Clinical Research Coordinator - Berkeley, United States - University of California System

Description

The Helen Diller Family Comprehensive Cancer Center (HDFCCC) Clinical Research Network Office is seeking a Clinical Research Coordinator (CRC) to support the I-SPY Program at UCSF Cancer Center Berkeley.

UCSF is the lead site for the I-SPY Program; the program involves novel trial designs in the setting of neoadjuvant chemotherapy to accelerate the drug development process.

Our goal is to introduce and rapidly test novel targeted strategies for women at high risk for recurrence, at the time of primary cancer diagnosis, rather than waiting until they develop metastatic disease.

Neoadjuvant therapy allows visualization of tumor response to treatment, and thus is the ideal platform to identify mechanisms of resistance, develop diagnostic markers, and individualize therapy.

I-SPY 2, a phase 2 adaptive randomization trial process that will test up to 12 new drugs in approximately 800 patients over 5 years.

I-SPY 2 is a unique public/private partnership between QuantumLeap Healthcare Collaborative and the National Cancer Institute (NCI), the Food and Drug Administration (FDA), patient advocates and over 40 major cancer research centers across the United States and Canada.

The CRC will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator, Program Director, and Clinical Research Manager (CRM).

I-SPY 2 is a large trial consisting of up to eight different treatment regimens, two correlative science trials, a registry trial, and a quality of life study.

The CRC will be responsible for the coordination of the I-SPY 2 TRIAL, which will involve the following: prepare protocol applications and informed consent forms for IRB submission, help design flow sheets, data forms and source documents; gather and interpret medical, surgical and laboratory data regarding clinical trial/study subjects; apply understanding of inclusion/exclusion eligibility criteria for protocols; recruit, enroll, register, schedule and retain study subjects; record protocol specific treatments and adverse events and schedule/coordinate lab and pathology sample collection (requesting pathology samples) and shipment of samples; administer questionnaires/surveys in the clinical research center, assist research personnel to keep patients on study schedules; complete study forms to submit to sponsors and/or appropriate agencies; collect, enter and clean data into study databases, maintaining data quality; assist with data analysis; assist with preparation of reports and tables; attend team meetings; and perform other duties as assigned.

An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.

For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the 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.
• Demonstrated knowledge and understanding of research, especially in the areas of biological sciences
• Prior experience with various computer program (Microsoft Office; internet-based databases) and using specialized software such as OnCore.
• Ability to sit and work at a computer for several hours per day. May need to travel between one or more campuses via UCSF shuttle. Ability to stand for several hours of the day.
• Experience in clinical research or demonstrated research or training experience that translates into a clinical research setting
• Working knowledge of federal, state, and local research Required regulations and guidelines, and research practice methods in a laboratory or clinical setting
• Ability to apply relevant information to the assessment, Required interpretation, and processing of medical data.
• Ability to independently interpret and apply policies, respond to requests, resolve issues, and provide assistance to faculty and staff at all levels in a team- oriented environment

• Fluency in the usage of IRB online system, iRIS, for submission, renewal, and modification of protocols through this system.
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
• Experience with electronic medical records.
• Knowledge of location specific 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
• Effective Cash Handling Procedures
• Environmental Health and Safety Training
• Fire Safety Training
• Ability to work with a sensitive population of patients (oncology patients)
• Prior analytical and writing skills in a science/research environment
• Knowledge of clinical research in oncology
• Knowledge and experience in managing oncology clinical trials.
• Membership in a clinical research professional society.
• 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