Clinical Research Coordinator II

Job Title: Clinical Research Coordinator II

Reports To: Director of Research Administration

Location: Los Angeles, CA 90017

Job Status: Full Time

ROLE SUMMARY

The House Institute Foundation (HIF) is seeking one full-time Clinical Research Coordinator 2 (CRC). The HIF research department is co-located within the House Childrens Hearing Center (HCHC) in downtown Los Angeles, California. The CRC will manage IRB submission and renewals for a growing portfolio of research studies, including associated FDA documentation and correspondence. This is an opportunity to work on studies and with principal investigators that include basic science (genomics and proteomics), clinical trials (pharmaceutical sponsors), and translational research with real-world implications for individuals and families. In addition to supporting regulatory compliance, the CRC will facilitate 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. The majority of tasks can be performed remotely, but full-time access to the research program offices is available between 9am and 5pm M-F.

ABOUT HOUSE INSTITUTE FOUNDATION

The Institute is named for Dr. Howard P. House, a pioneering Otologist who, along with his brother 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, Menieres disease, auditory prosthesis, neurosurgery, and pediatric hearing health. In addition to the Director of Research Administration, the HIF research infrastructure includes two clinical research coordinators and a Hearing Science Accelerator (HSA) program coordinator. The coordinators provide support with IRB application and correspondence, recruiting and consenting participants, and data collection. The research program regularly engages talented undergraduates and consultants in extracting, cleaning, and building large datasets for secondary data analysis.

In July 2022 the HIF research program moved into a new space that includes private offices for research scientists, a sound booth dedicated to research, secure temperature-controlled storage, and workstations for research staff. The research program offices are co-located with the House Children's Hearing Center and House Hearing Health Center (adult hearing aid clinic). Located in downtown Los Angeles, it is adjacent to the House Ear Clinic at the PIH Health Good Samaritan Hospital.

In addition to the administration of external funds (NIH and foundation), the research program releases requests for funding proposals that leverage the donations from grateful patients and sponsors to support high impact research. As good stewards of the funds, and with a focus on robust science, proposals over $20,000 are externally reviewed through a process that emulates the rigor of an NIH review.

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
• Participate in weekly research team meetings, bi-annual faculty meetings, monthly research committee and staff meetings

QUALIFICATIONS

Clinical Research Coordinator II candidate must have:

• 3 years experience as a clinical research coordinator, including IRB submissions and interpretation/application of regulatory codes
• BA/BS degree
• Clinical Research Coordinator certification through SOCRA, ACRP or other professional organization
• Proficient in Microsoft Office, advanced Excel user
• Commitment to advancing HIFs mission
• Willingness to go above and beyond to contribute to the success of a dynamic team

Preferred Qualifications:

• MA/MS degree
• Project management certification
• Experience with the following:
• 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

Job Type: Full-time

Salary: $65,000.00 - $74,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Please submit a cover letter highlighting your professional experience as it relates to the job description and preferred qualifications section.

Education:

• Bachelor's (Required)

Experience:

• clinical research coordinator: 3 years (Required)

License/Certification:

• CRC certification (Required)

Work Location: Hybrid remote in Los Angeles, CA 90017

Flexible work from home options available.