FierceBiotech and FiercePharma Jobs
IVD Clinical Research Associate - MyRAQA, Inc.
Nov 23
Location: Bay Area, CACategories: Clinical
Website: http://myraqa.com
Position Description
MyRAQA, Inc. is a full-service IVD consulting firm that offers, regulatory, quality, development and clinical services. We serve a wide range of customers from stealth startups to industry-leading public companies.
Our clinical operations are growing and we are seeking a Clinical Research Associate to join our team. We are particularly looking for team members who have a passion for what they do, show an entrepreneurial spirit and possess the ability to adjust to dynamic opportunities.
Clinical operations are headquartered in the San Francisco Bay Area. Candidates should be willing to commute to the East Bay or Mid-Peninsula.
Because we are exclusively focused on IVDs, substantial IVD experience is a firm requirement. Applicants who are unable to demonstrate IVD experience will not be considered.
Responsibilities:
Assist with the development of study-specific informed consent forms, monitoring plans, CRFs, monitoring conventions, tracking forms, and other study related documents.
Assist in site selection, and pre-study activities to identify and evaluate potential investigators. Complete site evaluation for qualification/selection of potential investigators/sites and report to management as appropriate.
Assist with IRB submissions (Site and Sponsor).
Assist with vendor management.
Complete monitoring visits to ensure the integrity of clinical data and appropriate follow up procedures, including source document verification and Adverse Device Event reporting in accordance with appropriate regulations.
Develop patient enrollment strategies with the project team and study sites, as required.
Complete study site close-out visits.
Other duties and assignments as needed for the overall success of studies.
Requirements
AA, RN, BS/BA or equivalent with at least 5 years clinical trial monitoring experience in accordance with CFR, GCP and ICH Guidelines.
Substantial IVD experience, preferably 5 years or more.
Working knowledge of Good Clinical Practices.
Excellent verbal and written communication skills. Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills. Good command of written and spoken English language
Ability to travel both domestically and internationally as required and process visit reports effectively.
