Clinical Research Coordinator- Bilingual Support - 140401

About the role

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, two Clinical Research Coordinators, one Clinical Research Coordination Assistant, and one undergraduate student assistant.

Responsibilities

• Oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects.
• Affirm compliance with institutional, state, and federal regulatory guidelines.
• Collect data, oversee the quality of medical and clinical research data, monitor treatment and toxicities, adverse event reports, laboratory and specimen 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.

Requirements

• 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.

Qualifications

• 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.