Research Study Coordinator
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 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.
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.
- 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.
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; m inimum 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
License/Certification: Certified Research Coordinator (CRC) preferred
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
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