Clinical Research Coordinator - 137705

The Department of Neurosciences at UC San Diego and Rady Children's Hospital is seeking a motivated and experienced Clinical Research Coordinator to assist in, although not limited to, clinical trials in neurological medicine which includes mitochondrial diseases.

Incumbent will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of study participants for multiple phase I-III clinical trials. They will assure compliance with state and federal regulatory guidelines, as well as oversee the quality of the medical and clinical research data. They will provide direction and guidance to investigators and necessary information to the patient population concerning the ongoing clinical trials. They will assist the investigators with proposals, progress reports and manuscripts. The Clinical Research Coordinator is expected to work both collaboratively and independently to facilitate successful operations.

• Strong theoretical knowledge and/or Bachelor's Degree in a social science or basic science such as Biology, Biochemistry 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 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 and multi-tasking experience.

• 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.

• Certification as a Clinical Research Associate or Coordinator.

• Experience working with research bulk accounts.

• Experience with investigational drug authorization criteria.

• Knowledge of cost accounting as applied to both University and Medical Center functions.

• Possess a Clinical Research Coordinator Certificate, or Masters Degree.

• Employment is subject to a criminal background check.
• Must be willing to be vaccinated against common diseases encountered in health care.
• Must be able to obtain annual TB/fit test clearance.
• Must be able to work various hours and locations based on business needs. Occasional evenings and weekends may be required.
• Must be willing to travel to different locations (Rady Children's Hospital, ACTRI, La Jolla campus).
• Must have access to reliable means of transportation.
• Must be willing to carry and promptly respond to a pager/cell during working hours.