Clinical Research Coordinator

utaustin

Austin (TX)

On-site

USD 60,000 - 80,000

Full time

6 days ago

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Job summary

Dell Medical School's Oncology Clinical Trial team seeks a Clinical Research Coordinator to coordinate trials, manage data entry, and ensure regulatory compliance. The ideal candidate will communicate effectively with participants, staff, and sponsors while maintaining meticulous study records.

Responsibilities include study coordination, data management, regulatory submissions to IRBs, and ensuring adherence to GCP guidelines.

Qualifications

Bachelor's degree in a health-related field required.
Minimum 3 years of clinical research coordination experience.
Strong knowledge of GCP and regulatory processes.
Experience with IRB submissions and study documentation.

Responsibilities

Coordinate day-to-day activities of clinical trials.
Enter, verify, and manage trial data with accuracy.
Prepare regulatory documents and IRB submissions.
Inform and consent study participants; schedule visits.
Collaborate with PI, staff, and sponsors; ensure compliance.

Skills

Data entry

Regulatory compliance

IRB submissions

Study coordination

Communication

Multitasking

Education

Bachelor's degree in health-related field

Master's degree in clinical research / public health

CCRC certification

Tools

EDC systems

IRB submission portals

Job description

Job Posting Title: Clinical Research Coordinator

Hiring Department: Dell Medical School

Position Open To: All Applicants

Weekly Scheduled Hours: 40

FLSA Status: Exempt from FLSA

Earliest Start Date: Immediately

Position Duration: Expected to Continue Until Aug 31, 2027

Location: AUSTIN, TX

Job Details

The Department of Oncology at Dell Medical School is seeking a Clinical Research Coordinator to join their Oncology Clinical Trial team. The ideal candidate will have strong organizational and multitasking skills, proficiency in data entry, and excellent communication abilities, which are essential for this role. Join us in making a difference in the lives of cancer patients through innovative clinical research and compassionate care.

Purpose

The Clinical Research Coordinator (CRC) is responsible for coordinating and managing clinical research projects under the direction of the Principal Investigator (PI). This role involves overseeing the daily operations of clinical trials, ensuring compliance with regulatory requirements, and maintaining accurate documentation. The CRC works closely with research participants, clinical staff, and external sponsors to facilitate the smooth execution of studies.

ESSENTIAL JOB FUNCTIONS

Study Coordination

Manages the day-to-day activities of clinical trials.
Ensures compliance with study protocols and regulatory requirements.
Coordinates participant recruitment, screening, and enrollment.
Maintains accurate and timely documentation of study activities.

Data Management

Collects, enters, and verifies clinical trial data.
Ensures data integrity and accuracy.
Prepares data reports for review by the PI and sponsors.
Manages electronic data capture systems.

Regulatory Compliance

Prepares and submits regulatory documents to IRBs and other regulatory bodies.
Ensure ethical approval for studies is maintained, from initial approval through amendments, annual renewals, and terminations.
Ensures adherence to Good Clinical Practice (GCP) guidelines.
Maintains regulatory binders and essential documents.
Coordinates audits and inspections.

Participant Interaction

Informs and consents study participants.
Schedules and conduct study visits.
Monitors participant safety and well-being.
Provides education and support to participants.

Collaboration and Communication

Communicates study progress and issues to the PI and research team.
Liaises with sponsors, monitors, and other external stakeholders.
Participates in team meetings and training sessions.
Facilitates effective teamwork and collaboration.

Other duties as identified by department

Marginal or Periodic Functions

Assists with grant writing and funding applications.
Participates in the development of study protocols and procedures.
Attend professional development workshops and conferences.
Provides mentorship and training to junior research staff.
Adheres to internal controls and reporting structure.
Performs related duties as required.

KNOWLEDGE/SKILLS/ABILITIES

Ensures accuracy in data collection and documentation.
Identifies and corrects errors promptly.
Maintains meticulous records.
Clearly conveys information to participants and team members.
Facilitates effective collaboration.
Provides clear and concise reports.
Manages multiple tasks and priorities efficiently.
Maintains organized study files and documentation.
Ensures timely completion of study activities.
Identifies and resolves issues that arise during studies.
Develop solutions to improve study processes.
Thinks critically and analytically.
Utilizes electronic data capture systems effectively.
Understands medical terminology and clinical research methods.
Adapts to new technologies and software.

EDUCATION & EXPERIENCE

Minimum Qualifications

Bachelor's degree in a health-related field.
Minimum of 3 years of experience in clinical research coordination/human-subject research experience (screening/consent, visit coordination, data entry, IRB submissions).
Relevant education and experience may be substituted as appropriate.

Preferred Qualifications