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 Bilingual Assistant Clinical Research Coordinator - San Diego, California, United States

   
Job information
Posted by: UC San Diego 
Hiring entity type: Other 
Work authorization: Existing work authorization required for United States
Position type: Direct Hire, Full-Time 
Compensation: ******
Benefits: See below
Relocation: Not specified 
Position functions: Health - Research
 
Travel: Unspecified 
Accept candidates: from anywhere 
Languages: Spanish - Fluent
 
Minimum education: See below 
Minimum years experience: See below 
Resumes accepted in: English
Cover letter: No cover letter requested
Job code: 725453264 / Latpro-3754264 
Date posted: Sep-13-2020
State, Zip: California, 92101

Description


UCSD Layoff from Career Appointment : Apply by 9/16/20 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants : Apply by 9/25/20. Eligible Special Selection clients should contact their Disability Counselor for assistance.

DESCRIPTION

The UCSD Women's Pelvic Medicine Research group is a standing member of several NIH sponsored research consortiums including PFDN; Pelvic Floor Disorders network and PLUS; Prevention of Lower Urinary Tract Symptoms. 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.

  1. The Pelvic Floor Disorders Network (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 PFDN is a national research collaboration between seven universities and medical institutions around the nation. UCSD WPMC-R is currently conducting longitudinal follow up research protocol activities on approximately 40 active patients. The UCSD site is one of three San Diego based clinical trial sites along with Kaiser Permanente San Diego and Downey. Coordination and communication with investigators and research personnel at these site has been established for nearly 20 years.
  2. The main follow up 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.
  3. Additional PFDN protocols in startup phase will focus on surgical specimen collection, processing and shipment to a centralized biomed laboratory.
  4. 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 the area of 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. The UCSD site is tasked with recruiting and enrolling bilingual Spanish/English speaking participants for our studies.
  5. Recurrent Urinary Tract Infection and linking the host genome to the urinary microbiota clinical research study. This research study aims to find out more about recurrent urinary tract infection how it relates to the urinary microbiome and how to collect urine in order to better study its relationship.
  6. Other industry sponsored clinical trials that are closing soon include observational longitudinal studies of women undergoing prolapse and incontinence surgeries.

When necessary, our unit provides research support to other principal investigators within the Obstetrics, Gynecology & Reproductive Sciences Department time and resources permitting.

Reports directly to the PI of Women's Pelvic Medicine Research. Assist with coordination and management of clinical trials including supporting all aspects of protocol research protocol development/management, including screening for patient eligibility, data collection (including non invasive physical examination procedures e.g. vital signs, bladder scanning) and analysis, ensuring protocol compliance, adverse event reports, monitoring treatment and toxicities, laboratory and specimen (e.g. urine, blood, stool, vaginal swabs, etc) collection, processing and submission, and maintenance of accurate and complete clinical research records. Assist PI and Research Compliance Analyst with pre-screening patients for eligibility, maintaining screening and enrollment tables, review of lab result and lab data and help identify abnormal results. Assist with writing proposals, progress reports and manuscripts. Help development and distribution of recruitment materials. Assist the regulatory department with Human subject research submissions, renewals, and safety reports. Directly communicate with assigned physicians and research groups within and outside UCSD, including attending weekly meetings as Ast. Clinical Research Coordinator member within the PFDN and PLUS networks and local meetings with PIs. Provide direct assistance to the Research Compliance Analyst in reviewing and verifying university research account statements, professional fee statements, and invoicing.

The Ast. Clinical Research Coordinator will assist with development and implementation of budgets related to clinical trials. Assist the investigators with start up regulations and research protocol. Translate from English to Spanish, study documents including recruitment materials, questionnaires, and consent form. Conduct and translate Spanish to English qualitative interviews. Assist with IRB applications/renewals, review abstracts, journal manuscripts and study correspondence.

The Ast. Clinical Research Coordinator will be responsible for assisting the Research Compliance Analyst in the implementation of PLUS protocols ongoing and in the future. Will develop skills to understand industry practices.

MINIMUM QUALIFICATIONS
  • Theoretical knowledge of biology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's degree, or an equivalent combination of education and experience.

  • Bilingual English/Spanish (Written and Verbal).

  • CITI Certified.

  • Experience performing clinical research duties in a clinical research environment.

  • Experience with clinical trials participant or study subject recruitment.

  • Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word.

  • Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.

  • Experience working with FDA policies regulating clinical trials.

  • Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.

  • Experience interpreting medical charts and abstracting data from medical records.

  • Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.

  • Experience maintaining files and keeping records.

  • Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a diverse population. Excellent phone etiquette skills.

PREFERRED QUALIFICATIONS
  • Certification as a Clinical Research Associate or Coordinator.

  • Experience working with research bulk accounts.

  • Experience with investigational drug authorization criteria.

  • Experience coordinating study startup activities.

  • Experience providing in-service training to various research personnel on protocols, processes, and procedures.

  • Knowledge of x-rays, scans, and other diagnostic procedures.

SPECIAL CONDITIONS
  • Employment is subject to a criminal background check and pre-employment physical.

  • 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.



Requirements

See job description.

 

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