Oncology Clinical Trials Lead Coordinator

University of California - San Diego Medical Centers; San Diego (CA); On-site; USD 85,000 - 137,000; Full time

Job summary

The Clinical Research Coordinator II at University of California - San Diego Medical Centers will manage start-up procedures for multiple phase I-III trials, coordinate recruitment and enrollment, and ensure regulatory compliance. The role includes creating recruitment materials, directing study operations, and collaborating with investigators and regulatory bodies.

Responsibilities also cover data quality oversight, preparing proposals and manuscripts, and educating the public about ongoing

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.
• Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.
• Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.
• Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.
• Strong knowledge of investigational protocols especially with oncology protocols (data management, query resolution, protocol design, protocol writing and protocol implementation).
• Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.
• Strong experience completing clinical trials case report forms via hard copy and online.
• 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. Excellent phone etiquette skills.
• Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience in conducting searches on the internet.
• Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

Responsibilities

• Coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects.
• Create informational and recruitment materials and act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies.
• Plan, develop and implement start-up procedures for multiple phase I-III research studies in assigned disease team as well as lead, direct, and coordinator operational efforts.
• Assure compliance with state and federal regulatory guidelines.
• Oversee the quality of the medical and clinical research data.
• Provide direction and guidance to investigators.
• Provide education and information to the general public concerning the ongoing clinical trials.
• Assist PIs with proposals, progress reports and manuscripts.
• Independently create original documents and policies for assigned disease teams.
• Work closely with federal and state regulatory officials.

Skills

Fluency in English

Spanish

Korean

Vietnamese

Mandarin

Cantonese

Microsoft Office

Internet research

Education

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

Clinical Research Coordinator Certificate

Tools

Microsoft Office

Job description

The Clinical Research Coordinator II at University of California - San Diego Medical Centers will manage start-up procedures for multiple phase I-III trials, coordinate recruitment and enrollment, and ensure regulatory compliance. The role includes creating recruitment materials, directing study operations, and collaborating with investigators and regulatory bodies.

Responsibilities also cover data quality oversight, preparing proposals and manuscripts, and educating the public about ongoing