Cancer Center of Santa Barbara

Responsible for data management and coordination of patient treatment activities adhering to established clinical trial. Completes case report forms (CRFs) based on research subject and study data, prepares for monitoring visits, resolves data queries, and other duties as specified. Provides support and follow-up on clinical trial protocols. Works closely with community oncologists related to research activities.

SUPERVISION RECEIVED: Reports to the Director of Research and Quality Services and/or Clinical Research Lead

SUPERVISION EXERCISED: None

TYPICAL PHYSICAL DEMANDS: Requires prolonged sitting, some bending, stooping, walking and stretching to include lifting charts weighing up to 20 pounds. Requires eye-hand coordination and manual dexterity sufficient to operate office equipment. Requires normal range of hearing and eye sight to record, prepare and communicate appropriate reports. Requires good penmanship to write in small protocol designed forms.

TYPICAL WORKING CONDITIONS: Normal office environment in a variety of locations and various medical oncology treatment settings. Occasional evening or weekend work. Occasional travel to UCLA required.

EXAMPLES OF DUTIES: (This list may not include all of the duties assigned.)
1. Works closely with physicians, nurses and other health care professionals to identify patients for clinical trials.
2. Responsible for implementation, data management, and follow-up of clinical trials to assure data accuracy, patient safety, protocol compliance, and regulatory compliance as required by the clinical trial protocol, the study sponsor, and good clinical practice (GCP).
3. Responsible for informed consent process, adverse event monitoring and reporting according to protocol guidelines, and coordinating research activities of patients.
4. Responsible for specimen collection, processing, and shipping as required by clinical trial protocol.
5. Obtains all required source documentation to verify eligibility, protocol compliance, procedures performed, and patient status from both internal and outside sources for data reporting on CRFs.
6. Prepares and maintains accurate and complete research charts and ensures availability for monitors and/or audits.
7. Assists in quality control and quality assurance activities including internal, sponsor, and Federal Drug Administration (FDA) audits.
8. Works directly with monitors to resolve protocol and data-related issues.
9. Communicates study amendments and protocol deviations to the appropriate regulatory agencies.
10. Acts as liaison between study sponsors, regulatory agencies, including FDA, National Cancer Institute (NCI), and various Institutional Review Boards (IRB).
11. Ensures appropriate IRB documentation to include approvals, revisions, renewals, and addition of new investigators.
12. Responsible for drug accountability including ordering, distributing, and returning drugs to appropriate source when necessary. Ensures that records are being maintained,.
13. Researches topics, secures protocol information, and compiles reports from data and existing records.
14. Supports the research team through participation in continuous process improvement, active participation in department meetings, and participation in training of new personnel. Develops tools to expedite accurate clinical documentation and record keeping.
15. Participates in professional development activities to keep current with health care and research trends and practices.
16. Participates in outreach and informational programs to educate community about research opportunities.
17. Attends meetings as requested.
18. Handles confidential matters concerning clinic policies and practices in accordance with HIPAA regulations.
19. Performs related work as required.

PERFORMANCE REQUIREMENTS:
Knowledge, Skills & Abilities:
Knowledge of clinical trial protocols. Knowledge of IRB documentation and submission requirements. Skill and experience at interpreting medical charts and abstracting data from medical records. Ability to organize and coordinate multiple patients’ research activities to adhere to protocol requirements. Ability to use computer systems and technology for all aspects of clinical trials including but not limited to data management, coordination of patient activities and follow up. Ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently. Ability to work as part of a team and independently. Requires strong written, verbal, and problem solving skills. Clinical experience required and oncology experience a plus. Bachelor degree in science or related field and experience preferred.

Since 1949, the Cancer Center of Santa Barbara has remained in the vanguard of comprehensive outpatient cancer treatment with personnel from some of the nation’s renowned medical programs, the latest science and technology, and integrative wellness and patient support programs. The independent and charitably supported Cancer Center of Santa Barbara has earned a reputation for compassionately serving those on the journey to live with, through, and beyond cancer. www.ccsb.org