protocol development, site/investigator selection, study initiation and study close-out activities.
Duties and Responsibilities
Acts as liaison between project managers and research-site personnel.
Monitors the conduct of clinical trials and compliance with established timelines.
Oversee and conduct data management and related communication processes for the clinical trials.
Adheres to protocol regulatory requirements, good clinical practice regulations, and standard operating procedures.
Assesses the trial site and applicable personnel on an ongoing basis.
Ensures compliance with the patient-consent process.
Verifies the receipt, handling, accounting, storage conditions, and availability of clinical products under investigation.
Verifies compliance and quality of collected data.
Ensures compliance with regulations and procedures in the event of serious adverse events, major adverse events, unanticipated adverse device effects, serious adverse drug reactions.
Drafts an appropriate intervention plan for the avoidance of redundant errors and deviations.
Verifies investigator records and checks for consistency with the contents of sponsor files.
Work with the study statisticians to prepare statistical analyses and safety reports.
Review study documents including protocols, worksheets, CRFs, monitoring plans, statistical analysis plans, and investigator brochures.
Complete accurate data entry into the relevant data collection form.
Reconcile data from multiple sources.
Create and update study documents according to trial requirements.
Maintain regulatory documents and other files as applicable.
Assist with ordering, shipping and maintaining research supplies.
Performs other similar duties as assigned.
2 years of clinical monitoring experience or equivalent combination of education and experience
Knowledge of ICH and local regulatory authority regulations
1+ years of Cardiology experience (Preferred)
Both drug and device trial experience (Preferred)
Reads, writes and speaks fluent English.
Proficiency in the use of the Microsoft Office Suite and specialized software for electronic databases.
Excellent analytical thinking and troubleshooting skills.
Knowledge of clinical trials principle, methodology, and procedures.
Knowledge of all federal and state regulations and guidelines pertaining to the conduct of clinical trials on human subjects.
Well organized and detail oriented.
Ability to develop and deliver both oral and written presentations.
Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment.
Ability to establish data collection and management guidelines.
Ability to provide technical advice, guidance, and support to professional staff in area of specialty.
Working knowledge of ICH Guidelines and GCP.
Ability to work in a fast-paced, dynamic environment with a committed team.