Clinical Research Assistant Jobs in Austin, TX

Job Summary

The Clinical Research Coordinator (CRC) is responsible for the coordination, implementation, and management of clinical research studies conducted within Child Neurology & Consultants of Austin. The CRC serves as the primary liaison between investigators, sponsors, contract research organizations (CROs), institutional review boards (IRBs), study participants, and clinic staff. Responsibilities include subject recruitment, informed consent, study visit coordination, data collection, regulatory compliance, sponsor communication, and maintenance of study documentation. The CRC ensures that all research activities are conducted in accordance with Good Clinical Practice (GCP), FDA regulations, sponsor requirements, and applicable institutional policies.

Key Responsibilities

Study Start-Up & Regulatory Compliance

• Assist investigators in study feasibility assessments.
• Coordinate study start-up activities.
• Prepare and maintain regulatory binders.
• Submit documentation to IRBs.
• Maintain investigator credentials, licenses, training records, and delegation logs.
• Ensure compliance with FDA, HIPAA, GCP, ICH, and sponsor requirements.
• Prepare for sponsor audits and regulatory inspections.
• Maintain all essential study documents.

Participant Recruitment & Enrollment

• Identify potential study participants through chart review and physician referrals.
• Conduct participant screening activities.
• Explain study participation requirements.
• Coordinate and document informed consent and assent procedures.
• Maintain participant recruitment logs.
• Track enrollment targets and study milestones.
• Facilitate participant retention throughout the study period.

Clinical Research Operations

• Schedule and coordinate study visits.
• Perform protocol-required procedures within scope of training.
• Collect study-related medical history and clinical information.
• Coordinate laboratory testing, imaging, EEG studies, sleep studies, and other protocol-required procedures.
• Maintain accurate source documentation.
• Ensure protocol compliance during all study visits.
• Coordinate investigational product accountability when applicable.

Data Collection & Study Documentation

• Collect and record study data accurately and timely.
• Complete case report forms (CRFs) and electronic data capture (EDC) systems.
• Resolve sponsor and monitor data queries.
• Maintain source documentation.
• Ensure data integrity and confidentiality.
• Assist investigators with study reporting requirements.

Safety Reporting

• Identify and document adverse events (AEs).
• Report serious adverse events (SAEs) according to sponsor and regulatory requirements.
• Assist investigators with safety assessments.
• Maintain safety reporting documentation.
• Ensure timely submission of required reports.

Sponsor & Monitor Relations

• Serve as primary contact for sponsors and CROs.
• Coordinate monitoring visits.
• Facilitate site initiation visits, interim monitoring visits, and closeout visits.
• Provide requested study documentation.
• Participate in investigator meetings and sponsor training sessions.

Financial & Administrative Responsibilities

• Track research participant stipends and reimbursements.
• Assist with study budget tracking.
• Support research billing compliance activities.
• Monitor study milestone payments.
• Maintain research-related invoices and sponsor documentation.
• Assist leadership with research program growth initiatives.

CN&CA-Specific Responsibilities

• Coordinate pediatric neurology clinical research studies.
• Support epilepsy, headache, sleep medicine, neuromuscular, developmental neurology, and other pediatric subspecialty research initiatives.
• Coordinate research visits alongside routine clinical appointments whenever possible.
• Collaborate with EEG, Sleep/LTM, Infusion, Nursing, and Physician teams to facilitate protocol-specific study activities.
• Assist in identifying future research opportunities for CN&CA patients and providers.

Qualifications

Education

• High School Diploma or GED required.
• Associate or Bachelor's degree in healthcare, biology, nursing, public health, psychology, or related field preferred.

Experience

• Minimum two years of healthcare experience preferred.
• Prior clinical research experience preferred.
• Experience with pediatric populations preferred.
• Experience coordinating clinical trials preferred.
• Experience with EHR systems and research databases preferred.

Certifications

• Certified Clinical Research Coordinator (CCRC) preferred.
• Certified Clinical Research Professional (CCRP) preferred.
• Good Clinical Practice (GCP) Certification preferred.
• Human Subjects Protection Training preferred.

Skills & Abilities

• Strong understanding of clinical research processes.
• Knowledge of FDA, ICH-GCP, HIPAA, and IRB requirements.
• Excellent organizational skills and attention to detail.
• Strong interpersonal communication skills.
• Ability to maintain confidentiality.
• Ability to manage multiple studies simultaneously.
• Strong computer skills including EHR and EDC systems.
• Ability to work independently and collaboratively.
• Strong problem-solving and critical-thinking abilities.
• Commitment to patient safety and ethical research practices.

Physical Requirements

• Ability to sit, stand, and walk for extended periods.
• Ability to lift up to 20 pounds occasionally.
• Ability to utilize computers and office equipment for extended periods.
• Ability to travel between office locations as needed.
• Ability to interact directly with pediatric patients and families.

Other Duties

Performs additional duties and responsibilities as assigned by the Medical Director, Practice Administrator, or Practice Leadership.

Pay: From $26.00 per hour

Expected hours: 40.0 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person