Clinical Research Applications Analyst - 117796
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#117796 Clinical Research Applications AnalystExtended Deadline: Mon 8/22/2022
For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus and influenza before they will be allowed on campus or in a facility or office. For more information visit: Flu Vaccine Mandate / COVID Vaccine Policy
This position will remain open until a successful candidate has been identified.
This position has recently been accreted by Teamsters CX union, and will be a part of that union moving forward.
UCSD Layoff from Career Appointment: Apply by 08/02/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 08/11/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.
This position will work a hybrid schedule which includes a combination of working both onsite at ACTRI in La Jolla and remote.
The ACTRI provides investigators with Clinical Research Management Systems to support clinical research studies including clinical trials, biospecimen repositories, and observational studies. These software systems provide for secure capture and management of clinical study data, management of study/visit schedules, and management of budgets and associated financial data.
Incumbent will serve as a Clinical Research Applications Support Analyst, supporting applications and databases including Epic RM and Velos eResearch, comprehensive enterprise-wide EHR/CTMS database integrated programs offered by the ACTRI, that tracks clinical trial activities from start-up to close-out of the trial. Incumbents responsibilities will include but are not limited to: receive, track and assign all coverage analyses received from the Office of Coverage Analysis Administration to team members for completion in Epic and Velos, assist user with questions and provide guidance relating to the Clinical Research Billing Process, provide training and assist with designing workflows to improve the overall process. Incumbent will also assist in supporting Epic Research Module, and REDCAP databases for observational clinical studies.
Duties include coordinating with clinical trials/clinical research staff; reviewing consent and study protocols to determine study requirements; building the study protocols into EHR and CTMS, REDCap, Epic research module protocols; establishing study calendars and milestones for actions; and assisting with training users. Schedule meetings with investigators and staff, follow-up with users and serve as point of contact for issue resolution. Track and report on: regulatory reviews, subject enrollment, budgeting and invoicing for trials. Work directly with the Epic, Velos and REDCap Managers and ACTRI IT operations team to assure the integrity of collected data and satisfaction of users.
Six (6) years of related experience, education/training, OR a Bachelor’s degree in related area plus two (2) years of related experience/training.
Experience with REDCap, Encore, or Velos eResearch Clinical Trials Management Systems (CTMS) or other research database management for electronic data capture and case report forms (CRFs).
Clinical research coordination or administration experience, and familiarity with working concepts within academic medical center or life sciences industry.
Experience with Epic research or other related electronic health records system and processes for integrated research patient and revenue cycle management. Familiarity with research protocol builds for treatment and billing coverage analysis compliance.
Cloud based applications and systems support (AWS, Azure, Google) in a secure HIPAA compliant infrastructure, for compliance and regulatory services.
Knowledge of data management systems, practices and standards. Working experience with clinical research processes and integration with use of health records and other database management systems.
Effective communication and interpersonal skills. Ability to communicate technical information to technical and non-technical personnel at various levels in the organization. Experience coordinating and/or leading training activities with both staff and faculty.
Theoretical knowledge of a biological science or related field and experience working on studies related to clinical research.
Experience supporting data analytics, reporting and/or relational database systems concepts (Tableau, Excel, Crystal reports, SQL, Python).
Strong analytical and design skills, including the ability to abstract information requirements from real-world processes to understand information flows in computer systems.
Ability to prepare simple data models under guidance of more senior professionals.
Familiarity with important types of data models such as logical / relational models, dimensional models and document models.
Intermediate knowledge of relevant rules and regulations.
Demonstrated service orientation skills.
Ability to represent relevant information in abstract models. Critical thinking skills and attention to detail.
Knowledge relating to logical data design, data warehouse design, data integration or the management of web content or other unstructured data.
- Knowledge of clinical research including the conduct of commercial, federal and PI initiated protocols. Strong demonstrated experience working with clinical and clinical trials research activities, regulatory compliance, guidelines related to IRB informed consent, as well as interpreting and comprehending complex clinical research protocols, activities and guidelines.
- Knowledge of standard healthcare terminologies such as ICD-9, SNOMED-CT. Knowledge of healthcare information models such as CDISC, HL7 RIM.
- Working knowledge of Information Systems pertinent to the subject matter including EPIC, IDX, Velos. Experience with software and organizational systems for storage and tracking human subjects information over multiple studies.
- Employment is subject to a criminal background check.
- Overtime may be required.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.
UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!
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