Clinical Research Coordinator - 135390

The Department of Neurosciences at UC San Diego and Rady Children's Hospital (RCHSD) is seeking a motivated and experienced clinical research coordinator to support a team of investigators in the conduct of clinical research, although not limited to, clinical trials and observational studies in epilepsy, neuroimmunology, neurometabolic/mitochondrial disorders, multiple sclerosis, optic neuritis and other central nervous systems autoimmune diseases.

The incumbent will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, documentation, data entry, maintenance of participants and direct communication with patients and families. Create informational and recruitment materials and liaise with other UCSD and RCHSD departments and agencies to implement studies. The Clinical Research Coordinator will plan, develop, and implement start-up procedures for investigator-initiated studies federally funded research and phase I-IV clinical trials, in assigned disease teams, as well as lead, direct, and coordinate operational efforts. Assure compliance with state and federal regulatory guidelines. Interface with the Institutional Review Board (IRB) and assist with maintaining consent forms and other IRB-related matters. Oversee the quality of the medical and clinical research data. Build and maintenance regulatory documents consistently from start up to close out. Provide direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Work closely with Sponsor, clinical trials organizations, federal and state regulatory officials.

Oversee the administration of clinical trials and ensure full compliance with regulatory requirements, including ALCOAC+ principles, and institutional policies. Responsibilities include the coordination and documentation of pharmaceutical-sponsored and investigator-initiated clinical trials and protocols. Involve with protocol development, oversight of study execution, and ensuring that all study procedures adhere to Standard Operating Procedures. Design and development of case report forms (CFRs) for both PI-initiated and Sponsor-funded protocols.

Responsibilities include the development and ongoing maintenance of all study related documents and procedures in compliance with FDA regulations and sponsor requirements, including those from Contract Research Organizations (CRO) and pharmaceutical companies. This role will oversee execution of protocols to be conducted at the research sites; and the monitoring of the in-house research staff to ensure FDA regulations and Good Clinical Practice (GCP) standards.

This position will entail the creation, refinement and regular updating Standard Operating Procedures. Additionally, responsibilities will include oversee study recruitment strategies, including the development and implementation of innovative screening processes to enhance patient enrollment and improve clinical trial processes. The incumbent will be responsible for performing protocol defined procedures as required. Independently collecting and analyzing scientific data for publication, identifying new clinical trial protocols, training and monitoring research personnel; including imaging technicians, physical therapists, and other trainees, nurses and any other staff assigned to the incumbent protocols. This role requires proficiency with Velos, UCSD's mandatory clinical trials management system, used for tracking participant enrollment, scheduling, visit completion and conventional care coverage analysis.

The incumbent is also required to utilized Clinical Conductor for subject scheduling, and other electronic platforms used for management and maintenance of Site Files (ISF), as applicable. Perform other duties assigned.

• 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 for a minimum of 3 years, preferred. Strong knowledge of Good Clinical Practice (GCP), FDA regulations for clinical trials research, randomization and blinding procedures, experimental protocols, data gathering, and data entry.

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

• Experience with IRB submissions and Regulatory-Investigator Site File management experience.

• 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, data management, query resolution, protocol implementation. Able to manage multiple (>10) vendors assigned to a single clinical trial.

• 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 platforms.

• 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.

• Proficiency in written and spoken English.

• Computer proficiency, including typing ability, working knowledge of word processing, spreadsheet software (Microsoft Office) and applications.

• Demonstrated administrative experience, 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.

• Must be willing to interact with multiple investigators and work on a variety of research projects with adult and pediatric population.

• Strong organizational skills, the ability to manage competing priorities, and the flexibility to multitask effectively in a dynamic research environment.

• Adept at working with multiple investigators across a variety of research protocols

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

• Proficiency with Velos, UCSD's mandatory clinical trials management system, used for tracking participant enrollment, scheduling, visit completion and conventional care coverage analysis.

• Bilingual/Bicultural (English/Spanish)

• 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 different locations including: Rady Children's Hospital, Neurology Clinic, PACU, ACTRI - La Jolla and Linda Vista Clinics, UCSD Hillcrest and La Jolla campuses.

• Must have access to reliable transportation to coordinate research procedures conducted at various locations: CTRI (primary) and Rady Children's Hospital (secondary).