Clinical Research Coordinator - 134143

The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel.

Under general direction of the Principal Investigator (PI) and Sponsored Project Administrator in the Pulmonary, Critical Care & Sleep Medicine Division, the Clinical Research Coordinator will independently perform and oversee the clinical research efforts for a variety of research projects and clinical trials focusing primarily on pulmonary hypertension and related conditions.

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, and maintenance of subjects. 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-III 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 general 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 with federal and state regulatory officials.

The incumbent will provide leadership to develop, execute, and manage clinical trials and contractual service agreements for the division of Pulmonary, Critical Care, and Sleep medicine. The incumbent will oversee and provide instruction to principal investigators, division research associates, and students on clinical trials and research policies and procedures, and will serve as division expert on managing complex, multi-faceted research projects. The incumbent will provide assistance and direction with planning, contribute original ideas for budget development, organization, and conduct of investigators for clinical trials and proposed clinical/contractual agreements.

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

• Demonstrated experience working in a Pulmonary & Critical Care Office or clinical research environment including knowledge of pulmonary medical terminology.

• Demonstrated experience working with patients with pulmonary hypertension or similar respiratory diseases either in a clinical or research setting. Knowledge of diagnostic studies used and medications used to treat pulmonary hypertension.

• 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 especially with pediatric oncology protocols (data 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 ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.

• 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 conducting searches on the internet.

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

• Demonstrated knowledge of contract and grant procedures and regulations.

• Knowledge of cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.

• Possess a Clinical Research Coordinator Certificate, or Master's Degree.

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

• Occasional evenings and weekends may be required.

• Must be willing to travel to occasional meetings and work weekends and evenings as needed.

• Must be willing to work with human blood and biohazardous materials.

• Must have access to reliable transportation.