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.

• 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.

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

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

• Pre-employment physical and TB test required.