Clinical Research Coordinator

Job Posting Title:

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Hiring Department:

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Position Open To:

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Weekly Scheduled Hours:

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FLSA Status:

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Earliest Start Date:

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Position Duration:

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Location:

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Job Details:

General Notes

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:

• Master’s degree in clinical research, Public Health, or a related field.
• Minimum of 5 years of experience in clinical research coordination.
• Certification as a Clinical Research Coordinator (CCRC) or equivalent.

LICENSES, REGISTRATIONS OR CERTIFICATIONS

Required:

• Certification as a Clinical Research Coordinator (CCRC) or equivalent.

Preferred:

• Additional certifications in clinical research or related fields.

WORKING ENVIRONMENT/EQUIPMENT

·       Standard office equipment

·       Repetitive use of a keyboard

Working Conditions

• May work around standard office conditions
• May work around biohazards
• Repetitive use of a keyboard at a workstation
• Field work as necessary

Required Materials

• Resume/CV
• 3 work references with their contact information; at least one reference should be from a supervisor
• Letter of interest

Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded.  Once your job application has been submitted, you cannot make changes.

Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.

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Employment Eligibility:

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Retirement Plan Eligibility:

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Background Checks:

A criminal history background check will be required for finalist(s) under consideration for this position.

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Equal Opportunity Employer:

The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions.

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Pay Transparency:

The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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Employment Eligibility Verification:

If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form.  You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States.  Documents need to be presented no later than the third day of employment.  Failure to do so will result in loss of employment at the university.

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E-Verify:

The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university’s company ID number for purposes of E-Verify is 854197. For more information about E-Verify, please see the following:

• E-Verify Poster (English and Spanish) [PDF]
• Right to Work Poster (English) [PDF]
• Right to Work Poster (Spanish) [PDF]

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Compliance:

Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031.

The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701.