Senior Research Project Manager, Women's Health

Job Posting Title:

Senior Research Project Manager, Women's Health

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Hiring Department:

Department of Women's Health

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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:

Immediately

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Position Duration:

Expected to Continue

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Location:

AUSTIN, TX

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Job Details:

PURPOSE

The Senior 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 Director of Research. A particular focus of this position is working closely with leadership to oversee the execution and smooth operations of research projects, ensuring projects meet research objectives within their specified timeframes.

RESPONSIBILITIES

Research Project Management

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

• Support day-to-day project management and coordination for multiple studies, which may vary in scope and clinical area. 

• Support 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.  

• 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. 

Team Support & Development

• Recruit and manage research volunteers and students across all research projects (research assistants/ research coordinators).

• Oversee the administrative aspects of professional development and training of research staff.

• 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 sta