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

State CA

Description

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.

Essential Functions

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

Requirements

Minimum Qualifications

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

Experience:

  • 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.