Under the supervision of the Principal Investigators, Clinical Research Manager, and Senior Study Coordinators, the Assistant Clinical Research Coordinator supports the day-to-day coordination of the Pediatric Epilepsy Center of Excellence clinical research portfolio. The position supports industry-sponsored and investigator-initiated clinical trials, including gene therapy, antisense oligonucleotide, and small-molecule studies, as well as prospective observational and longitudinal natural-history studies.
This is a hybrid role requiring a minimum of three days on site at the UCSF Mission Bay Campus each week. Working closely with senior coordinators, investigators, clinical teams, sponsors, and coordinating centers, the incumbent supports recruitment and retention, research visits, informed-consent preparation under investigator direction, data and regulatory documentation, research specimens, monitoring visits, and study start-up and closeout activities.
The role is family-centered, conducted under close supervision initially, with increasing independence with demonstrated competency. The research population includes infants, children, and adolescents with complex neurologic disorders, including epilepsy. The incumbent must be comfortable engaging warmly and professionally with children of all ages, including newborns and young infants, and with their parents and caregivers.
This role requires sensitivity to the demands placed on families managing medically complex conditions, excellent communication skills, and an ability to make research visits organized and family-centered. Responsibilities % of time (Nothing less than 5%) Essential Function (Yes/No ) Key Responsibilities (To be completed by Supervisor) 35% YES Participant and Family Coordination Supports screening, recruitment, retention, and research-visit coordination; schedules visits and follow-up, prepares study materials, and communicates with families and clinical teams to support organized, family-centered participation. 30% YES Data, Regulatory, and Documentation Support Under the direction of senior study staff, documents protocol-specified data generated during research visits on approved source forms, including questionnaires, visit forms, laboratory results, and procedure records; abstracts required data from the electronic health record and other approved records; and enters data into case report forms and study databases.
Performs routine completeness and consistency checks, addresses routine data queries within delegated procedures, and routes discrepancies requiring interpretation to senior coordinators or investigators. Maintains research charts, regulatory binders, and protocol-required records. Prepares documentation supporting regulatory submissions, continuing review, amendments, adverse-event reports, and protocol deviations for review and submission by authorized study staff. [SS1] [AN2] 20% YES Specimen and Procedural Coordination Coordinates protocol-specific research specimen workflows.
Duties may include preparing nonsterile collection, processing, and shipping supplies; confirming participant identifiers and protocol time points; arranging collection by appropriately qualified clinical staff; and labeling, logging, processing, storing, tracking, and shipping specimens as permitted by training, protocol, and institutional procedure. Maintains specimen-accountability and chain-of-custody records and promptly escalates collection, labeling, temperature, timing, or shipment deviations to senior study staff.
For study-related procedures, including investigational drug-delivery procedures in the operating room, supports non-clinical research coordination before, during, and after the procedure. Before the procedure, confirms that approved study documentation, research specimen kits, nonsterile study materials, labels, transport containers, and required contacts are ready. During and after the procedure, communicates protocol time points and research handoffs to the study and clinical teams, receives and transports research specimens or materials outside the sterile field as permitted, records protocol-required times and handoffs, and confirms delivery to the designated laboratory or storage location.
Coordinates with radiology, anesthesia, neurosurgery, nursing, pharmacy, laboratory personnel, and couriers as applicable. The incumbent does not make clinical decisions, direct clinical care, administer investigational products, or perform clinical or sterile-field duties unless separately qualified, credentialed, and authorized to do so. [SS3] [AN4] 15% YES Monitoring, Start-up, and Team Operations Prepares for sponsor monitoring visits, audits, study start-up and closeout, and collaborates with clinicians, nursing, pharmacy, laboratory personnel, sponsors, monitors, and study sites. 100% (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9.
The total sum should add up to 100%.) Required
High School Diploma; or equivalent experience Demonstrated ability to organize competing priorities, maintain accurate records, and manage detail-oriented work reliably and on time Strong written and verbal communication skills, including the ability to communicate respectfully and effectively with children, parents, caregivers, and multidisciplinary clinical and research teams Proficiency with standard office and data-entry applications and the ability to learn study databases, electronic health record systems, and other research tools Ability to work collaboratively in a fast-paced pediatric clinical environment, exercise sound judgment, maintain confidentiality, and follow approved protocols and institutional procedures Willingness to complete required training in human-subjects protection, Good Clinical Practice, privacy, and study-specific procedures For studies involving investigational drug delivery or other study-related procedures in the operating room, the incumbent may assist with non-clinical research coordination before, during, and after the procedure.
The coordinator must be comfortable working in the operating-room environment and adhering to all applicable infection-control, privacy, procedural, and safety requirements. Duties may include confirming study documentation, coordinating research samples or study materials, communicating with the procedural and clinical teams, and documenting protocol-required activities. The incumbent will not perform clinical or sterile-field duties unless separately qualified, credentialed, and authorized to do so
BS Degree in related science Prior experience in clinical research, research coordination, or a health-care setting, particularly within an academic medical center Experience working with pediatric patients and families, especially those affected by epilepsy, neurologic disorders, or other medically complex conditions Familiarity with clinical-trial operations, including participant screening and scheduling, informed-consent support, source documentation, regulatory files, and electronic data-capture systems such as REDCap Experience coordinating research specimens, including collection, processing, storage, and shipment in accordance with study procedures Comfort working in the operating-room environment in a non-clinical research-support role and following infection-control, privacy, procedural, and safety requirements Clinical Research Coordinator certification (e.g., ACRP or SOCRA) or interest in pursuing certification as experience permits
Full time · Day shift