Hybrid Regulatory Coordinator II – Clinical Trials

University of California San Diego; San Diego (CA); Hybrid; USD 85.000 - 137.000; Vollzeit

Zusammenfassung

The Moores UCSD Cancer Center at University of California San Diego is seeking a Regulatory Coordinator II to manage regulatory documents for oncology trials. This role supports submission to the UCSD IRB and collaborates with investigators, staff, sponsors, and regulatory bodies to ensure compliance.

Hybrid work arrangement combines onsite at Moores Cancer Center with remote work. Ideal candidates will have extensive clinical trials experience, knowledge of FDA policies, and strong

Qualifikationen

• Six years of related experience, education/training, OR a Bachelor’s degree in related area plus two years of related experience/training.
• Demonstrated experience in clinical trials research.
• Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.
• Knowledge of NIH, GCP, IIPP, OIA, IATA Shipping of Blood Specimens, and Bloodborne Pathogens.
• Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.
• Experience in clinical research duties in CRO, academic research institution, and/or a research hospital.
• Experience working with FDA policies regulating clinical trials.
• Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office, Velos) and internet browser applications.
• Proven ability to find creative and innovative solutions to adjusting needs of the center.
• Ability to discern items that can be handled independently and those requiring supervisor attention.
• Working knowledge of medical and scientific terminology.
• Proven ability to problem solve and resolve conflict.
• Excellent ability to organize/prioritize workload and meet deadlines with interruptions.
• Excellent interpersonal, written and verbal communication skills.
• Demonstrated administrative experience coordinating complex activities.

Aufgaben

• Develop and maintain regulatory documents for MCC clinical trials.
• Prepare clinical trial protocols and regulatory documents for UCSD IRB submission.
• Interpret and apply complex clinical research regulations, policies & procedures.
• Interact with investigators, staff, IRB staff, study sponsors and representatives.
• Other duties as needed.

Kenntnisse

Clinical trials research

GCP

IRB processes

Regulatory affairs

FDA policies

MS Office

Communication skills

Organizational skills

Problem solving

Team coordination

Ausbildung

Bachelor’s degree in related area

Master’s degree in life sciences

Tools

Velos

MS Office

Internet browsers

Jobbeschreibung

The Moores UCSD Cancer Center at University of California San Diego is seeking a Regulatory Coordinator II to manage regulatory documents for oncology trials. This role supports submission to the UCSD IRB and collaborates with investigators, staff, sponsors, and regulatory bodies to ensure compliance.

Hybrid work arrangement combines onsite at Moores Cancer Center with remote work. Ideal candidates will have extensive clinical trials experience, knowledge of FDA policies, and strong