Clinical Research Coordinator - Early Phase Program

About the role

The Early Phase program has a multi-disciplinary team that works closely with patients, providing the resources and close cooperation of many specialists with deep expertise in diagnosing and treating early and late-stage cancer. Our physician-scientists are also researching and developing new and effective treatments for cancer, including clinical trials. The Early Phase program is seeking a Clinical Research Coordinator with an interest in investigational drugs to have oversight over multiple clinical research projects and support our growing program.

Responsibilities

• Study Coordination, Implementation, and Data Collection
  • Work with the PI, Lead CRC, and research team to identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects;
  • Prepare protocols for initiation, which includes working knowledge of federal, state, and local research regulations and guidelines, and cancer center clinical practice methods;
  • Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures;
  • Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary;
  • Discuss study outcomes with providers to ensure continuity of care;
  • Review information with subjects; assess and advocate for patient safety throughout each protocol procedure.
• Data management, reporting of results, and quality control
  • Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies;
  • Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner;
  • Collect, report and manage data for patients on follow-up in a timely manner;
  • Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed;
  • Create and maintain study source documentation, tracking of blood/tissue samples, and other protocol activities to ensure compliance;
  • Create and maintain comprehensive data sets as requested by the Lead CRC and/or PI.
• Specimen Management/ Maintenance
  • Ensure that specimens are properly processed, stored, and shipped according to all laboratory policies and safety measures;
  • Arrange the exchange of and transport of specimens with collaborating Investigators and staff;
  • Ensure integrity and security of samples.
• Regulatory Responsibilities
  • Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations;
  • Initiate and follow-up on iMEDris submissions for single-patient exceptions, adverse event reporting, and protocol violations;
  • Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments;
  • Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments;
  • Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.
• Other duties
  • Assist the Supervisor to train staff and peers, and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures;
  • Attend and actively participate in regular team meetings as well as professional development opportunities;
  • Must be a team player and participate in staff-wide assignments outside of protocol management, including: filing, cleaning and maintaining study supplies, maintaining common work spaces (office space and laboratory space); development of policies and procedures, and other duties as assigned by the Lead CRC, Principal Investigator, and Research Personnel Manager.

Qualifications

• High School Degree
• 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.
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• Prior experience with various computer programs (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 knowledge of research or training experience that translates into a clinical research setting.
• Familiarity with specimen processing
• Working knowledge of federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting
• Ability to apply relevant information to the assessment, 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
• Ability to work with a sensitive population of patients (oncology patients)