Satellite Healthcare Research - Study Coordinator in San Jose, California
Requisition Number 18-0243
Post Date 3/29/2018
Title Research - Study Coordinator
Location Corporate HQT
Job Status Full Time
Work Hours 40
City San Jose
Satellite Healthcare is a successful, nonprofit organization that has improved the lives of people living with kidney disease since 1973. We earn our national reputation for excellent patient care each day by offering a complete range of dialysis therapy
choices, personalized clinical services, and unparalleled wellness education.
Satellite Healthcare provides expert, personalized kidney care at over 90 centers across the U.S. as well as at acute dialysis locations in California and Texas. Learn more about Satellite Healthcare at www.satellitehealth.com .
The Research Study Coordinator participates in the execution of research protocols as part of a safe, high quality, patient-oriented research agenda. The Research Study Coordinator undertakes the responsibilities for multiple sponsored research studies
and participates in internal research projects. Using diligence to details, knowledge of Good Clinical Practice (GCP), and previous research experience, the Research Study Coordinator maintains patient confidentiality, research integrity, and represents Satellite
research to the staff of Satellite Healthcare, Inc.
The essential functions listed are not a comprehensive inventory of all duties, tasks, and responsibilities. Employees may also perform other duties as assigned. All employees must work in accordance with Satellite’s I-CARE Standards.
Research study coordinator for internal research studies; assists in the development of research proposals for Satellite’s research program
Carries out correspondence with Independent Research Board (IRB), sponsor, and clinical sites
Designs and maintains organizational tools to conduct the study accurately and in compliance with GCP and protocol(s)
Ensures the safety and welfare of the study participants by identifying appropriate study subjects, screening for eligibility and obtaining proper written informed consent
Maintains strict adherence to study protocols by managing regulatory documents and case-report forms with keen attention to detail and deadlines
Conducts the clinical study according to FDA regulations and guidelines; trains other site personnel and medical staff in understanding and implementing the protocol
Utilizes a team approach when conducting a research project; communicates with appropriate center staff and patients regarding the research process, study protocols and procedures as appropriate; offers information, advice and assistance to center staff members in a positive, courteous and cooperative manner; reports all adverse experiences to the Principal Investigator
Meets with and communicates with the sponsor or delegates regarding study activities as necessary; attends investigator meetings to learn study requirements as required, represents the site and conveys all information to the site study team
Oversees appropriate staff per each research protocol to ensure lab specimens and tests are performed correctly
Documents in a clear, concise and thorough manner both in CRF’s and patients charts when needed; maintains adequate and accurate case histories for each study participant; appropriately prepares, records, files and maintains data for research protocols
Verifies the accuracy of all study protocols and information recorded
Recommends, in cooperation with the supervisor, changes in procedures when new knowledge indicates such a need
Follows all Satellite policies and procedures for infection control
Develops and/or participates in in-service education programs
Responsible for driving the Satellite Healthcare culture through values and customer service standards
Accountable for outstanding customer service to all external and internal customers
Develops and maintains effective relationships through effective and timely communication
Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner
Assumes responsibility for special research projects, as directed
Any combination of education and experience that would likely provide the required knowledge, skills, and abilities as well as possession of any required licenses or certifications is qualifying.
Education: High School Diploma, GED or equivalent
Three (3) months of patient care technician experience required
FDA or clinical experience required, specifically in dialysis, nephrology, or transplantation preferred
Prior training or experience in clinical research Good Clinical Practice (GCP) requirements and medical documentation requirements preferred License/Certification: Certified Research Coordinator (CRC) preferred *Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying. Knowledge, Skills & Abilities:
Understands basic research techniques, International Conference on Harmonisation (ICH) guidelines, and their impact on patient/subjects
Able to demonstrate sound judgment and skills in problem resolution and follow-through
Able to demonstrate understanding and tact in dealing with patients, physicians, visitors, family members, unit personnel and corporate staff
Able to read, write, speak, understand, and satisfactorily communicate in English
Proficiency with Windows, Microsoft Outlook, Excel, Access, and Word, and Internet
Able to work independently
Able to travel within Bay Area up to 20% of the time and able to adjust schedule to accommodate patient treatment times
Contributes to harmonious and constructive working relationships with all staff members to promote a positive and productive atmosphere
Satellite Healthcare, Inc. (SHC) strongly values diversity and is committed to equal opportunity and non-discrimination in all of its policies and practices, including the area of employment. Accordingly, SHC does not discriminate against any person on the basis of race, color, sex, sexual orientation or identity, religion, age, national or ethnic origin, political beliefs, marital status, medical condition, genetic information, veteran status, or disability. Women and men, members of all racial and ethnic groups, people with disabilities, and veterans are encouraged to apply. We offer a drug-free work environment.