The Research Study Coordinator is responsible for managing multiple clinical research trials
About Satellite Healthcare
Satellite Healthcare is more than simply a dialysis company. Since our founding in 1974, we have become the industry’s leader in personalized quality care: 70% of our centers earn 4- and 5-star ratings from Medicaid and Medicare.gov, far ahead of all other providers. Our success in caring for patients can be attributed to our mission, our not-for-profit structure, and our people. Together, they create a powerfully patient-centered organization.
Our mission is clear: to make life better for people living with kidney disease. Because we are a non-profit, we can pursue that mission with all our resources, united by our passion for patient care. As part of our commitment to continuous improvement, Satellite Research explores new ways to elevate the effectiveness and delivery of dialysis therapy. And Satellite Wellbound is leading the industry in home dialysis because better outcomes and quality of life are our highest priority. We are also substantial contributors to community and philanthropic kidney initiatives.
The Research Study Coordinator is responsible for managing multiple clinical research trials in accordance with Good Clinical Practice (GCP) and FDA regulations (if applicable) under the supervision of the Principal Investigator (PI). This role reports to the Manager of Clinical Programs and Research and collaborates with the Research Directors, Research Project Manager, other Research Coordinators and Satellite Healthcare staff to execute these clinical trials.The Research Coordinator is responsible for continuously monitoring for best research practices, quality data and completion of the study within the required timelines. The primary responsibility of the Research Study Coordinator is the safety and well-being of the patients on the clinical trial.
Ability to support and manage multiple research studies, both for internal research and contract (external) studies from startup to closeout
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 all FDA (as applicable), State and local regulations, GCP and the protocol(s)
In collaboration with the PI, ensures the safety and welfare of the study participants by identifying appropriate study subjects, screening for eligibility, accurately assessing the patient’s ability to understand and complete the informed consent process and obtaining and properly documenting the informed consent
Manages regulatory documents and case-report forms with keen attention to detail and deadlines
Must demonstrates an in-depth understanding of infection control and prevention of transmission of blood borne pathogens
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.
Documents and reviews all adverse events with the PI and notifies the PI immediately upon knowledge of any Serious Adverse Events along with notification of the Sponsor and IRB as appropriate.
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
Ensures that lab specimens and tests are performed by appropriate staff per each research protocol. If an outside lab is required, ensures that all lab specimens are collected, packaged and shipped per protocol under the Department of Transportation (DOT) and International Air Transportation Association (IATA) guidelines.
Documents in a clear, concise and thorough manner both in Case Report Forms (CRF) 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
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 Mission, Vision, and Values of Compassion, Trust, Quality, Innovation, and Teamwork. Employees must abide by all Satellite’s standards of patient care, patient’s rights and ethical treatment, and adhere to safety and quality programs.
Education & Experience:
High School Diploma, GED or equivalent. Minimum of 2 years of college preferred
Dialysis experience as an RN or at least 2 years’ experience as a PCT preferred
Prior training or experience in clinical research Good Clinical Practice (GCP) requirements and medical documentation requirements preferred
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, center and home office staff
Proficiency with Windows, Microsoft Outlook, Excel, Access, and Word, and Internet
Self-starter with the ability to manage multiple projects, meet timelines and adjust priorities as needed
Able to travel within the Bay Area to adjust schedule to accommodate patient treatment times. Occasional out of state travel may be required to attend Investigator Training Meetings.
Contributes to harmonious and constructive working relationships with all staff members to promote a positive and productive atmosphere
Able to read, write, speak, understand and satisfactorily communicate with others in English in person, over the phone and via email
Making life better for those with kidney disease is a mission you can embrace fully and passionately. You want to learn about your patients beyond just their time in treatment. You know the value of compassion, commitment and especially collaboration. You believe in continuous improvement as a way of looking at everything. You pursue goals with determination and build long and productive professional relationships.
What You Will Gain
Relationships: You will work directly with a multi-disciplinary team who are just as passionate as you about making a difference in others’ lives. You will also work alongside leaders who believe leading means serving; they support you in providing care that is unsurpassed in our industry.
Impact: The care you provide will enable our patients to live a better life that meets their needs holistically.
Growth: A Satellite career offers a lot of challenges, but also the support and leadership to learn and grow from each one. Here, the paths you find for fulfilling your aspirations don’t need to be linear if that’s your choice. With everything Satellite is doing to be a force for progress in the industry, you have many options before you.
Satellite Healthcare, Inc. is an equal opportunity employer. Satellite Healthcare, Inc. does not discriminate in employment on account of race, color, religion, national origin, citizenship status, ancestry, age, sex (including sexual harassment), sexual orientation, marital status, physical or mental disability, military status or unfavorable discharge from military service.
Satellite Healthcare – Improving the Lives of Patients with Chronic Kidney Disease (CKD)In 1973, Norman S. Coplon, M.D. began Satellite Healthcare with the objective of improving the quality of life of his dialysis patients. Dr. Coplon established Satellite Healthcare as a not-for-profit, community benefit organization, which allows us to focus primarily on patients. Four decades later, Satellite Healthcare has shaped CKD healthcare in our industry, and continues to elevate the standards of patient care and innovation. Today, we provide a range of expert services to patients with chronic kidney disease (CKD). Satellite strives to individualize each patient's care to help him or her enjoy their life to the fullest. Satellite Dialysis — We operate 40 high-quality, state-of-the-art, patient-friendly dialysis centers that meet the long-term clinical needs of more than 4,000 CKD patients. Satellite WellBound — With more than 20 centers in place, we focus on personalized training and support for patients performing dialysis at home. In addition, WellBound provides a robust complement of pre-dialysis patient wellness education programs that can help prevent or slow the progression o...f early stage CKD. At each of our centers, we put our patients first by providing: Compassionate care with a personalized touch Wellness education to empower longer, healthier lives - Best clinical practices resulting in outcomes that consistently exceed industry performance standards - Opportunities for nephrologists to focus on their patients in comfortable, state-of-the-art environments. In addition to patient care, our clinical research division works on finding medical breakthroughs for CKD patients by conducting both internal and external research. For more information, contact Info@SatelliteHealth.com.