logo

Clinical Research Associate

  • Anywhere

Company :
Leica Biosystems

Location :
San Diego, California

Expiry Date :
Tue, 15 Dec 2020 23:59:59 GMT

Apply Job :
Open Link

Description :
Leica Biosystems associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day. At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page Diversity and Inclusi is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We are looking for a Clinical Research Associate to prepare and execute clinical operations study tasks, including: documents (may include plan, protocol, report); initiation, monitoring, and completion of clinical studies for verification and/or validation. This position represents the Global Clinical Affairs group on multi-functional core teams to ensure project requirements are met and clinical trials are conducted successfully. Ensures adherence to Good Clinical Practice (GCP) and department standard operating procedures for conducting device clinical studies. As a Clinical Research Associate you will . . . * Under supervision of the Clinical Program Lead, works with relevant departments (R&D, Regulatory Affairs, Product Support, Program Management, Marketing) to aid in design and preparation of clinical and analytical performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms. * With minimum supervision, completes all activities related to the set-up, initiation, execution and close-out of device clinical trials including, site selection, collection and timely review and analysis of data generated. * Schedules and completes on-site monitoring visits to ensure protocol compliance, accuracy and completeness of clinical data. * Communicates with study investigators via phone, fax, email, onsite and/ or letters regarding activities in all phases of the study. Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials. * Leads the development, organization, implementation and completion of clinical studies according to FDA standards and Good Clinical Practice (GCP). Provides technical training and monitoring; coordinates daily activities of trial sites; assists sites on planning and implementing subject recruitment activities. * Educates and assists sites to ensure timely subject screening and enrollment * Conducts assessments of complications and serious adverse events, including reviewing and reconciling data and documentation related to the event. * Conducts quality control to ensure compliance to the study protocol, trial material storage and accountability. * Supports IRB submissions, addendums and renewals. * Provides technical support and training to clinical investigators and their staff in regard to device trial information, the protocol, clinical and regulatory requirements and device implant support. * Contributes to the submission of clinical data and study reports to support regulatory submissions. * Assists in evaluation and analysis of clinical data. * Remains current with regulatory requirements for in-vitro diagnostic and medical device products. * Completes the coordination with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure integrity of the database. * Provides up-to-date clinical study progress reports. * Negotiates site specific study budgets, initiates and oversees contract origination, compliance approval, and execution. Completes the tracking of budgets for studies. * Represents Global Clinical Affairs on multi-functional teams tasked with preparing responses to regulatory agencies. Required_Education,_Skills_And_Experience * Minimum of a Bachelor Degree in a related Scientific field or equivalent; minimum of two years’ related experience and/or training; or equivalent combination of education and experience. * GCP Trained; * Excellent communication skills, both verbal and written; * Excellent interpersonal skills, including negotiation skills; * Excellent organizational skills; Preferred_Skills_And_Experience * Knowledge of regulatory requirements for in-vitro diagnostic and medical device products; * Working knowledge of databases (e.g., Excel, Access), database management, and statistical applications; * Good knowledge of the in-vitro diagnostics and medical device industry preferred; * Good technical background to understand and communicate current and new technologies; * Laboratory experience is desirable; and, * Ability to work on multiple projects simultaneously. Travel * 30% -40% Travel Required; Remote position is based on West Coast for occasional travel to Vista, CA office. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here. Show moreShow less