Clinical Research Coordinator - 135292

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 neuromuscular medicine which includes conditions such as muscular dystrophy, neuropathy and other rare myopathies.

The incumbent will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, documentation, data entry and maintenance of subjects. Create informational and recruitment materials and liaise with other UCSD departments and agencies to implement studies. The Clinical Research Coordinator will plan, develop, and implement start-up procedures for multiple phase I-IV research studies in assigned disease teams, as well as lead, direct, and coordinate operational efforts. Assure compliance with state and federal regulatory guidelines. 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 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. Oversee execution of protocols to be conducted at the research site; and the monitoring of the in-house research staff to ensure FDA regulations and Good Clinical Practice (GCP) standards. Create, refine, and regularly update Standard Operating Procedures. Oversee study recruitment strategies, including the development and implementation of innovative screening processes to enhance patient enrollment and improve clinical trial processes. Perform protocol defined procedures as required. Independently collect and analyze scientific data for publication, identifying new clinical trial protocols, training and monitoring research personnel; including physical therapists, fellows, nurses or any other staff assigned to the incumbent protocols. 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. 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.

• 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.

• 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.

• Proficiency in written and spoken English.

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

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

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

• 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 (Rady Children's Hospital, ACTRI, La Jolla campus).

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