Abiomed (NASDAQ: ABMD) is a pioneer and global leader in healthcare technology and innovation, with a mission of RECOVERING HEARTS AND SAVING LIVESTM. Abiomed CEO, Chairman, and President, Michael R. Minogue, has focused the company’s efforts on developing ground-breaking technologies designed to assist or replace the life-sustaining pumping function of the failing heart. The Company’s portfolio of products and services offer healthcare professionals an array of choices across a broad clinical spectrum. From the world’s first total replacement heart to the World’s Smallest Heart Pump, 1/100th the size of the heart with rapid and simple insertion, Abiomed is dedicated to finding ways to bring the most advanced and beneficial technology to patients and physicians.
Abiomed is looking for a Senior Clinical Research Associate who will conduct high quality clinical research trials to ensure safety and effectiveness of Abiomed products.
Principle Duties and Responsibilities:
Participate in site qualification, initiation, monitoring and close out process.
Oversees subject screening and enrollment at assigned clinical sites.
Track and report progress of studies including patient enrollment/screening, data collection, adverse event documentation, and FAQ’s.
Monitor on-going compliance to study protocols and site adherence to global regulatory guidelines.
Conduct site visits, as necessary acting as a company liaison, and working with clinical sites to resolve any site related issues quickly and effectively.
Oversee CRO and monitors to ensure proper adherence of protocol.
Mentor, train and assist field monitors with site management activities.
Identifies and gathers missing or incomplete data from the investigational sites.
Review Case Report Forms (CRF’s) for clinical content. May write patient narratives for review.
Assist Clinical staff with the development and implementation of corrective actions for addressing noncompliance issues at individual sites and across study.
Assist in the development and distribution of study-related documents including, CRF’s, study protocols, study manuals, and other study tools to investigational sites and review committees.
Assist in planning, preparing, and distributing materials for investigator and coordinator meetings, and for study-related training.
Collects and tracks regulatory documentation to ensure compliance at both the sites and Sponsor Central File.
May participate in presentation of protocols and other study conduct requirements at investigational sites.
Manage device accountability, inventory, and distribution.
Assist in query writing and resolution process, as required.
Assist Clinical staff in identifying sites to be audited by either Corporate Compliance or Clinical staff. Assists with study site audits.
Assist with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing SOP’s and Work Instructions.
BS preferred in Life Sciences or Medicine
5 – 8 years experience as a Clinical Research Associate,
Experience with Class III cardiovascular and device trials preferred.
Knowledge of FDA regulatory requirements.
Ability to keep patient and company data confidential.
Demonstrated ability to provide customized solutions for optimal data collection.
Comfortable in representing the company’s interests and interacting with customers at many levels.
Accomplished project management skills, including establishing milestones, preparing and tracking budgets, and problem solving.
Available to travel approximately 30% to research sites within the United Sates.
Located in Danvers, MA, conveniently located off of Route 128, and with operations in Europe, we are looking for motivated leaders who share our mission of Recovering Hearts and Saving Lives TM while leading the industry in technology and innovation. ABIOMED is the place to prove your ability to deliver results and join a world class team!
**ABIOMED is an Equal Employment Opportunity/Affirmative Action Employer: M/F/D/V