Clinical Research Coordinator

JOB DESCRIPTION

Job Title:           Clinical Research Coordinator I or II

Reports To:       Director of Research Administration

Location:           1127 Wilshire Blvd, Suite 1620 Los Angeles, CA 90017

Job Status:       Full Time; Hybrid

ROLE SUMMARY

The House Institute Foundation (HIF) is seeking one full-time Clinical Research Coordinator (CRC). The HIF research department is co-located within the House Children’s Hearing Center (HCHC) in downtown Los Angeles, California. This is an opportunity to work on studies and with principal investigators in the field of hearing science with real-world implications for individuals and families. The CRC manages IRB submissions and renewals for a portfolio of research studies. In addition to supporting regulatory compliance, the CRC facilitates study visits and procedures from workflow development to implementation in multiple healthcare settings and electronic systems. While the position reports to the Director of Research Administration, scientific direction and oversight is provided by multiple principal investigators. The CRC will be required to be on-site for approximately 2 days per week scheduled around research study needs. Full-time access to the research program offices is available between 9am and 5pm M-F.

ESSENTIAL RESPONSIBILITIES

  • Manage IRB & FDA submissions and renewals
  • Develop and implement data collection tools and workflows
  • Query and run reports in Electronic Health Systems
  • Facilitate research participant appointments within multiple healthcare and research settings and electronic systems
  • Participate in all aspects of research, including development of workflows, informed consent process, data collection and cleaning, regulatory compliance, and manuscript preparation
  • Identify and order specialized medical supplies for research procedures
  • Coordinate regular meetings with PI (monthly minimum) and document meeting notes in SharePoint folder.
  • Respond to email, Teams messages, and phone calls within 48 hours (weekday).
  • Participate in research team meetings, bi-annual faculty meetings, research committee and staff meetings

Clinical Research Coordinator I

  • Contribute to research program infrastructure through development, implementation, and maintenance of regulatory files, policies, and standard operating procedures.
  • Responsible for at least five active research studies.
  • Proactively monitor and manage study budget and timeline.

Clinical Research Coordinator II

  • Contribute to research program infrastructure through development, implementation, and maintenance of regulatory files, policies, and standard operating procedures.
  • Responsible for at least five active research studies.
  • Proactively monitor and manage study budget and timeline.
  • Supervise CRC I and/or Interns.

 

QUALIFICATIONS

EDUCATION AND EXPERIENCE:

  • A. or B.S (Master’s degree preferred)
  • Project management certificate preferred.
  • Experience with the following is a preferred:
    • Neuro or hearing science research
    • Supervising research assistants and interns
    • Compiling and analyzing medical literature
    • Using electronic medical records for data mining
    • FDA submissions
    • Using RedCap or other electronic systems to capture structured data
    • Using R’ or SPSS for simple statistical analysis
    • Using data visualization software
    • Managing budgets and financial reporting
    • Scientific writing

Clinical Research Coordinator I

  • 1 year relevant experience

 Clinical Research Coordinator II

  • 3 years relevant experience
  • Research professional certification through SOCRA, ACRP or other approved organization

 KNOWLEDGE, SKILLS AND ABILITIES:

  • Study Coordination
    • Coordinate and manage all aspects of research studies, ensuring adherence to protocols, regulatory requirements, and timelines.
    • Collaborate with investigators, sponsors, and other stakeholders to plan and execute clinical trials effectively.
    • Monitor study progress, identify potential issues, and implement solutions to ensure the smooth conduct of research activities.
  • Participant Recruitment and Management
    • Screen, recruit, and enroll eligible participants into clinical trials.
    • Obtain informed consent from study participants and ensure their understanding of the research procedures.
    • Maintain accurate and up-to-date participant records, ensuring confidentiality and compliance with privacy regulations.
  • Data Collection and Management
    • Oversee the collection, documentation, and management of research data.
    • Perform data quality checks and resolve discrepancies in a timely manner.
    • Ensure data integrity and accuracy throughout the study duration.
  • Regulatory Compliance
    • Prepare and submit regulatory documents to ethics committees and regulatory agencies.
    • Maintain comprehensive knowledge of applicable regulations, guidelines, and standards related to clinical research.
    • Assist in conducting internal audits and ensure compliance with Good Clinical Practice (GCP) guidelines.
  • Collaboration and Communication
    • Collaborate effectively with multidisciplinary teams, including investigators, sponsors, research staff, and external partners.
    • Communicate study updates, progress reports, and issues to stakeholders in a clear and concise manner.
    • Provide support and guidance to other research staff as needed.
  • Be a self-starter and demonstrate an ability to solve problems and remove barriers to research goals and initiatives.
  • Ability to adapt and thrive in a fast-paced environment.
  • Willingness to go above and beyond to contribute to the success of a dynamic team.
  • Excellent interpersonal, written, and oral communication.
  • Advanced Excel User, proficiency in Microsoft Suite and basic computer skills.
  • A strong commitment to HIF’s values.

 

Salary Range:

CRC I: $55,000 – $64,900

CRC II: $65,000 – $74,900 

 

About HIF: 

Founded in 1946, the House Institute Foundation has been at the forefront of advancements in hearing health for the past 75 years. Our seminal contributions to prevention, treatment, education, research, and humanitarian efforts exemplify our threefold mission of research, education, and global hearing health, “so all may hear.”

 The Institute is named for Dr. Howard P. House, a pioneering Otologist who, along with hisbrother Dr. William “Bill” House, is responsible for some of the earliest work in the world toward development of surgery techniques, temporal bone research, the first standardized functional hearing test, and the first cochlear implant system.

The House Institute (including the name) has evolved over the decades. Distinct contributions and areas of emphasis characterize the generations of research and education. For example, research conducted at the Institute led to workplace noise regulations, pioneering work on auditory brainstem implants and in partnership with 3M the development of the first FDA approved cochlear implant for adults and children. The contemporary focus is on translational research, grounded in and inspired by the patient-physician relationship.

Our current research program supports clinical trials and five research centers specializing in acoustic neuromas/ neurofibromatosis type 2, Meniere’s disease, auditory prosthesis, neurosurgery, and pediatric hearing health.