The Sr. CRA will design, plan and conduct high quality clinical research trials to ensure safety and effectiveness of Abiomed products.
Primary 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.
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.
Skills/Requirements
BS preferred in Life Sciences or Medicine (Cardiac RN, preferred)
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 to research sites at short notice
ABIOMED is an Equal Employment Opportunity/Affirmative Action employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.
