The Sr. Clinical Research Specialist I will assist in designing, planning and conducting high quality clinical research trials and registries to ensure safety and effectiveness of Abiomed products.  

Job Responsibilities:

·       Implement clinical trial strategies and execute clinical trial protocols study objectives;

·       Ensure consistent study execution through the development of supporting study documents such as Clinical Investigation Plans, Case Report Forms, Data Management Plans, and Monitoring Plans;

·        Conduct clinical site management daily activities and monitor program metrics to ensure consistent and predictable study progress;

·       Actively identify issues and challenges that present barriers to program success and develop and implement appropriate solutions;

·       Conduct site initiation and study closeout activities and provide training to site personnel

·       Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures;

·       Create and review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team;

·       Track and report on progress of study including site activation, patient enrollment, monitoring visits;

·       Investigate issues, monitor discrepancies, and follow up until resolution;

·       Perform clinical data review, source data review, source data verification,  and including query generation;

·       Assist in negotiating budget, contract, and IRB/EC approval with sites and investigators.

·       Assist in identification and selection of investigation sites, and support the sites all along the study in close collaboration with other team members;

·       Follow-up the budget (forecast, engaged) related to the assigned clinical trial- Ensure that work is performed in accordance with scope of work in order to validate vendor invoices;

·       Assist with vendor training on protocols and procedures- Assist in identification and selection of appropriate vendors; and

·       Other responsibilities as assigned.

Experience:

·       Bachelor's or higher degree mandatory

·       8 years of clinical research trial experience with a Bachelor's degree; or 6 years with a Master’s degree; or a PhD with 3 years of experience

·       Balanced, flexible, humble, open minded, organized, patient, proactive, positive, results-oriented and team player.

·       Experience with on-site monitoring of clinical research trials

·       Experience direct management of clinical research investigational sites

·       Demonstrated ability to lead and mentor project team members

·       Experience in Class III cardiovascular device studies preferred

·       Ability to work on multiple protocols at the same time

·       Strong working knowledge of guidelines, systems for clinical trial management and of ICH, FDA, and GCP regulations and practices

·       Proven track record of having good investigator and site relations

·       Excellent interpersonal, verbal, and written communication skills

·       Attention to detail and strong organizational skills

·       Strong knowledge of Microsoft Office Suite and Outlook

·       Must be able to travel up to 25% overnight