Job details
Clinical Study Coordinator Job Description:
This professional will report to Clinical Science and External Research (CSER) Leaders in the management of assigned clinical projects for the client to support the development of the evidence generation and dissemination strategy of assigned products.
S/he will manage activities with supervision consistent with level of experience.
S/he will be responsible for supporting clinical activities and other study-related tasks, as well as applicable department procedures.
The Clinical Study Coordinator will or may be responsible for:
Coordinating postmarket clinical studies, investigator-initiated studies (IIS), collaborative studies, and real-world evidence studies
Supporting Clinical Scientists in study management operations including contracting, filing, processing invoices, and supporting publication related activities
Scheduling meetings, accurately drafting and recording meeting minutes, and following-up on action items
Collaborating with Company Legal/Compliance and study Institution/Principal Investigator on contract request, development, negotiation, and execution
Working with global Medical/Clinical colleagues in daily management of research projects in countries outside of the United States
Using sound judgment to assure all clinical research activities are in compliance with Legal, Regulatory, and Company process requirements
Tracking clinical study milestones, invoices, and payments
Managing device orders, shipments, and returns
Maintaining the internal clinical evidence database and assisting with monthly literature reviews
Supporting Clinical Scientists with the management of Clinical Events Committees for assigned clinical studies
Performing other assigned duties, as needed Qualifications A minimum of a Bachelor's degree in relevant scientific discipline
At least 2 years of experience in the pharmaceutical/biotech/medical device/CRO industry required; experience with clinical study management and clinical research contract negotiation highly preferred
Medical device experience is preferred; cardiovascular experience is a plus
Effective time management, organizational and prioritization skills
Strong project management skills with meticulous attention to detail and accuracy
Professional verbal and written communication skills; experience interacting with external investigators preferred
Proven ability to collaborate in a cross-functional team environment while having the skillset and confidence to work independently, as needed
Must be reliable, and flexible in adapting to shifting business needs while contributing to a multidisciplinary and fast-paced working environment
Must be a highly motivated, responsible, fast-learner, and team-oriented collaborator willing to take ownership of his/her contributions to the advancement of the collective CSER goals and objectives
Proficient in Microsoft Office
This position is in Irvine, CA
9592705