Clinical Research Coordinator
Masimo - Irvine, CA

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Masimo

(NASDAQ: MASI) headquartered in Irvine, California, is a fast-growing and award-winning international medical technology and device company with operations spanning the globe. We develop innovative, noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. These revolutionary technologies are helping to solve "unsolvable" problems that have plagued the healthcare industry, while taking the pain and discomfort out of blood monitoring. For more than 20 years, innovation has been and will continue to be our passion.

To learn more about us, please visit: www.masimo.com

Job Summary:

The Clinical Research Coordinator is responsible for a variety of administrative duties in support of the Clinical Research Department, where all activities are conducted in accordance with Government Regulations (FDA, MDD and International), Good Clinical Practices (GCP), Department Operating Procedures (DOP).

Reporting Relationships:

This job reports to: Director of Clinical Research. Reporting directly (or indirectly) to this position are the following job titles:

Not Applicable

Duties & Responsibilities:

Research Study and Supply Coordination:
  • Organizes and files, electronic and paper format, all investigator correspondence, protocols, equipment loan agreements, contracts, shipments, invoices, product returns, etc. in management of a study;
  • Orders products for study, prior to shipment checks products for accuracy and completeness, records equipment shipped into tracking database, assists clinical staff with packing and organizing study supplies, managing shipments (must lift and carry up to 20 pounds) to research sites in a timely manner, and processes, records and moves returned equipment back to stock;
  • Has sufficient understanding of product function to confirm equipment is operational and functional prior to shipment, and record devices serial #s and software revisions;
  • Ensures all research documents are correct, current, and filed appropriately for investigator, both paper and electronic forms;
  • Maintains tracking database of all active and inactive research sites, including modifying forms and creating reports as needed;
  • Prepare study applications for submissions to IRBs, organizing and filing critical correspondence, contracts, renewals, documentation of approved studies in documentation control, and same for all investigators participating in trial;
Department Administrative Support:
  • Enters all Clinical Research Agreements, NDAs, Consultant Agreements into company Contracts Database (ICRATS);
  • Creates purchase orders, check requests and invoices for all department payables, processes invoices through confirmation, approval, tracks payments through accounting, and tracking payments per budget allocation for calendar year;
  • Supports staff where needed with meeting organization, travel, expense reports and the like as needed;
  • Assists Speaker Bureau Manager with arranging travel, hotels for Speakers;
  • Assists with organization and management of medical affairs advisory meetings, focus groups, and guest speakers program;
  • Support multiple medical affairs functions, communicating with and managing key relationships and contracts for clinical affairs group;
  • Support multiple medical affairs functions, communicating with and managing key relationships and contracts for clinical affairs group;
Publication Management:
  • Conducts ongoing, or as needed, searches for medical literature, assists colleagues from other teams with literature searches for product planning, development, and marketing;
  • Responsible for the timely dissemination of journal publications on topics relevant to Masimo technology and market to Masimo research and marketing management;
  • Maintains company bibliographic database (Endnote);
  • Tracks abstract and panel discussion deadlines for all major conferences and reports upcoming deadlines to management;
  • Maintains publication tracking system for submitted, published abstracts and manuscripts;
  • Performs other duties or special projects as assigned;

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:
  • Strong computer skills with MS word, Excel, PowerPoint;
  • Very comfortable and competent with Internet based search operations;
  • Familiar with medical and scientific terminology;
  • Skilled and knowledgeable in organizational policies, practices and procedures to streamline departmental processes;
  • Excellent interpersonal & communications skills;
  • Detail oriented and able to handle multiple projects and timelines;
  • Works well under pressure to meet aggressive deadlines;
  • Ability to work across functions, and learn internal organization and functions needed for support;
  • Good listener, patient, flexible and energetic;
  • Excellent organizational skills, communicative and team-player, and willing to create processes understandable across department;
  • Very reliable with strong work ethic and dedication to job;
  • Must be able to pack or unpack boxes containing clinical research equipment and supplies for clinical research sites, may require lifting up to 20 lbs. on a regular basis;

Preferred Qualifications:
  • Understanding of Good Clinical Practice is preferred, but not required;
  • Knowledge of or willingness to learn databases used for tracking studies;

Education:

High school diploma or GED is required. Bachelor’s degree, preferably in a scientific, medical or related field is desirable.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Must be able to lift and carry up to 20 pounds in order to load and unload equipment and supplies into boxes for shipment to or returns from sites. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

We are proud to offer if eligible a highly competitive compensation plan with an excellent benefits package including 3 weeks vacation, stock options, 401k match, medical, dental, vision plans and much more!

Masimo is proud to be an EOE, M/F/D/V, and we value and are committed to Diversity at every level.

***NO AGENCIES PLEASE*** Thank you!

Masimo - 8 months ago - save job - block
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About this company
6 reviews
As important as the blood running through your veins is the oxygen it carries. Masimo knows that and makes tools that monitor arterial...