Satellite Healthcare Senior Research Study Coordinator in San Jose, California

Requisition Number 18-0683

Post Date 9/4/2018

Title Senior 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 Senior Research Study Coordinator conducts and manages multiple clinical research protocols on behalf of Satellite Research and Satellite Healthcare.

This role Collaborates with Principal Investigators, Vice President, Research, Director, Research Business Unit and Project Manager, Research and Satellite Healthcare staff to execute clinical trials. The Study Coordinator, Research performs evaluation of

study logistics, processes development, and identifies improvement action plan. The role is responsible for continuously monitoring for best practices, patient safety, quality health care, while delivering study objectives.

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.

  • Ability to support and manage multiple clinical research protocols.

  • Coordinate studies in all phases from start-up to study close-out.

  • Train and support Satellite Healthcare staff regarding established SOPs, Internal Processes and CRC responsibilities, and various research processes in compliance with GCP.

  • Assist in developing recruitment strategies and research education materials.

  • Perform subject screening, determination of eligibility, obtaining informed consents, study enrollment, ongoing subject monitoring and tracking study-specific milestones

  • Carries out correspondence with IRB, sponsor, and clinical sites. Maintains study files.

  • Completes and maintains case-report forms and regulatory documents with keen attention to detail and deadlines. Maintains strict adherence to study protocols.

  • Conducts the clinical study according to FDA regulations and guidelines. Trains other site personnel and medical staff in understanding and implementing the protocol.

  • Utilizes the team approach when doing a research project. Confers with appropriate unit staff regarding the research process. Communicates significant research study information to the appropriate unit staff members. Effectively communicates with staffand patients regarding research study protocols and procedures. Promotes a teamwork approach by offering information, advice and assistance to all unit staff members in a positive, courteous and cooperative manner. Reports all adverse experiences to the PrincipalInvestigator.

  • Communicates with the sponsor regarding study activities as necessary. Meets with the sponsor’s representatives to discuss the conduct of the study and review study data. Attends investigator meetings (as required) to learn study requirements, meets sponsorpersonnel, represents the site and conveys all information to the site study team upon return.

  • Accurately assesses patients’ ability to meet research protocol criteria. Assures that potential research candidates thoroughly understand and can complete informed consent process.

  • Assures lab specimens and tests are performed by appropriate staff per each research protocol.

  • 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 that records all observations and data during the study. Appropriately prepares,records, files and maintains data for research protocols.

  • Demonstrates sound judgment and skills in problem resolution and follow-through. Demonstrates understanding and tact in dealing with patients, physicians, visitors, family members, unit personnel and corporate staff. Recommends, in cooperation with thesupervisor, changes in procedures when new knowledge indicates such a need.

  • Knows and follows all Satellite policies and procedures for infection control. Understands the hazards associated with failing to follow those procedures.

  • Develops and/or participates in in-service education programs.

  • Participates in self and/or peer evaluations.

  • Assists in orientation of new staff members as directed by supervisor.

  • Participates in the execution of research protocols as part of a safe, high quality, patient-oriented research agenda.

  • The Study Coordinator undertakes the responsibilities for sponsored research studies and participates in internal research projects.

  • Using diligence to details, knowledge of Good Clinical Practice, and previous research experience, the Study Coordinator maintains patient confidentiality, research integrity, and represents Satellite Research to the staff of Satellite Healthcare, Inc.

  • 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

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: Minimum of 2 years of college plus 4-5 years of work experience

Experience:

  • Certified in a Clinical Research Operations program

  • Clinical experience, especially in dialysis, nephrology, or transplantation preferred

  • CITI Training

  • Experience with Clinical Trial Coordination and Procedural System Implementation

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.