Clinical Research and Regulatory Coordinator - 129118

UCSD Layoff from Career Appointment: Apply by 04/10/2024 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 04/22/2024. Eligible Special Selection clients should contact their Disability Counselor for assistance.

Under general supervision of the Principal Investigator and Project Manager, incumbent will assist in study initiation and provide regulatory services including administrative support that includes submission of initial clinical research applications, amendments and renewals to the Institutional Review Boards as well as maintenance of regulatory documentation, working with study monitors as well as working with related, collaborating University offices such as Radiation Safety, Biosafety, Conflict of Interest Office (COI), Office of Coverage Analysis (OCAA) and Office of Clinical Trials Administration (OCTA) and external regulatory offices such as independent IRBs. The incumbent is responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files Incumbent should have knowledge of HHS-OHRP, FDA, HIPAA regulations as well as Good Clinical Practices (GCP). Knowledgeable about clinical trials administration and regulatory monitoring. Other duties as assigned.

• 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.

• Experience performing clinical research duties in a clinical research environment. Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.

• Experience creating Informed Consent Documents that comply with HRPP/UCSD IRB policies and procedures, FDA regulations, and sponsor requirements.

• Experience preparing various forms, documents, and reports, such as Investigational Drug Fact Sheet, New Study Applications, Renewal Applications, IND Applications, etc. Experience preparing, reviewing, and understanding clinical research protocols and protocol amendments.

• Experience using standard word processing and data management software programs, including Word and Excel, in order to develop and prepare reports.

• Experience developing and maintaining record management systems. Strong administrative and organization skills, experience prioritizing assignments when faced with a heavy workload and competing deadlines.

• Excellent interpersonal, as well as written and oral 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.

• Experience coordinating study startup activities.

• Experience with editing, including summarizing information into concise and condense documents.

• Skill in working independently and following through on assignments with minimal supervision. Good judgement to know when to ask for assistance from supervisor in cases where regulations and policies & procedures are not clear.

• Proven ability to determine sources of information and data, and to analyze the data and information obtained, in order to create documents and to propose solutions to issues. Detail oriented, logical, and methodological approach to problem solving.

• Demonstrated ability to exercise judgment, tact, and firmness in interaction with faculty, students, staff and IRB members, subjects and others.

• Demonstrated knowledge or demonstrated related experiences to comprehend, interpret, and apply regulations and legislation regarding the protection of human subjects. These include regulations under federal policies, FDA, and other compliance agencies or directive.

• Working knowledge of UCSD Human Research Protections Program (HRPP/IRB) policies and Procedures.

• Experience interpreting medical charts, experience in abstracting data from medical records in relation to study subject screening.

• Experience in medical assessment, patient interviewing, and interpreting laboratory procedures and values to determine toxicities and patient eligibility related to protocol management.

• Experience working with research bulk accounts.

• Experience with investigational drug authorization criteria.

• Demonstrated knowledge of Irritable Bowel Disease research and implications.

• Demonstrated knowledge of Gastroenterology medical terminology.

• Experience working with The United States Food and Drug Administration (FDA) policies regulating clinical trials.

• 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.

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

• Must be able to maintain strict confidentiality.

• Occasional evenings and weekends may be required.

Pay Transparency Act

Annual Full Pay Range: $64,812 - $104,275 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $31.04 - $49.94

Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).

If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.

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!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

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UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.