Bachelor of Arts/Bachelor of Science
2 Years of Experience Required
With supervision, the Study Coordinator II may support a phase 1 or 2-4 Clinical Study. Their primary role is administrative support. They may assist in the development and upkeep of administrative support tools for the research team including set-up, maintenance and reconcilliation of the clinical research binders for studies, they serve as the point of contact for study sites and monitors, they assist research team with study set-up (preparation of study materials, meeting planning, etc), develop and keep tracking program up to date with study initiation and enrollment details, assist with IRB submission and complete study budgets.
Exciting opportunity to coordinate a range of FDA regulated Observational, Phase 1, 2, or 3 industry sponsored clinical trials investigating novel, first in class, lifesaving/sustaining/altering pharmaceutical therapies for rare lysosomal storage diseases ranging from classic biologics to gene therapy. These trials will provide basis for FDA drug approval.
Over the last ten years our research group has contributed to FDA approval of 5 lifesaving therapies for Rare Diseases. Our Research Program involves close interaction with patients and their families who are recruited from diverse areas of the world. We encourage and support Society of Clinical Research Associates (SOCRA) and/or Association of Clinical Research Professionals (ACRP) certification, certification renewals and ongoing CRC educational programs.
Education: Bachelor's Degree in relavant scientific discipline, or Associate's Degree plus two or more years of experience as a Study Coordinator. CRA preferred.
Experience: Minimum 2 years experience in study support in relavant scientific discipline or experience in clinical role with RT, LVN, RN or similar licensure/certificate plus study experience.
Skills & Abilities: Demonstrates an ability to apply knowledge of aministrative support for the research team and it's interaction with clinical functions.
Demonstrates an understanding of the science behind the clinical operations. Demonstrates an ability to lead. Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP's governing clinical trials.
Microsoft Office Suite, or MAC equivalent. CCRC or in process of CRC certification preferred.
Sit: Up to 8 hours/day
Stand/Walk: 3-6 hours
Bend/Stoop: Up to 3 hours
Reach: Up to 3 hours
Rep Use of UE/Grasp: Up to 8 hrs
Lift/Push/Pull: 15 to 25 lbs
This job requires the ability to hear alarms clients and/or instruction. The ability to see accurately from 20 inches to 20-ft. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this position.
UCSF Benioff Children's Hospital Oakland is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. UCSF Benioff Children's Hospital Oakland seeks candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence, and the communities we serve.
Children's Hospital & Research Center