Clinical Research Coordinator

Overview

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 clinical trials in neuromuscular medicine, including conditions such as muscular dystrophy, neuropathy, and other rare myopathies.

The Clinical Research Coordinator 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. Plan, develop, and implement start-up procedures for multiple phase I–IV research studies in assigned disease teams, and lead, direct, and coordinate operational efforts. Ensure compliance with state and federal regulatory guidelines.

Oversee the quality of medical and clinical research data. Build and maintain regulatory documents from start-up to close-out. Provide direction and guidance to investigators. Educate and inform the public concerning ongoing clinical trials. Work closely with Sponsors, clinical trials organizations, and regulatory officials at federal and state levels.

Oversee the administration of clinical trials to ensure full regulatory and institutional compliance. Responsibilities include coordination and documentation of pharmaceutical-sponsored and investigator-initiated trials and protocols, protocol development, oversight of study execution, and adherence to Standard Operating Procedures. Design and develop case report forms for PI-initiated and Sponsor-funded protocols.

Responsibilities include development and ongoing maintenance of study-related documents and procedures in compliance with FDA regulations and sponsor requirements, including CROs and pharmaceutical companies. Oversee execution of protocols at the research site and monitor in-house staff to ensure FDA regulations and Good Clinical Practice standards. Create, refine, and regularly update Standard Operating Procedures. Oversee study recruitment strategies and implement innovative screening processes to enhance patient enrollment and improve trial processes.

Perform protocol-defined procedures as required. Independently collect and analyze scientific data for publication, identify new clinical trial protocols, train and monitor research personnel (including physical therapists, fellows, nurses, or other staff). Perform other duties as assigned.

• Strong theoretical knowledge and/or Bachelor’s Degree in a social or basic science (e.g., Biology, Microbiology) or an equivalent combination of education and 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, randomization and blinding, experimental protocols, data gathering, and data entry.

• Experience in start-up procedures for research protocols, including feasibility, activation, IRB processes, and qualification procedures.

• Experience performing clinical research duties in environments such as CROs, academic research institutions, or research hospitals.

• Experience providing work direction and supporting supervisors in maintaining an efficient medical research team.

• Strong knowledge of investigational protocols, data management, query resolution, and protocol implementation. Ability to manage multiple (>10) vendors on a single trial.

• Experience screening patients for eligibility, initiating treatment plans, collecting specimens, and orienting participating physicians.

• Strong experience completing clinical trial case report forms via hard copy and online platforms.

• Proven ability to find creative and innovative solutions to meet center needs. Resourcefulness and ability to leverage resources and University contacts.

• Ability to discern tasks that can be handled independently versus those needing supervisor input, with timely action.

• Working knowledge of medical and scientific terminology.

• Proven ability to problem solve and resolve conflict.

• Excellent organizational and prioritization skills to meet deadlines in a dynamic…