Clinical Research Coordinator- Bilingual Support - 140401

The Urogynecology and Reproductive Surgery (URPS) research group includes 5 faculty, 3 rotating clinical fellows and rotating gynecology and urology residents. The core research team is comprised of a full time Project Manager who will be responsible for supervision and implementation of all active research protocols, two Clinical Research Coordinators, one Clinical Research Coordination Assistant, and one undergraduate student assistant who will be responsible for working closely with the principle investigators and project manager in the implementation of several existing and new protocols developed over the coming years. The UCSD URPS group is a standing member of NIH sponsored research through the Pelvic Floor Disorders Network (PFDN) as well as participants in multi-center research through the Patient Centered Outcomes Research Institute (PCORI). The group also participates in industry sponsored studies and smaller clinical trials Currently the group is participating in 6 active research protocols and maintaining records and compliance documents for approximately 10 open studies. The group anticipates continued grant support from federal and industry sources with new protocols under development and review.

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.

When necessary, our unit provides research support to other principal investigators within the Obstetrics, Gynecology & Reproductive Sciences Department time and resources permitting.Incumbent will work with Project Manager and Asst. Clinical Research Coordinators to oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects. Assure compliance with institutional, state, and federal regulatory guidelines. Collect data (including non -invasive physical examination procedures e.g. vital signs, bladder scanning urine testing) and oversee the quality of the medical and clinical research data. Monitor treatment and toxicities, adverse event reports, laboratory and specimen (e.g. urine, blood, stool, vaginal swabs, etc.) collection, processing, and submission. Review lab results and lab data and help identify abnormal results. Review electronic records to identify potential study participants and follow outcomes. Assist with writing proposals, progress reports, and manuscripts. Help with development and distribution of recruitment materials. Participate and oversee community engagement, outreach and recruitment activities. Provide regulatory departments with timely research submissions, renewals, amendments, and safety reports. Communicate directly with assigned physicians and research groups within and outside of UCSD, including attending weekly and quarterly meetings. Review and verify university research account statements, professional fee statements, and invoicing. Participate in development and implementation of budgets related to clinical trials including protocol coverage analysis. Conduct qualitative interviews.

• Strong theoretical knowledge and/or Bachelor's Degree in a social science or basic science such as Biology, Microbiology or a related field and/or an equivalent combination of education and work experience.

• Demonstrated experience in clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design, evaluation, development, including coverage analysis and conduct qualitative interviews.

• Demonstrated advanced understanding of women's health research and urogynecologist conditions.

• Experience engaging with community dwelling women to recruit for clinical trials involving urogynecologic conditions.

• Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.

• Demonstrated experience with community engagement, outreach, and recruitment activities

• Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).

• Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.

• Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.

• Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.

• Strong experience completing clinical trials case report forms via hard copy and online.

• Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities to establish useful resources and University contacts.

• Ability to discern items that can be handled independently and those which require attention of supervisor, including ability to quickly determine subject matter of material and necessary action to be taken in a timely manner.

• Working knowledge of medical and scientific terminology.

• Proven ability to problem solve and resolve conflict.

• Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.

• Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills.

• Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience in conducting searches on the internet.

• Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

• Strong experience with abstraction of demographic and clinical data from electronic health records systems.

• Strong experience with designing and building clinical databases in environments such as REDCap.

• Occasional evenings and weekends may be required, rare nights may be required.

• Knowledge of cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.

• Possess a Clinical Research Coordinator Certificate, or Masters Degree.

• Bilingual in English and Spanish (speak, read, and write).

• Extensive experience with conducting focus groups studies in English and Spanish

• Master's degree in public health.

• CITI Training and GCP Certification Preferred.

• Job offer is contingent upon satisfactory clearance based on Background Check results.
• Occasional evenings and weekends may be required.
• Must have access to reliable transportation for off site visits and be willing to travel to study sites in San Diego.
• Must be willing to travel in the U.S. an average of quarterly to attend 2 to 3 days of research meetings and/or training.