111818 - Bilingual Clinical Research Coordinator
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#111818 Bilingual Clinical Research CoordinatorInitial Review Date: Mon 10/11/2021
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The UCSD Department of Obstetrics, Gynecology and Reproductive Sciences is composed of 7 divisions, including Female Pelvic Medicine and Reconstructive Surgery (FPMRS).
The Women’s Pelvic Medicine Center (WPMC) 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 Research Compliance Analyst, Clinical Research Coordinator (current posting) and students engaged in data entry and administrative support. The Clinical Research Coordinator will be responsible for working closely with the Principal Investigator and team in the implementation of several new and ongoing protocols. The UCSD Women’s Pelvic Medicine Research group is a standing member of several NIH sponsored research consortiums, including the Pelvic Floor Disorders Network (PFDN) and the Prevention of Lower Urinary Tract Symptoms (PLUS). 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 program director (Dr. Lukacz)1. The Prevention of Lower Urinary Symptoms (PLUS) network is a trans-disciplinary group of investigators developing a research agenda for the prevention of lower urinary symptoms (LUTS) across the nation. The PLUS consortium is currently focused on instrument validation and qualitative research in bladder health and prevention of LUTS. Protocol development is underway for a large-scale, multi-centered, longitudinal cohort with in-person assessments, specimen collections, and survey follow-up over a 5+ year period. UCSD WPMC Research is tasked with recruiting and enrolling bilingual Spanish/English speaking participants for our studies.
2. 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 fecal/urinary incontinence and pelvic organ prolapse. The UCSD WPMC site is one of three San Diego based clinical trial sites, along with Kaiser Permanente San Diego and Downey. UCSD WPMC 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 and a randomized trial of Botox vs. Sling surgery for mixed urinary incontinence. Additional PFDN protocols in start-up phase will focus on surgical specimen collection, processing, and shipment to a centralized biomed laboratory.
When necessary, our group provides research support to other principal investigators and fellows within the OBGYN & Reproductive Sciences Department and Urology FPMRS divisions, time and resources permitting.
Reports directly to the PI of Women's Pelvic Medicine Research. Incumbent will work with Research Compliance Analyst and Ast. Clinical Research Coordinator to coordinate and 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, muscle strength 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. Assist with writing proposals, progress reports, and manuscripts. Help with development and distribution of recruitment materials. Participate in 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. Assist with development and implementation of budgets related to clinical trials, including protocol coverage analysis. Conduct qualitative interviews in English and Spanish and translate related materials as needed.
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 and evaluation.
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.
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.
Bilingual in English and Spanish (speak, read, and write).
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.
Employment is subject to a criminal background check and pre-employment physical.
Flexible schedule may be required to meet meeting attendance and project requirements.
Must have access to reliable transportation.
Must be willing to travel in the U.S. an average of quarterly to attend 2 to 3 days of meetings and/or training
Occasional evenings and weekends may be required, rare nights may be required.
Must be able to speak, read, write in Spanish.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
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