Assistant Clinical Research Coordinator - 141770

In conjunction with and under supervision of the manager, incumbent will coordinate and assist with start-up procedures, recruitment, screening, enrollment, and maintenance of subjects. The Assistant Clinical Research Coordinator will assist operations, ensure compliance with state and federal regulatory guidelines, assist with maintaining the medical and clinical research data, and directly communicate with assigned physicians. They will serve as a resource to the investigators to interpret, educate and inform concerning the ongoing clinical trials, assist PIs with proposals, progress reports and manuscripts, assist with creating original documents and policies for assigned disease teams, work closely with federal and state regulatory officials when/if indicated. Perform laboratory and data collection activities; processing and submitting laboratory specimens; collecting and entering research data; maintaining accurate and complete clinical research files and patient medical charts.

Other duties assigned as assigned.

• Theoretical knowledge of biology, microbiology, social sciences, clinical sciences and/or Bachelor's degree, and/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 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.

• 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 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.

• 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.

• Must be able to work various hours and locations based on business needs.
• Employment is subject to a criminal background check.
• Employment is subject to pre-employment physical for those who work in clinical settings and/or with patients.
• Performs other duties as assigned.
• Complies with all policies and standards.
• Complies with the University of California, San Diego Health (UCSDH) Principles of Community.
• This position description is not intended to be a complete list of all responsibilities, duties or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.