Clinical Research Associate

2 weeks ago

Austin, Texas, United States Urology America, MSO Full time
Job Overview

At Urology America, MSO, we are dedicated to enhancing the well-being of patients and their families through compassionate, high-quality, and ethical healthcare.

Choosing a career with Urology America, MSO means committing to improving lives through a collaborative, team-oriented approach in an innovative, quality-focused, community-centered environment. Better Medicine. Better Care.

Position Summary:

An experienced Medical Assistant or Research Assistant is sought to support the expanding research division at Urology America, MSO. Research Assistant roles frequently evolve into Clinical Research Coordinator positions, providing numerous career pathways within the field. Research Assistants play a vital role in assisting the Clinical Research Team with participant recruitment, diagnostic evaluations, laboratory specimen collection, and communication with patients, study sponsors, and investigators, among other engaging research-related tasks. This position collaborates closely with Study Coordinators, the Clinical Research Director, Principal Investigators (PIs), and Sub-Investigators (Sub-Is) on various clinical research initiatives.

Key Responsibilities:

  • Adhere to Urology America, MSO's Standard Operating Procedures.
  • Comprehend and implement the specific requirements of each study protocol and informed consent documentation.
  • Collaborate with study coordinators and research team members to fulfill protocol-specific tasks and documentation.
  • Assist in clinical and protocol administration duties, including but not limited to:
    • Clarifying the purpose, risks, and benefits of clinical trial participation.
    • Timely and accurate screening of potential candidates.
    • Ensuring that study participants understand the information provided and consent to protocol requirements.
    • Obtaining and maintaining patient consent prior to any study-related procedures while upholding the highest ethical standards.
    • Providing instructions to patients to ensure adherence to protocol requirements.
    • Distributing study medications in accordance with protocol randomization guidelines.
    • Learning and understanding laboratory procedures and obtaining and processing study-related lab specimens as per study-specific manuals.
    • Utilizing approved source documents; gathering protocol-specific data to complete and maintain source documents and case report forms (including electronic data capture – EDC) in compliance with applicable regulations and sponsor requirements.
  • Conduct study-specific assessments and measurements, including but not limited to:
    • Vital signs
    • ECG
    • Urine Pregnancy Test
    • Uroflow, TRUS, urinalysis, cystoscopy
    • Photography and videography
  • Report any irregular readings and measurements to the Investigator and Lead Study Coordinator.
  • Package and ship laboratory specimens to designated study-specific locations.
  • Complete required training and ongoing education as necessary.
  • Maintain certifications and continuously update knowledge of FDA, GCP, ICH, federal and state regulations, etc.
  • Support and communicate with patients and their families as needed.
  • Utilize EMR and data management systems to complete EDC, eCRFs, locate patients, and maintain records.
  • Effectively communicate with potential trial candidates and gather metrics to monitor progress.
  • Acquire knowledge of relevant software/programs.
  • Collaborate closely with IRB and study sponsors, PIs, and Sub-Is. Attend necessary meetings and calls.
  • Assist in developing source documents and phone screening tools.
  • Manage ancillary supply inventory and assist with drug accountability.
  • Ensure HIPAA-compliant communication and confidentiality at all times.
  • Participate in site visits (site initiation visits, interim monitoring visits, close-out visits, etc.).
  • Assist study coordinators with essential study close-out procedures and documentation.
  • Perform other duties as assigned.

Qualifications and Skills:

  • Willingness to gain comprehensive knowledge and strictly adhere to all clinical study protocols.
  • Develop an understanding of and demonstrate Good Clinical Practices (GCPs), learning and complying with all FDA clinical trial and IRB regulations.
  • Minimum of 1 year of experience as a medical assistant or research assistant is required.
  • Urology-based clinical experience is preferred.
  • Proficiency in computer software, including Microsoft Office, EMR, and Practice Management systems, as well as study-specific EDC and IVRS systems.
  • Effective time management skills and the ability to prioritize tasks.
  • Excellent communication skills with the ability to interact with all levels of management, staff, and physicians in person, virtually, and in writing.
  • Flexibility to adapt to day-to-day job requirements to facilitate a successful workflow in the clinic.

Urology America, MSO provides a competitive benefits package to eligible employees, including:

  • Medical, Dental, and Vision Insurance
  • Short & Long Term Disability
  • 401(k) with Employer Contributions and Profit Sharing
  • Paid Time Off (PTO)
  • Group Term Life Insurance
  • Health Care & Dependent Care Flexible Spending Accounts
  • Health Savings Account
  • Employee Assistance Program (EAP)
  • Competitive Wages
  • Paid Holidays
  • No Weekends

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