Regulatory Coordinator II - Cancer Center - Hybrid - 141849

UC San Diego; San Diego (CA); Hybrid; USD 85.000 - 137.000; Vollzeit

Zusammenfassung

UC San Diego's Moores Cancer Center is seeking a Regulatory Coordinator II for the Clinical Trials Office. The role develops and maintains regulatory documents for trials, ensuring IRB approvals and regulatory compliance across FDA, HHS, and UCSD IRB processes.

The position requires experience in clinical research environments, knowledge of NIH and GCP, and strong organizational and communication skills to coordinate with investigators and sponsors.

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 with knowledge of experimental protocols, data gathering, protocol design and evaluation.
• Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).
• Knowledge of NIH, GCP, IATA Shipping, and Bloodborne Pathogens.
• Experience coordinating with supervisors to maintain efficient research teams.
• Experience in clinical research environments (CRO, academic research, or research hospital).
• Experience working with FDA policies regulating clinical trials.
• Proficiency in Word, Excel, Velos, and internet browsing.
• Ability to find creative and innovative solutions to center needs.
• Ability to discern independent work from supervision.
• Working knowledge of medical/scientific terminology.
• Strong problem-solving and conflict resolution skills.
• Excellent organizational, written, and verbal communication skills.

Aufgaben

• Prepare and maintain regulatory documents for IRB submissions.
• Interpret and apply complex clinical research regulations (FDA, HHS, UCSD IRB, CTO).
• Coordinate with investigators and staff across multiple contacts.
• Assist supervisor in maintaining an efficient clinical research team.
• Perform regulatory duties within clinical trial environments.

Kenntnisse

Clinical trials research

Regulatory interpretation

Strong communication

Problem solving

Organizational skills

Independent judgment

Team coordination

Ausbildung

Bachelor's degree in related area

Master's degree in a social or basic science

Tools

Microsoft Office

Velos

Internet research

Jobbeschreibung

This position will work a hybrid schedule which includes a combination of working both onsite at Moores Cancer Center and remote.

DESCRIPTION

The Moores Cancer Center (MCC) is one of just 57 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County. As a consortium cancer center, it is a collaborative partnership between the UCSD: encompassing 28 departments, 6 schools School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, School of Public Health, Jacobs School of Engineering, School of Biological Sciences & the School of Physical Sciences), UCSD Health oncology hospitals and clinics; the basic and public health research and outreach of San Diego State University (SDSU), and the basic and translational research of the La Jolla Institute of Immunology (LJI). These various programs and units are all dedicated to fulfilling the Moores Cancer Center's mission of reducing cancer's burden. As such, it ranks among the top centers in the nation conducting the continuum of cancer research, providing advanced patient care, and serving the community through outreach and education programs. As a top-ranking, future-oriented organization, we offer challenging career opportunities in a fast-paced and innovative environment. Moores Cancer Center follows a progressive philosophy of career-path development for its employees including opportunities for cross-training, professional development, and progressive responsibility.

The Clinical Trials Office (CTO) at the Moores UCSD Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators.

Under general supervision of the Regulatory Affairs Manager, the Clinical Trials Regulatory Coordinator II is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators at the Cancer Center. Key to this role is the preparation of clinical trial protocols and related regulatory documents for submission to the UCSD Human Research Protections Program (UCSD's Institutional Review Board or IRB) in order to obtain its approval for the clinical trials to proceed. The Regulatory Coordinator II will act as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical trials, including those of the FDA, HHS, UCSD IRB, and the CTO. This position requires regular interaction with a variety of internal and external contacts including Cancer Center investigators and staff, UCSD IRB staff, study sponsors and/or their representatives. Other duties assigned as needed.

MINIMUM QUALIFICATIONS

• 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.

• Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).

• Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Office of IRB Administration (OIA), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.

• Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.

• Demonstrated experience performing clinical research duties in a clinical research environment such as a 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. Experience in conducting searches on the internet.

• 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.

• Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

PREFERRED QUALIFICATIONS

• Master's degree in a social science or basic science such as Biology, Microbiology or a related field.

• Possess a Clinical Research Coordinator Certificate (SoCRA or ACRP) or Regulatory Affairs Certification (RAPS).

• Fluency in English OR English and at least one of the following languages: Spanish, Korean, Vietnamese, Mandarin or Cantonese.

• Experience with cancer-related research.

• Knowledge with various types of human subject clinical trials i.e., National Group, Industrial, and Investigator-authored.

• Experience with clinical trial management systems and eRegulatory systems.

SPECIAL CONDITIONS

• Employment is subject to a criminal background check.

• Must be able to work various hours and locations based on business needs.

Pay Transparency Act

Annual Full Pay Range: $84,940 - $136,555 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $40.68 - $65.40

Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).