Job Posting Title:
Clinical Research Associate II
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Hiring Department:
Department of Psychiatry
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Position Open To:
All Applicants
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Weekly Scheduled Hours:
40
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FLSA Status:
Exempt
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Earliest Start Date:
Jan 21, 2025
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Position Duration:
Expected to Continue Until Aug 31, 2025
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Location:
AUSTIN, TX
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Job Details:
General Notes
The Department of Psychiatry and Behavioral Sciences at the Dell Medical School is seeking a Clinical Research Associate II. This is a grant funded position with an end date of 8/31/2025, renewable based upon availability of funding, work performance, and progress toward research goals. This position will be assigned on-campus with an expectation to report to work on-site during the scheduled work week.
A successful candidate will possess the following knowledge, skill and abilities: attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; the ability to multi-task in a fast-paced environment while working with subject populations; ability to work well independently, ability to complete projects in a timely manner, and ability to prioritize multiple projects to ensure the completion of essential tasks by deadlines; excellent organizational skills; and excellent interpersonal skills to work effectively in a team.
Purpose
The Clinical Research Associate II will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI). This position may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, the University of Texas at Austin and regulating agency policies.
Responsibilities
Study Coordination and Data Collection: Support the management and coordinate the tasks of single or multiple clinical research studies, depending on their size and complexity. Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects. Schedule subjects for study visits and meet with them to administer questionnaires, collect medical history and perform study procedures. Maintain rapport and relationships with subjects to ensure effective communication and retention, respond to their needs, schedule follow-up appointments, and become their intermediary. Obtain informed consent, review information with subjects, and assess and advocate for patient safety throughout each protocol procedure. Oversee subject reimbursement and work to resolve discrepancies and issues. Work with staff to ensure procedures are completed, specimens are properly stored, required data is collected at visits while ensuring correct shipping and labeling measures. Coordinate, communicate, and network with other studies and technicians to ensure scheduling efficiency. Communicate with any affiliated groups. Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies. Implement needs assessments and recommendations for enhancements on participant coordination, data collection, data management, protocol adherence and study collaboration. Act as intermediary between services and departments. Assist PI in the training and oversight of lab volunteers. Report study progress to investigators.
Data Management and Reporting of Results: Collect data during subject visits and enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner. Manage database structure for each protocol, update databases to improve data analysis and management, and create new databases as needed. Create and maintain comprehensive data sets as requested by the PI. Maintain data collection forms for effective data collection, entry, and analysis. Manage investigator’s protocols in the Institutional Review Board (IRB) system, as well as renewals and modifications of protocol applications and the implementation of new studies. Perform queries and analysis in databases. Work with supervisor to maintain complete and accurate data in the study database and analyze the data as it becomes available. Assist with clinical research databank REDCap builds and maintenance. Facilitate manuscript and grant writing and submissions, with opportunities to lead and be included in publications. Oversee study data integrity, implement and maintain periodic quality control procedures, and manage and report on study results.
Protocol Submissions and Adherence: Enter all existing and new study protocols and seek assistance on maintaining all protocols in the system by communicating with IRB staff. Design and enhance case report forms and data collection forms as needed. Provide manuscript feedback. Continue to develop and maintain systems for assuring protocol adherence and data quality. Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance. Renew, modify, and submit IRB applications and protocols. Ensure that protocol applications are submitted in a timely manner. Serve as a liaison between IRB and study Investigators. Provide quality assurance checks to note if protocols or applications need to be modified. Evaluate protocols on an ongoing basis and implement improvements as needed. Participate in the review and writing of protocols to ensure institutional review board approval within University compliance. Help assure compliance with all relevant regulatory agencies. Interface with departments to obtain UT Austin approval prior to study initiation and maintain all regulatory documents. Participate in any internal and external audits or reviews of study protocols.
Quality Control Procedures: Oversee data integrity and initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management. Update and maintain a procedure manual documenting all study-related procedures. Help develop a plan to ensure consistency in data collection and data entry. Implement and maintain periodic quality control procedures
Perform other related duties as assigned.
Required Qualifications
Master's degree and no experience, or bachelor's degree and two years of related experience. Familiarity with engineering and/or scientific equipment ordinarily used in college laboratory work. Experience coordinating or administering a research project or program. Strong computer skills and experience with Microsoft Office software, including Word, Excel, and PowerPoint. Prior experience with REDCap and statistical software, such as R, SAS, SPSS. Prior experience working with children and families. Experience working with children and families affected by autism. Excellent written communications skills.
Relevant education and experience may be substituted as appropriate.
Preferred Qualifications
More than 2 years of recent, directly related work experience following degree completion, utilizing the techniques or methods required by the position. Research experience and/or training in qualitative and quantitative methods for at least 2 years (including undergraduate research experience). Prior experience in making presentations of research findings at scientific meetings. Social science or behavioral health research experience. Prior experience with clinical research such as, recruiting, collecting data, data entry, and good clinical practice. Familiarity with IRB and other regulatory directives. Prior experience with screening, interviewing, eliciting informed consent, and explaining study requirements to participants in clinical research studies. Completion of Human Subject Protection Training. Working knowledge of ASD assessments and current scientific research within the relevant field. Ability to abstract data from patient charts and transfer it to data collection forms or directly into databases. Experience working with electronic data form and electronic data capture
Salary Range
$45,000+ depending on qualifications
Working Conditions
May work around standard office conditions
Repetitive use of a keyboard at a workstation
Occasional weekend, overtime and evening work to meet deadlines
Occasional interstate, intrastate and international travel
Required Materials
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:
Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval.
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Retirement Plan Eligibility:
The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.
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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:
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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.
