Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: Patients First. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomeds 1,300 employees form one of the fastest growing medical technology companies in the world. Abiomed attracts and retains exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
The Clinical Trial Coordinator (CTC) supports the Director, Clinical Operations and Clinical Program Managers in planning and coordinating activities in all aspects of clinical trial operations. This position requires appropriate interpretation of significant policies and procedures. It involves interaction with internal and external customers and partners, and must operate with a high degree of discretion, as the role involves handling information of a confidential and critical nature.
Principle Duties and Responsibilities :
- Plan, coordinate, and arrange study communications and critical meetings on and off-site with both internal and external attendees. Responsible for drafting Meeting Agendas and detailed Meeting Minutes for review and approval by Clinical Project Manager/Clinical Program Manager.
- Set up, update, maintain and close Trial Master Files. Assures recentness and accuracy of required clinical trials documents (i.e. CVs Medical Licenses, Laboratory documentation, Financial Disclosures, Investigator Agreements, etc.).
- Maintain project-specific regulatory document inventory systems which include a precise quality check (QC) process when documents are received.
- Maintain clinical grant tracking database for each study, generate periodic reports on status of grant payments and resolved payment inquiries from investigator sites.
- Communicate with investigator sites on collection of regulatory documents, Institutional Review Board submissions, and follow-up visit reminders as directed by Clinical Project Manager/Clinical Program Manager.
- Create, populate, review, approve, distribute and track study materials as assigned by the Clinical Project Manager and Clinical Program Manager.
- Accountable for accurate organization and maintenance of filing systems and tracking departmental documentation.
- Liaison to clinical and multifunctional teams to resolve issues with submitted essential documents required for trial activities.
- Create study materials, including newsletters, study templates, etc. under the direction of the Clinical Project Manager and Clinical Program Manager.
- Actively participate and contribute ideas in the development of department initiatives and goals that will make a difference in the efficiency and effectiveness of clinical operations.
- Plan, organize and perform a wide variety of responsible clerical duties.
- Provide general office support of technical and non-technical nature.
- Source and distribute study supplies.
- Regularly interact with high-level internal and external clients to coordinate the accomplishment of business needs.
- Support efforts for and/or prepare a variety of correspondence and complex PowerPoint presentations.
- Support the team to ensure timely invoice processing
- Under guidance of Clinical Operations management, interact with internal and external clients to coordinate the accomplishment of business needs.
- BS degree with 2 years relevant clinical research experience working at an Investigator Site, Sponsor or Clinical Research Organization.
- Familiarity of clinical trial operations, ICH, GCP Guidelines and other applicable Regulatory requirements.
- Good working experience in a team environment across multi-functional areas.
- Highly organized, self-motivated, detail-oriented, proactive and accurate.
- Ability to work with urgency and thrive in a high-energy, fast-paced environment.
- Demonstrate excellent communication, verbal and written, and interpersonal skills.
- Demonstrate advanced proficiency in MS Office Suite: Word, PowerPoint, Excel, Project and Publisher.
- Experience creating Clinical Trial Communications (newsletters, etc.), detailed PowerPoint presentations strongly preferred.
- Experience working with eTMFs and CTMS systems strongly preferred.
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.