Clinical Trial Coordinator 1
Posted on: June 12, 2021
Abiomed is a pioneer and global leader in healthcare technology
and innovation, with a mission of Recovering Hearts & Saving Lives.
With corporate headquarters in Danvers, Massachusetts, offices in
Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700
employees form one of the fastest growing medical device companies
in the world. We attract and retain exceptional talent with our
collaborative culture, passion for our work, and a strong
commitment to employee professional development.
Patients First | Innovation | Winning Culture | Heart
The Sr. CTC supports the Associate Director, Clinical Programs
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
currency 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
- 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
- Create, populate, review, approve, distribute and track study
materials as assigned by the Clinical Project Manager and Clinical
- 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
- 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
- Provide general office support of technical and non-technical
- 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.
- Under guidance of Clinical Operations management, interact with
internal and external clients to coordinate the accomplishment of
- BS degree with 2-3 years relevant clinical research experience
working at an Investigator Site, Sponsor or Clinical Research
- Familiarity of clinical trial operations, ICH, GCP Guidelines
and other applicable Regulatory requirements.
- Good working experience in a team environment across
- Highly organized, self-motivated, detail-oriented, proactive
- Ability to work with urgency and thrive in a high-energy,
- Demonstrate excellent communication, verbal and written, and
- 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
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
Nearest Major Market: Boston
Keywords: Abiomed, Boston , Clinical Trial Coordinator 1, Other , Danvers, Massachusetts
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