Clinical Research Manager

Job Details

General Notes

The Department of Psychiatry and Behavioral Sciences at the Dell Medical School is looking for a Clinical Research Manager.

This is a grant funded position with an end date of 08 / 31 / 2025, renewable based upon availability of funding, work performance, and progress toward research goals.

Purpose

The Clinical Research Manager will serve as liaison between PIs, sponsors, coordinating centers, research participants, other study team members, regulatory bodies, study site managers and the Assistant Director of Research.

The majority of the job entails conducting study oversight to ensure research projects are financially sound, run smoothly and meets the research objectives within the specified timelines.

Responsibilities

Research Management

Work under the guidance of the Assistant Director of Research and principal investigators to meet research study objectives.

Oversee day-to-day clinical trials management and coordination for multiple studies, which may vary in scope and clinical area.

Manage the clinical trial 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.

Manage project collaborations and teamwork. Maintain broad organizational perspective to effectively carry out internal and external relationships of the program.

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.

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 clinical trials protocols and budgets and other study-related documents. Enter data and perform literature searches, administrative duties, and additional tasks as needed.

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.

Regulatory Management

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. Assist with PIs Protocol Submission and Regulatory Compliance, including but not limited to : assisting PIs with IRB, IBC and Biosafety protocols, maintaindrug storage records, study, records and EHS records for required personnel training, procedures, and reposting, submitting minor changes and annual reporting to institutional committees.

Assist with special projects and any other tasks as related business needs arise.

Financial / Operational Management

Oversee and assist in the management and development of faculty research budgets. Manage effort allocation of staff and ensure accurate reporting and timely corrections.

Track and report clinical trials financials to department leadership. Find opportunities to make clinical trials financially viable.

Work with Assistant Director of Research on all research initiatives, operations and administrative support including philanthropic, psychedelic and research team support.

Other related duties as assigned.

Required Qualifications

Bachelor’s degree and six (6) years’ of experience in research management including two (2) years' of clinical trials management.

Experience managing people. 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.

Finalistis required to complete Ascension Seton Research Affiliate application; part of this involves proof of and / or completion of immunizations for our affiliates approval.

Preferred Qualifications

Experience working with REDCap, SmartSheet, Qualtrics, and other clinical trial EDCs. Experience assisting with research submissions and administration of funds.

Experience conducting research in UT Dell Medical School setting, Ascension Seton setting or higher education setting.

Salary Range

$80,000+ 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.

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.

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.

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.

Background Checks :

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