Clinical Research Project Manager, Department of Women's Health, Dell Medical School

Clinical Research Project Manager

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

• 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

Regulatory Management

Required Qualifications

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.

Preferred Qualifications

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.

Salary Range

OPEN

Working Conditions

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.

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. This position has the option to elect the Optional Retirement Program (ORP) instead of TRS, subject to the position