The Clinical Research Associate (CRA) position represents an opportunity to grow within an emerging medical device company. Solid knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP/ICH) and the appropriate regulations is required. A broad understanding of essential study documentation is critical. The CRA has broad exposure to clinical research tasks as a combination of in-house and field work. The CRA works closely with the Clinical Project Manager to support various aspects of a Clinical Trial and related regulatory activities.
Field CRA Responsibilities
" Conduct site qualification, initiation, monitoring and closeout visits and create documentation of such through accurate and detailed visit reports.
" Monitor source documents to electronic data capture system for completeness and accuracy through verification of subject records and source documentation. Verify that all subjects meet inclusion/exclusion criteria
" Review all source records for patient safety and ensure complete documentation of all subject safety events (100% source document verification).
" Review regulatory binder to ensure complete, accurate, and up-to-date regulatory compliance at the site.
" Ensure compliance with protocol and overall clinical objectives.
" Train site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasks.
" Ensure investigator involvement in the study and Institutional Review Board/Ethics Committee oversight.
" Follow through after visits to see that all outstanding requests/needs are fulfilled.
" Raise issues of significance to the appropriate level for resolution.
" Able to help site navigate informed consent issues and support Institutional Review Board approval process.Compilation of Regulatory Submissions
" Assist in organizing documentation for regulatory submission, as needed
" Create electronic copies of submitted documents
" File all regulatory correspondence in the Regulatory Master File
" Responsible for accurate and timely maintenance of both electronic and paper files
Set up and maintenance of Regulatory Master File
" Organize site study files
" Work closely with other Company CRA's for coverage in collecting and reviewing regulatory documentation, and assuring consistency between Regulatory Master File and site files.
" Generate and maintain study checklists as necessary and keeps accurate records of all essential study material(s).
" Responsible for accurate and timely oversight and maintenance of Regulatory Master File.
" Demonstrate expertise in understanding and managing clinical study documentation.
" Proper and timely filing of all relevant study documents and standardized filing across all studies, per applicable Standard Operating Procedures.
Required Knowledge and Skills
" Knowledge of and proficiency in spoken and written English is a MUST.
" Minimum of medical/healthcare-related University degree with basic familiarity with medical terminology
" Basic computer skills with proficiency in Microsoft Word and Excel required; PowerPoint and Database experience desirable
" Ability to foster relationships with clinical sites and colleagues
" Ability to support several projects simultaneously, a flexible working style and attention to detail are essential
" Able to work independently with excellent time management skills
" Excellent work ethic with the desire to be a valuable contributing team member
" At least 3-5 years relevant industry experience in a clinical research environment
" Approximately 50% travel that will vary over time, including international travel to other countries (Position requires a valid passport at all times).
Job Type: Full-time