Clinical Research Associate

Responsibilities:

Conduct site qualification, initiation, monitoring and closeout visits and create documentation of such through accurate and detailed visit reports
Review all source records for patient safety and ensure complete documentation of all subject safety events
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
Monitor source documents to EDC for completeness and accuracy through verification of subject records and source documentation. Verify that all subjects meet inclusion/exclusion criteria
Follow through after visit to outstanding requests/needs are fulfilled
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
Assist in organizing documentation for regulatory submission, including IDE and PMA FDA submission
Work closely with other CRAs for coverage in collecting and reviewing regulatory documentation and assuring consistency between RMF and site files
Responsible for accurate and timely oversight and maintenance of RMF

Skills and Experience:

Bachelor’s degree in a life science field and basic familiarity with medical terminology
At least 2-3 years relevant industry experience in clinical research environment
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
Approximately 50% travel that will vary over time, including limited international travel to Canada/Europe (able to obtain passport).

Successful candidate(s) will be required to comply with Insightec’s Vaccination Policy.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender/gender identity, age, disability, marital status, sexual orientation, national origin, veteran status, and any other legally protected status entitled to protection under federal, state, or local anti-discrimination laws.

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Clinical Research Associate

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