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Sr. Clinical Trial Coordinator 1

Date:  Sep 16, 2022
Location: 

US

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, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 2,000 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 Recovery
 

The Senior Clinical Trial Coordinator (Sr. CTC) supports various aspects related to the planning and coordination of a clinical trial. The Sr. CTC will work collaboratively with project teams to ensure the trial maintains compliance with ICH/GCP guidelines, federal regulations, and corporate policies and procedures. Successful candidates will have experience working in a fast-paced environment with high attention to detail and organizational skills. The ability to anticipate and prioritize the needs of a clinical trial will be necessary. Excellent verbal and written communication skills are essential. A Sr. CTC is expected to deliver trial-related tasks independently, while also providing guidance and mentorship to other team members. The role involves interaction with internal and external partners and must operate with a high degree of discretion to handle information of a confidential and critical nature.

 

Primary Duties and Responsibilities:

  • Plan, coordinate, and arrange study communications on and off-site with both internal and external partners.
  • Responsible for supporting the drafting of meeting agendas and detailed meeting minutes.
  • Support site start-up activities including reviewing study specific ICF templates, managing and communicating the status of sites and study’s start-up progress.
  • Support Trial Master Files management, including set up, maintenance and study close out. Assures collection of essential clinical trial documents (i.e., CVs, Medical Licenses, Laboratory documentation, Financial Disclosures, Investigator Agreements).
  • Maintain quality of collected regulatory documents, which include a precise QC process and proper review in accordance with Good Documentation Practices (GDP) when documents are received.
  • Communicate with investigator sites on collection of regulatory documents, Institutional Review Board submissions and other trial-related information.
  • Create, review and distribute study materials and templates as required per assigned studies.
  • Collaborate with multifunctional teams to resolve issues on collected essential documents as required per assigned studies.
  • 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.
  • Maintain accuracy of clinical trial registration information.
  • Provide assistance with communication and coordination for trial committee interactions, as needed.
  • Provide support during audits and inspections, as applicable.
  • Support the training and onboarding activities of other Clinical Trial Coordinators.
  • Perform other trial-related activities, as assigned.

 

Job Qualifications:

  • BS degree with 3-5 years relevant clinical research experience (or equivalent) working at an Investigator Site, Sponsor or Clinical Research Organization.
  • Familiarity of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements.
  • Experience in clinical study start up is required.
  • Experience working with eTMF and CTMS systems is strongly preferred.
  • Experience working in medical device industry preferred.
  • Ability to work in a fast-paced team environment across multi-functional areas.
  • Highly organized, excellent prioritization, self-motivated, detail-oriented and proactive.
  • Demonstrate excellent communication, verbal and written, and interpersonal skills.
  • Demonstrate advanced proficiency in MS Office Suite: Word, PowerPoint, and Excel.

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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. Abiomed maintains a drug-free workplace.