Clinical Research Coordinator – Melanoma and Cutaneous Oncology Program

About the role

The Cutaneous Oncology clinical research team supports a diverse portfolio of studies for melanoma and non-melanoma skin cancers, including squamous cell, basal cell, and Merkel cell carcinomas. The team partners with specialists across Dermatology, Medical Oncology, Surgical Oncology, and Radiation Oncology to provide comprehensive, multidisciplinary care. Our focus includes outpatient, therapeutic cancer clinical trials in phases I–III, including both industry-sponsored and investigator-initiated studies. We also manage noninterventional studies aimed at improving early detection, risk assessment, and long-term survivorship.

Responsibilities

• Independently, or with general direction, execute, manage, and coordinate clinical research protocols, as directed by the Clinical Research Manager, Principal Investigator (PI), and/or the Associate Director of Clinical Research Programs for the Early Phase program.
• Coordinate the administrative, data, and patient scheduling operations of several concurrent clinical research studies under the guidelines of research protocols and regulatory policies.
• Support the management and coordinating the tasks of single or multiple clinical research studies.
• Manage and update databases to ensure data integrity.
• Act as intermediary between sponsors, research staff, and various UCSF departments.
• Help assure compliance with all relevant regulatory agencies.
• Maintain relevant regulatory documents in partnership with the Regulatory department.
• Report study progress to investigators.
• Participate in any internal and external audits or reviews of study protocols.
• Perform other duties as assigned.

Requirements

• High School Diploma; or equivalent experience
• Attention to detail
• Strong interpersonal skills
• Excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions
• 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

Qualifications

• Required Qualifications:
• High School Diploma; or equivalent experience
• Attention to detail
• Strong interpersonal skills
• Excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions
• 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
• Prior analytical and writing skills in a science/research environment
• Fluency in the usage of Committee of Human Research (CHR) online iMEDris system 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
• Experience with electronic medical records
• 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
• Demonstrated knowledge and understanding of research, especially in the areas of biological sciences
• Prior experience with various computer programs (Microsoft Office; internet-based databases)
• 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
• Familiarity with specimen processing, or demonstrated ability to learn specimen processing in a laboratory environment
• Working knowledge of, or demonstrated ability to learn federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting
• Knowledge of medical terminology, and/or the ability to apply information to the assessment, interpretation, and processing of medical data
• The 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
• The ability to work with a sensitive population of patients (oncology patients)
• 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