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Program Management Office Clinical Research Coordinator

JOB SUMMARY |

The central Clinical Research Coordinator (CRC) is based at the Program Management Office (PMO). He/she will report directly to the central Project Manager, and will work closely with the Communications and Recruitment Manager, site study coordinators, and site project managers. The CRC is primarily responsible for managing the day to day aspects of the trial across all study sites – including supporting the site PI to run the trial, managing communications with participants that are on study or being proposed for participating, acting as the protocol expert for the site-wide team, managing accrual and data collection requirements, adhering the regulatory and safety requirements, and working with the research assistants supporting the trial.

A primary focus of the position will be providing direct support to study participants via phone and email. The CRC will answer participant study-related questions, triage clinical questions to Breast Health Specialists, and provide overall support and coordination to the central and site study staff members. Additional responsibilities will include overseeing IRB approval for the study, maintaining site-wide IRB approval records for the duration of the trial and coordinating all Stakeholder and External Advisory Board meetings throughout the duration of the trial.

ABOUT UCSF

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. 

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REQUIRED QUALIFICATIONS |

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities

• Excellent interpersonal, oral and written communication skills and the ability to interface with all levels of staff and leadership
• Ability to multi-task in a fast-paced environment while working with a diverse subject population
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines

 

PREFERRED QUALIFICATIONS |

• BA/BS degree with a major in a related field and two years of experience in administrative analysis or operations research; or an equivalent combination of education and experience
• In-depth understanding of clinical trials research
• Fluency in the usage of IRB online iRis system for submission, renewal, and modification of protocols through this system. Experience with UC-wide Reliance Registry a plus
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation
• Knowledge on how to collect trial data while protecting human subject safety in accordance with HIPAA and PHI policy
• Experience with electronic data capture systems, including electronic medical records systems
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding...

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REQUIRED QUALIFICATIONS |

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities

• Excellent interpersonal, oral and written communication skills and the ability to interface with all levels of staff and leadership
• Ability to multi-task in a fast-paced environment while working with a diverse subject population
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines

 

PREFERRED QUALIFICATIONS |

• BA/BS degree with a major in a related field and two years of experience in administrative analysis or operations research; or an equivalent combination of education and experience
• In-depth understanding of clinical trials research
• Fluency in the usage of IRB online iRis system for submission, renewal, and modification of protocols through this system. Experience with UC-wide Reliance Registry a plus
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation
• Knowledge on how to collect trial data while protecting human subject safety in accordance with HIPAA and PHI policy
• Experience with electronic data capture systems, including electronic medical records systems
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.)
• Knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and TeleForm programming platforms
• Experience applying the following regulations and guidelines:
Good Clinical Practice Guidelines
Health Information and Accountability Act (HIPAA)
The Protection of Human Research Subjects
CHR regulations for recruitment and consent of research subjects
Experience working with all regulatory aspects of clinical trials (including FDA, NCI, local IRB, and sponsor)

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