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Clinical Operations Coordinator

Date:  Dec 2, 2022
Location: 

Danvers, Massachusetts, 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
 

Job Description:

The Clinical Operations Coordinator is responsible forsupporting efforts to effectively onboard new hires, ensure associates have access to and receive training to perform their assigned responsibilities, contribute to business process improvement and technology implementation/refinement initiatives, and provide routine support to the Clinical Operations and Compliance functions to conduct highly efficient and quality focused clinical trial execution. 

 

Primary Duties and Responsibilities:

  • Executes continuous activities to ensure ongoing health authority inspection readiness including but not limited to the following:
    • Management of role-based Training Plans/Curricula for internal and external study team members and leadership
    • Job Descriptions and Curriculum Vitae (CVs) are current, signed, and centrally stored
    • Training records are complete, accessible, and can be readily retrieved
    • Organization Chart is current and reflects appropriate titles
  • Maintains ongoing updates to the Quality System by ensuring Standard Operating Procedures (SOPs) are reviewed annually and updated if applicable.  Follows established change control procedures to update and submit SOPs for formal revision and approval.
  • Drives departmental onboarding of new associates to ensure they receive appropriate training and are effectively integrated into the organization and study team(s) they will support.
  • Supports Manager of Compliance with internal/external audits and quality reviews
  • Supports quality control review of clinical and regulatory documents to ensure consistent references, formatting, change control, branding, etc.
  • Assists with gathering business end user process requirements to support technology implementation/refinement activities.
  • Assists clinical trainers with managing training materials and gathering training completion logs.
  • Supports the development of job aides/training materials including business process mapping visualizations.
  • May support clinical study site payment tracking and reconciliation efforts as requested by leadership.
  • Assist with the design and application of assessment tools to measure training effectiveness. 
  • Track and report on training compliance to clinical management.
  • Evaluate and make recommendations regarding training material and methodology.
  • Manage and coordinate logistics for internal training activities including venues and equipment, as necessary.
  • Coordinate requests for clinical system access.
  • Maintains accurate and complete study records.
  • Ability to perform additional responsibilities as requested.

 

Job Qualifications:

  • Bachelor’s degree from an accredited university required; Preference will be given to candidates/individuals with a Bachelor of Science (BS) degree in Life Sciences or related medical/scientific/technical field.1
  • Minimum 2 years of professional experience in a CRO, pharmaceutical, biotechnology, or medical device company.1
  • Familiarity with 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.
  • High attention to details and accuracy; ability to work independently and to prioritize and organize work to meet deadlines.
  • Proactive and dedicated to continuous improvement.
  • Experience coordinating Clinical Training Programs and working with Clinical Training Systems strongly preferred.
  • Ability to travel ~10%.

1 An equivalent combination of education, experience and performance may be considered.

 

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.