Clinical Research Coordinator - 134166

The Department of Neurosciences Division of Neurocritical Care is seeking a motivated and experienced clinical research coordinator to assist in-although not limited to-clinical trials in neurocritical care.

Responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, patient enrollment, data collection and assisting with analysis, ensuring protocol compliance, adverse event (and serious adverse event) reports, relevant laboratory/specimen submission, and maintenance of accurate and complete clinical research files for research participants within the division of neurocritical care. Additionally, liaise with ACTRI and research team members regarding follow-up of enrolled participants. Assist with verifying university research account statements, professional fee statements, and invoicing. Assist with Human subjects IRB submissions, amendments and renewals. It is expected that this individual will ensure compliance with state and federal regulatory guidelines, and oversee the quality of the medical and clinical research data in consultation with the supervising principal investigator. Directly communicate with assigned physicians and ICU teams, including attending meetings. Responsible for building and consistently maintaining regulatory documents.

• 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, including prior interactions with patients. Strong knowledge of Good Clinical Practice (GCP), basic regulations for clinical trials research, randomization and blinding procedures, experimental protocols, data gathering, and data entry.

• Demonstrated experience in research protocol procedures, including: study activation and IRB processes, and qualification procedures.

• Demonstrated experience performing clinical research duties in a clinical research environment.

• Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP).

• Strong knowledge of investigational protocols, data management, query resolution, protocol implementation.

• Demonstrated experience with research protocols in order to screen patients for eligibility, initiate treatment/intervention plan, collect specimens, and orient participating team members.

• Awareness of or experience in completing clinical trials case report forms via hard copy and online platforms.

• Demonstrated 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, preferably related to critical care, sleep or neurology.

• 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 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 typing ability, working knowledge of word processing, spreadsheet software (Microsoft Office)database entry (e.g., RedCap)and applications.

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

• Able to efficiently manage and respond to emails in a timely fashion.

• Current UCSD employee preferred.

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

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

• Very occasional evenings and /or weekends may be required.

• Must have access to reliable transportation to travel to different locations (Hillcrest Medical campus, ACTRI, La Jolla medical campus).

• Must be able and willing to readily communicate by phone and/or email and respond quickly to inquiries regarding potential participants given the nature of the enrollment timeline following acute brain injury.