Job Description

Payroll Title:
CLIN RSCH CRD SR EX
Department:
ANESTHESIOLOGY
Hiring Pay Scale
$87,334.36 - $100,784.10 /Year
Worksite:
East Campus (La Jolla)
Appointment Type:
Career
Appointment Percent:
100%
Union:
RX Contract
Total Openings:
1
Work Schedule:
Days, 8 hrs/day, Monday-Friday

#129002 Senior Clinical Research Coordinator

Filing Deadline: Mon 4/15/2024

UC San Diego values equity, diversity, and inclusion. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply.

UCSD Layoff from Career Appointment: Apply by 04/3/2024 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 04/15/2024. Eligible Special Selection clients should contact their Disability Counselor for assistance.

DESCRIPTION

The Department of Anesthesiology employs over 200 academic and staff personnel and has an annual operating budget of $40 million in annualized resources between Practice Plan Revenues, VAMC funding, Hospital and Medical Group Funding, UC Foundation, Research Sources and School of Medicine Funds. There are over 60 clinical faculty, 12 Ph.D, faculty and post docs, 36 residents, 8 clinical fellows, 27 Certified Nurse Anesthetists, 1 Physician Assistant and four bargaining units represented. The Department provides Clinical Anesthesia, Critical Care and Pain Services at Hillcrest, Thornton, Shiley, Children's and the VAMC. The Department operates a Pain Clinic at Perlman. The Department's research programs include bench and clinical research programs located at the VAMC, MTF, CTF, Hillcrest, Thornton and Sanford Consortium for Regenerative Medicine.

This position is part of the Anesthesiology Critical Care Service (ACCM). The ACCM provides critical care for all cardiac/thoracic surgery, cardiology heart failure, and thoracic and vascular surgery patients in the ICU. The faculty are anesthesiologists and all are board certified in critical care medicine. The staffing of the unit is composed of the attending, ACCM fellow, anesthesiology resident(s), as well as a number of UCSD medical students.

Drawing on experience with Industry, National Institutes of Health (NIH), and society sponsored research, the incumbent will monitor study participant compliance, evaluation and quality assurance procedures, oversee the quality of clinical and research data and write annual reports; oversee the regulatory process for site, Institutional Review Board (IRB), research compliance and Food and Drug Administration (FDA) audits, and ensure compliance of Health Insurance Portability and Accountability Act (HIPAA) regulations of patient confidentiality throughout the studies, manage the acquisition, preparation, and distribution of patient financial compensation.

The incumbent will contribute original ideas for developing, improving, and implementing study protocols, offering insight at the regulatory, operational, clinical, and technical levels. Incumbent will oversee the conduct of Clinical Trials by ensuring protocol compliance, filing adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files.

Incumbent will draft and assist in the drafting of manuscripts as an author or coauthor. Manuscript contributions will include study design, collage/figure design and creation, analysis of manuscript data, and completion and submission of manuscript. The candidate will be responsible for assigned aspects of grant proposal preparation and submission, including technical writing and editing, budget preparation, and aiding in compliance with federal, state and university regulatory requirements for funded research.

Key to this role is the preparation of study protocols, related regulatory documents, and progress reports for submission to the IRB; oversight and management of laboratory operations, such as ordering lab and study supplies, keeping up to date on safety protocols, clinical billing recharges, and IRB approval and maintenance. This includes acting as a liaison for numerous investigators and staff.

Incumbent will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, monitoring patients, and maintenance of accurate and complete clinical research files. Create informational and recruitment materials and act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies. The Clinical Research Coordinator will plan, develop and implement start-up procedures for multiple phase I-IV research studies in assigned disease team as well as lead, direct, and coordinator operational efforts. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Provide education and information to the public concerning the ongoing clinical trials. Assist PIs with proposals, progress reports and manuscripts. Independently create original documents and policies for assigned disease teams. Work closely withfederal and state regulatory officials.

MINIMUM QUALIFICATIONS

  • Four years of related experience, education/training, OR a Associate’s degree in related area.

  • Demonstrated experience in clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.

  • 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.

  • 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.

  • Strong knowledge of investigational protocols management, query resolution, protocol design, protocol writing and protocol implementation).

  • 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 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 inconducting searches on the internet.

  • Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

  • Strong theoretical knowledge and 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.

  • Clinical Trial Professional certification from a professional society within one year in position.

PREFERRED QUALIFICATIONS

  • At least 2 years of demonstrated experience working with patients either in a clinical or research setting.

SPECIAL CONDITIONS

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

  • Pre-employment physical and TB test required.

Pay Transparency Act

Annual Full Pay Range: $81,334 - $130,784 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $38.95 - $62.64

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.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community.

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.

Application Instructions

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