Senior Research Project Manager, Women's Health

The University of Texas at Austin•Austin, TX

14d

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

Research Project Management W ork 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 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 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.
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.
Outreach & Recruitment Support coordination of research recruitment and outreach events, including logistics, purchasing, and reimbursements.
Submit and track OOEFs for research events and activities.
Administrative & Operational Support Oversee purchasing and payments related to research projects (including Tango cards, Procard reconciliation, reimbursements, vendor coordination).
Track research-related expenditures using SmartSheet and Box; maintain organized financial and administrative logs.
Maintain departmental training logs and ensure faculty, staff, fellows, residents, and volunteers are current with required research trainings (CITI, UT compliance, etc.).
Develop and maintain Standard Operating Procedures (SOPs) for study-level processes.