Project Manager, OB/GYN Reproductive Sciences - 139871

This position will work a hybrid schedule which includes a combination of working both onsite in La Jolla and remote.

The UCSD Department of Obstetrics, Gynecology and Reproductive Sciences is composed of Clinical and Research Faculty, Clinical Fellows, Residents, Project Scientists, and Postdoctoral Scholars. The department is composed of 8 divisions: Obstetrics and Gynecology, Maternal-Fetal Medicine, Gynecologic Oncology, Reproductive Endocrinology and Infertility, Hospitalist, Complex Family Planning, Urogynecologic and Reconstructive Surgery, and Minimally Invasive Gynecologic Surgery.

The Urogynecology and Reconstructive Pelvic Surgery research group includes 7 faculty, 3 rotating clinical fellows, and rotating gynecology and urology residents. The core research team is comprised of a full-time Program Manager (current posting), Clinical Research Coordinators and Clinical Research Coordinator Assistant. The Program Manager will be responsible for working closely with the Principal Investigator and team in the oversight of several new and ongoing protocols. The UCSD URPS Research group is a standing member of the Pelvic Floor Disorders Network (PFDN), an NIH funded research consortium, as well as the Patient Centered Outcomes Research Institute (PCORI). The group also participates in industry sponsored studies and smaller investigator initiated clinical trials. The research team also supports fellows and residents in their projects as needed and directed by the division director (Dr. Lukacz).

The Pelvic Floor Disorders Network (PFDN) is a national research collaboration between seven universities and medical institutions. The PFDN conducts a variety of clinical trials (medical, surgical, and therapeutic) focused on treatment of women with pelvic floor disorders such as urinary incontinence and pelvic organ prolapse. The UCSD URPS site is one of two San Diego based clinical trial sites, along with Kaiser Permanente San Diego. UCSD URPS Research is currently conducting longitudinal follow-up protocol activities on 40 active patients. Primary research activities center around randomized trials that conduct observational evaluations on women that undergo pelvic organ prolapse surgical repair, a randomized trial of Bulking Injection vs. Single-incision-sling surgery for stress urinary incontinence, and a randomized trial comparing efficacy of education in the treatment of bothersome incontinence postpartum.

The Patient Centered Outcomes Research Institute (PCORI) is a non-profit research organization focused on patient-centered comparative clinical effectiveness research. URPS research under PCORI is currently focused on randomized trials to fill the evidence gap with direct-comparison data on patient-important efficacy and safety outcomes between a beta-agonist medication versus Botox A in the treatment of UUI, and comparing urethral bulking with polyacrylamide gel versus mid-urethral sling to address stress urinary incontinence repair at the time of pelvic organ prolapse repair. When necessary, our group provides research support to other principal investigators and fellows within the OBGYN & Reproductive Sciences Department and Urology URPS divisions, time and resources permitting.

Working with the PI, the Project Manager will provide overall project oversight for the Women's Pelvic Medicine program and apply extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity within national sectors. This role is primarily responsible for the development, implementation, and management of multiple clinical trial programs and will closely oversee the work of the research team, including clinical research coordinators and clinical research coordinator assistants in implementation and conduct of the various research activities within the division of Urogynecology and Reconstructive Pelvic Surgery and Department of OB/GYN and Reproductive Sciences.

Work directly with PIs to identify issues, find resolutions, and create an analyze reports. Trains individuals and departments on relevant compliance processes and policies including students and junior research coordinators and assistants in the enrollment, data abstraction, data collection, and regulatory submissions for the unit. Research compliance concepts, policies, and procedures, and protocols. Development of operating procedures and guidelines. Oversee the process of human subjects and research activities.

Uses skills as seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies/procedures to apply federal, state, and university regulations, policies, and guidelines, and promote best practices. Interacts frequently with investigators across multiple institutions and persons in other organizational departments. Interactions require the use of fact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Errors or omissions may ultimately place research participants at undo risk and/or compromise the institution's assurance of regulatory compliance with the federal government.

Applies extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity.

• Nine(9) years of relevant experience or a Bachelor's degree plus five (5) years of related experience/training.

• Advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology. Advanced knowledge of regulatory requirements. Preferably in Urogynecology and Reconstructive Pelvic Surgery

• Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.

• Advanced knowledge of computer software with sophisticated retrieval, storage, and merging capabilities. In depth experience with medical records (Epic) for reviewing hospitalizations, laboratory results, and other clinical data.

• Advanced knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents.

• In depth experience overseeing/managing clinical trials in a diseased population with multiple health problems in Women's Pelvic Medicine, Urogynecology and Reconstructive Pelvic Surgery. Ability to read scientific text for general understanding of basic concepts. Ability to summarize and convey technical and medical information to lay individuals at a level appropriate for their understanding.

• Advanced communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to effectively collaborate with University, Health Staff, Faculty, Researchers, Clinical teams, and investigators across multiple institutions.

• In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems.

• Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals.

• Proven ability to perform all commonly applicable functions in word processing and spreadsheet software. Advanced knowledge of clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.

• In depth ability to work collaboratively with other cross-functional teams. In depth ability to interface, collaborate and influence / persuade other members of an extended study team.

• Experience is Urogynecology and Reconstructive Pelvic Surgery.

• Flexible schedule may be required to meet meeting attendance and project requirements.
• Must be willing to travel in the U.S. an average of quarterly to attend meetings and/or training.
• Must have access to reliable transportation for off-site visits and be willing to travel to study sites in San Diego.
• Job offer is contingent upon satisfactory clearance based on Background Check results.