Clinical Research Analyst - 114230
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#114230 Clinical Research AnalystExtended Review Date: Wed 5/11/2022
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
UCSD Layoff from Career Appointment: Apply by 02/04/22 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 02/16/22. Eligible Special Selection clients should contact their Disability Counselor for assistance.
This position will remain open until a successful candidate has been identified.
The Department of Orthopaedic Surgery is a vibrant and growing Orthopaedic Surgery Department of 48 full-time faculty and 50 voluntary faculty, 4 physicians on MSP contracts, 32 trainees, and 34 staff that supports and participates in the academic, clinical, and research mission of UC San Diego. The Department generates over $12M in clinical revenue, and $5M (NIH & other) in research grants and contracts, with total annual expenditures exceeding $30M. The Department is a comprehensive orthopaedic group located in San Diego that offers a full spectrum of musculoskeletal clinical care, specializing in foot and ankle, hand, joint reconstruction, physical medicine and rehabilitation, spine, sports, and trauma. Research expertise includes advancements in muscle metabolism and physiology, neuromuscular bioengineering, intervertebral disc, and musculoskeletal physiology and epidemiology.
The Clinical Research Analyst will be independently responsible for the development, execution and overall management of multiple study protocols for Orthopaedic Surgery. Responsibilities will include contributing to the planning and development of research designs and methods; making important original contributions to intervention development and implementation; providing input and contributing original ideas of major methodological significance on research direction and data interpretation; providing leadership and direction to those conducting research within the Department; reading and understanding scientific articles pertaining to related research and the use of technology in clinical trials and outcomes; directing the collection of clinical data and contributing to preparation of data for publication, presentations, and reporting.
This includes coordinating with both internal and external organizations as needed for the oversight of ongoing research studies. Incumbent is responsible for protocol development, writing proposals, progress reports and manuscripts, creating informational and recruitment materials, assisting with the project budget and overseeing day to day patient activities, as well as acting as a liaison with other UCSD departments and community clinics / agencies for the purpose of implementation of studies.
Ensure the proper execution of administrative and regulatory activities including IRB requirements, grant progress reports, and University policies and procedures. Assure compliance with state and federal regulatory guidelines. Oversees the quality of the clinical research data, including databases and datasets. This position develops and maintains Standard Operating Procedures for ongoing research studies. Supervises research staff in the execution of the research protocols and research activities.
Nine (9) years of related experience, education/training, OR a Bachelor’s degree in related area plus five (5) years of related experience/training.
Advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology. Advanced knowledge of regulatory requirements.
Demonstrated experience in research protocol activation, marketing, outreach, recruitment and maintaining a research study cohort.
Experience interpreting clinical findings to assure compliance with the protocol and prompt reporting of adverse events and protocol deviations.
Extensive experience and expertise in conducting clinical trials and the ability to train staff regarding Food and Drug Agency regulations and Good Clinical Practices. Understanding of research activities and guidelines related to consent, ethical conduct and protection of human subjects. Ability to maintain patient confidentiality.
In-depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems. Ability to read, understand, and learn study procedures from protocols
Strong communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to communicate with participants, staff and physicians with professionalism, sensitivity and discretion. Skilled at negotiating with various personalities and developing internal and external network of contacts.
Effective interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals.
Proven ability to perform all commonly applicable functions in word processing and spreadsheet software. Advanced knowledge of clinical information and documentation application programs. Proven ability utilizing clinical trial management systems. Experience using clinical trials management software such as REDCap, Basecamp, and VELOS.
Advanced theoretical knowledge of basic science such as Biology, Microbiology or a related field. Advanced theoretical background of research methods, protocol design, and implementation. Strong theoretical knowledge of scientific disciplines in addition to extensive experience in Orthopaedic Surgery clinical trials.
Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Thorough Database Management skills, with computer software and internet proficiency.
Experience performing anthropometrics, vital signs and using clinical laboratory equipment including pipettes, and centrifuges. Experience with blood processing and IATA certification to ship biological samples.
Advanced skills in data analysis, presentation and publication. Extensive experience collecting, evaluating, and summarizing scientific data.
Demonstrated ability to take patient history, evaluate patient problems and provide complete documentation in patient record.
- Bilingual, English/Spanish speaking.
- Knowledge of and experience with cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.
- Employment is subject to a criminal background check and pre-employment physical.
- Occasional evenings and weekends 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).
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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