Clinical Research Coordinator, Neurosciences - 141237

The Alzheimer's Disease Cooperative Study (ADCS) is a progressive, multi-site clinical research consortium created to provide an operational framework for Alzheimer's disease clinical trials and research projects. It was formed in 1991 as a cooperative agreement between the National Institute on Aging (NIA) and the University of California, San Diego and has since served as a cornerstone of Alzheimer's disease clinical research across the country. The ADCS promotes the discovery, development, and testing of new drugs, natural products, and lifestyle interventions for the treatment or prevention of Alzheimer's disease, particularly those that are novel or in a proof-of-concept stage. The ADCS infrastructure includes expertise in study design and conduct, and full clinical trial management capabilities through our coordinating center and network of 50+ research sites that participate in studies coordinated by the ADCS. The ADCS provides expertise in developing Alzheimer's disease protocols, recruitment, and management of multiple clinical trials or prospective cohort studies of varying sizes and complexity as a coordinating center as well as a site. The ADCS has a robust program in large data projects and informatics involving secondary data analysis, harmonization, and emulated trials using electronic health records (EHR). The mission of the ADCS research program is accomplished with a diversified funding portfolio, ranging from federal funding such as NIH, to Industry Partners, Foundations, and Gifts.

The Clinical Research Coordinator coordinates and oversees study start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of clinical research participants, in addition to other activities as needed to support clinical research at the ADCS. Possesses detailed knowledge of protocols to create informational and recruitment materials. Acts as a liaison with other UCSD departments, external partners, and agencies for the purpose of implementation of clinical research. The Clinical Research Coordinator plans, develops and implements start-up procedures for multiple research trials and programs as well as leads, directs, and coordinates clinical operations efforts. Ensures compliance with state and federal regulatory guidelines and works with multiple sites across the ADCS network to ensure adherence to protocols, enrollment of trial participants, and adherence to timelines. Works collaboratively with external stakeholders (e.g., sponsors, vendors, rater trainers, site PIs, project directors, site coordinators), and internal stakeholders to ensure the quality of clinical research data. Provides direction and guidance to investigators. Collaborates with other team members. Provides information to the general public concerning ongoing clinical trials and studies. Assists PIs with proposals, progress reports, and manuscripts. Independently creates original documents and policies for assigned clinical trials. Ensures Good Clinical Practices (GCP) and FDA regulations are followed.

• Strong theoretical knowledge and/or 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.

• 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 (data management, query resolution, protocol design, protocol writing and protocol implementation).

• Demonstrated experience with research protocol in order to screen participants 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 in conducting searches on the internet.

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

• Proven effective interpersonal, oral, and written communication skills in Vietnamese.

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

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

• Position requires occasional travel. Must have access to reliable means of transportation.
• Must be willing to work outside of standard business hours to ensure clinical research timelines are met, especially as our sites are national.
• Must be able to work various hours and locations based on business needs.
• Employment is subject to a criminal background check.