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Clinical Research Coordinator

Company name
The University of California, San Francisco (UCSF)

Location
Omaha, NE

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Job Summary JOB OVERVIEW The central Wisdom Study Clinical Research Coordinator (CRC) is based at the Program Management Office (PMO). He\/she will report directly to the central Project Manager, and will work closely with the Communications and Recruitment Manager, site study coordinators, and site project managers. The CRC is primarily responsible for managing the day to day aspects of the Wisdom Study across all study sites \u2013 including supporting the site PI to run the trial, managing communications with participants that are on study or being proposed for participating, acting as the protocol expert for the site-wide team, managing accrual and data collection requirements, adhering the regulatory and safety requirements, and working with the research assistants supporting the trial. A primary focus of the position will be providing direct support to Wisdom Study participants via phone and email. The CRC will answer participant study-related questions, triage clinical questions to Breast Health Specialists, and provide overall support and coordination to the central and site study staff members. Additional responsibilities will include overseeing IRB approval for the study, maintaining site-wide IRB approval records for the duration of the trial and coordinating all Stakeholder and External Advisory Board meetings throughout the duration of the trial. Note: This is a full time career position with an approximate end date of mid-2019, with potential extension with additional trial funding. ATHENA BREAST HEALTH NETWORK \/ SURGERY The Athena Breast Health Network is a unique collaboration among the five University of California medical centers (UCSF, UCSD, UC Davis, UC Irvine, and UCLA), their affiliates, and many other public and private partners. Through Athena, over 150,000 women who are being screened for breast cancer will be followed for decades. Patients in this network receive personalized care and risk assessments, and researchers are able to create a repository of clinical and biological data and specimens. The Athena Project Management Office (PMO), which oversees these collaborations, is located at UCSF. The Athena Network has recently received funding to conduct a large scale pragmatic trial across the Athena sites. The five-year Wisdom Study will recruit 100,000 women, and the goal of the study is to test two approaches to breast cancer screening (annual screening vs. personalized breast screening) to determine which approach is most effective, safe, and preferred by women. This highly visible and impactful study requires a dedicated and motived coordinator to support the site-wide efforts to implement and execute the patient-centered outreach, consent, and surveys across all sites. ABOUT UCSF The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. Required Qualifications \u2022 High school diploma\/GED and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities \u2022 Excellent interpersonal, oral and written communication skills and the ability to interface with all levels of staff and leadership \u2022 Ability to multi-task in a fast-paced environment while working with a diverse subject population \u2022 Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines Note: Fingerprinting and background check required. Preferred Qualifications \u2022 BA\/BS degree with a major in a related field (biology, public health, psychology) and experience a research environment \u2022 In-depth understanding of clinical trials research \u2022 Fluency in the usage of IRB online iRis system for submission, renewal, and modification of protocols through this system. Experience with UC-wide Reliance Registry a plus \u2022 Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation. Knowledge on how to collect trial data while protecting human subject safety in accordance with HIPAA and PHI policy \u2022 Experience with electronic data capture systems, including electronic medical records systems \u2022 Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.) \u2022 Knowledge of medical terminology, research policies and guidelines, guidelines for packing\/shipping infectious substances, database building\/analysis, and data management within some of the following: Access, Stata, SASS\/ SPSS, and Teleform programming platforms \u2022 Experience working with all regulatory aspects of clinical trials (including FDA, NCI, local IRB, and sponsor) \u2022 Experience applying the following regulations and guidelines: o Good Clinical Practice Guidelines o Health Information and Accountability Act (HIPAA) o The Protection of Human Research Subjects o CHR regulations for recruitment and consent of research subjects Location 3450 California St. License\/Certification n\/a Job Code and Payroll Title 9335 Clinical Research Coordinator Organization Campus Work Days Monday - Friday, 8:30 am - 5:30 pm Shift Days Shift Length 8 Hours Percentage 100% Equal Employment Opportunity The University of California San Francisco is an Equal Opportunity\/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Company info

The University of California, San Francisco (UCSF)
Website : http://www.ucsf.edu

Company Profile
UC San Francisco is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and high-quality patient care. It is the only UC campus in the 10-campus system dedicated exclusively to the health sciences.

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