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

Not a limited position.

Purpose

The Clinical Research Project Manager will serve as liaison between PIs, sponsors, coordinating centers, research participants, other study team members, regulatory bodies, study site managers and the Associate Director of Research. The majority of the job entails conducting study oversight to ensure research projects run smoothly and meets the research objectives within the specified timelines.

Responsibilities

Research Project Management

• Work under the guidance of the Associate Director and principal investigators to meet research study objectives. Provide day-to-day project management and coordination for multiple studies, which may vary in scope and clinical area. Manage the research team to ensure that all study activities are completed according to applicable regulations and guidelines and adhere to the protocol and Good Clinical Practice. Develop and oversee execution of recruitment strategies to ensure recruitment goals are met. Develop, organize, and maintain study databases and ensure data is complete and accurate. Help to facilitate project collaborations and teamwork. Maintain broad organizational perspective to effectively carry out internal and external relationships of the program. Coordinate and collect Texas Biologics pilot research project biospecimen samples. Oversee the collection and maintenance of appropriate source documentation and ensure accurate entry into study specific databases. Manage, document, and report on adverse events, compliance, and other participant related safety issues. Collaborate with investigators to ensure proper conduct of all aspects of clinical research. Implement and recommend policies and procedures to ensure compliance of all applicable laws, University policies, rules and regulations. Develop instructional materials to aid new physician investigators with study development and start-up requirements. Oversee the creation and maintenance of research protocols on the clinicaltrials.gov website. Assist with development of QI projects for hospital medicine. Screen, recruit, and enroll eligible patients and track participation over time. Conduct and manage study visits and participant assessments/interviews, which may include collection of biological specimens. Act as primary contact for study participants. Participate in data collection, data entry, and data organization. Manage the consent of participants and completing study visits with participants. Perform Quality Assurance/Quality Control of study data.

Research team support

• Recruit and manage research staff and learners across all research projects (research assistants/ research coordinators). Supervise the career development and training of research staff. Assist with manuscript preparation and editing. Maintain working relationships with other study teams internal and external to UT. Support the development and submission of grant proposals, publications, presentations, reports, and other study-related documents. Enter data and perform literature searches, administrative duties, and additional tasks as needed. Prepare presentations and help draft and submit manuscripts. Assist with developing grant proposals, including submission and reporting processes. Draft and facilitate institutional review board (IRB) applications, submissions, and updates. Assist in preparing study progress reports. Actively participate in research department meetings and events. Liaise with the Office of Research (OOR) as necessary; advocate for and use updated research resources posted on the intranet. Support other pilot projects as prioritized and time allows.

Regulatory Management

• Design Regulatory binders for the studies and oversee maintenance for the duration of the study. Manage the distribution of methods and instruments, conducting surveys, chart abstraction, maintaining regulatory compliance, collecting biospecimens, performing laboratory processes. Identify staff, patient, and system issues that impact participants and implement resolutions to better serve study participants. Participate in and facilitate study team meetings as well as trainings for the study team. Create, review and submit NDAs, MTAs, DUAs and other contracts on behalf of the PI, which may include but not limited to: formatting, documentation, reporting, project summaries/reports/analysis, review of expenditures, submissions, etc. Assist PIs Protocol Submission and Regulatory Compliance, including but not limited to: assisting PIs with IRB, IBC and Biosafety protocols, maintain EHS records for required personnel training, procedures, and reposting, submitting minor changes and annual reporting to institutional committees. Present at Research Nuts and Bolts on specific topic assigned. Provide lectures or other education to study coordinator and research support staff. Assist with special projects and any other tasks as related business needs arise. Oversee and assist in the management and development of faculty research budgets. Manage effort allocation of staff and insure accurate reporting and timely corrections.

• Other related duties as assigned.

Bachelor's degree with five (5) years' relevant clinical research experience, project administration/coordination, or Masters degree and three years related experience. Previous experience with subject recruitment and retention, and data management, and management experience within a large organization. Demonstrated ability to discuss personal topics with patients in a compassionate, sensitive manner. Demonstrated detail orientation, ability to follow-through, and strong problem-solving skills. Must possess effective project management skills, including the ability to plan, organize and schedule work in an efficient and productive manner, focusing on key priorities and meeting deadlines. Ability to work independently and on a team.Excellent written, oral, and interpersonal communication skills.Proficiency in Microsoft Excel, Word, and PowerPoint and willingness to learn other technologies as necessary. Finalist is required to complete Ascension Seton Research Affiliate application and UT Health Worklife Screening process; part of this involves proof of and/or completion of immunizations for our affiliates approval. Relevant education and experience may be substituted as appropriate.

Bilingual in English and Spanish. Experience working with REDCap, SmartSheet, Qualtrics, and other clinical trial EDCs. Experience assisting with grant submissions and administration of funds with sponsors such as NIH, NSF, PCORI, etc. Experience conducting research in UT Dell Medical School setting, Ascension Seton setting and/or Community Care setting.

OPEN

• May work around biohazards.

• Repetitive use of a keyboard at a workstation.

• Climbing of stairs.

• Occasional weekend, overtime and evening work to meet deadlines.

• Resume/CV

• 3 work references with their contact information; at least one reference should be from a supervisor

• Letter of interest

Importantfor 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 thatALLRequired 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 questionspresented 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 ,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 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:

• [PDF]
• [PDF]
• [PDF]
• [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 .

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