Clinical Research Coordinator Central Texas Clinical Research Austin, TX Job Details Full-time $55,000 - $70,000 a year 14 hours ago Benefits Health insurance Dental insurance Paid time off Vision insurance Life insurance Retirement plan Qualifications Patient question and concern management Vital signs Electronic health records (EHR) management Regulatory compliance Patient management software Research project coordination Medical administrative support ICH guidelines Communication with regulatory authorities for clinical trials Patient interaction Clinical quality assurance standards Good Clinical Practice (GCP) Clinical trial support in drug product development Ethical review application preparation Technical Proficiency FDA regulations Time management Full Job Description The Clinical Research Study Coordinator (CRC) manages the daily operational, administrative, and clinical logistics of multiple simultaneous complex clinical trials at our high-volume research site. Working directly under the Principal Investigator (PI), you will serve as the central hub connecting patients, sponsors, Contract Research Organizations (CROs), and medical staff. This role requires an agile professional capable of maintaining rigorous Good Clinical Practice (GCP) compliance, maximizing patient retention, and managing flawless high-density data entry in a fast-paced environment.

Responsibilities :

Patient Management & Clinical Execution Patient Recruitment:

Screen large-scale electronic health records (EHR) and databases to identify, target, and recruit qualified study candidates.

Informed Consent:

Guide candidates through the complex informed consent process, detailing study protocols, risks, and benefits in accessible language.

Visit Coordination:

Schedule and orchestrate high-frequency patient study visits, aligning procedures with strict protocol-mandated timelines.

Clinical Procedures:

Perform basic clinical tasks including blood draws (phlebotomy), vital signs tracking, ECGs, and sample processing or shipping.

IP Oversight:

Handle and account for Investigational Product (IP), tracking patient compliance and managing strict temperature logs for storage units.

Data Management & Quality Assurance EDC Entry:

Input dense, accurate source data into Electronic Data Capture (EDC) systems within standard 24-to-48-hour sponsor windows.

Query Resolution:

Collaborate closely with visiting Clinical Research Associates (CRAs/Monitors) to resolve data queries rapidly.

Audit Readiness:

Maintain comprehensive, audit-ready source documentation and Investigator Site Files (ISF).

Regulatory & Safety Compliance Safety Reporting:

Identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs) directly to the PI, sponsor, and Institutional Review Board (IRB) within mandated reporting windows.

Protocol Adherence:

Minimize protocol deviations; rapidly document, track, and implement corrective action plans if a deviation occurs.

Job Requirements :

Education & Experience Degree:

Formal education in Life Sciences, Allied Health, Healthcare Administration, or a closely related biomedical field preferred.

Experience:

Minimum of 2-3 years of direct experience coordinating human clinical trials at a site level (Phase I-IV experience preferred).

Certifications:

Current CCRC (ACRP) or CCRP (SOCRA) designation is highly preferred; BLS/CPR certification is required.

Skills & Knowledge Regulatory Compliance:

Complete proficiency with FDA regulations, ICH-GCP guidelines, and IRB submission processes.

Technical Savvy:

Hands-on experience navigating EHR systems, CTMS (Clinical Trial Management Systems), and various sponsor EDC platforms.

Soft Skills:

Outstanding time management, assertive query resolution, and an empathetic bedside manner for diverse patient populations.

Job Type:

Full-time Pay:

$55,000.00 - $70,000.00 per year

Benefits:

Dental insurance Health insurance Life insurance Paid time off Retirement plan Vision insurance

Experience:

Clinical Research:

2 years (Required) Ability to

Commute:

Austin, TX 78705 (Required)

Work Location:

In person