Job DescriptionSUMMARY STATEMENTUnder the direction of the Senior Research Director, Financial Administrative Office (FAO), Faculty Director, Medical Director, (Senior Management), of the Clinical Research Unit (CRU) within the Division of Hematology/Oncology, the Community Practice Clinical Research Associate (CRA) will be primarily responsible for the coordination of research activities under the direct supervision of the Community Practice Senior Manager.
S/he will be responsible for ensuring protocol procedures are completed accurately, safely, and in a timely manner, this includes responsibility for research assessment and patient intervention under the supervision of the Principal Investigator.
Additional responsibilities include regulatory compliance, patient recruitment and enrollment, data collection, research chart documentation, quality assurance, report preparation, protocol information dissemination to health care professionals, patients and their family members.
S/he will ensure investigational product (IP) is adequately managed and documented.
Meet with staff on an annual basis to develop and implement career goals in order to encourage and promote professional growth and development.
Travel to other locations may be required.TYPE OF SUPERVISION RECEIVEDIncumbent sets priorities based on research needs and requirements, completing responsibilities using CRU and research regulatory guideines.
Supervisor gives assignments but incumbent is expected to use judgement to determine most appropriate method of completing research projects.
Work will be reviewed periodically or when deviating from standard procedures.
AMOUNT OF TIME DUTIES AND TASKS 65% A.
Clinical Research Coordination/Data Management 1.
Perform patient registration activities including: 1) ascertaining pre-treatment and eligibility requirement of the protocol have been met, including informed consent and insurance authorization prior to registration; 2) register/randomize patients referred for protocol, and 3) document record of patient registration, data and treatment assignment; 2.
Compile protocol data, including maintaining protocol patient logs, screening logs and statistics; 3.
Assisting in the collection and documentation of data when required; 4.
Ensuring the collection and submission of data to sponsoring agency to meet protocol requirements, this includes lab, surgery, treatment, pathology; x-ray, operative reports, radiotherapy forms and films, or other outside information required for protocol purposes; 5.
Maintaining source documentation on protocol patients, including: all clinic notes (Physician, nursing staff and research staff notes); adverse events and concomitant medication logs, dosage modifications and treatment calculations; 6.
Meet with faculty and staff for training and regularly review patients; 7.
Assist in quality control and quality assurance activities, including: review of protocol study forms for completeness and accuracy; reviewing materials for quality assurance guidelines; audit information for errors, and ensure timelines of data submission; gather materials for site visits; 8.
Attend Oncology Program meetings as needed to identify potential protocol patients; 9.
Alert investigators and appropriate personnel of communications regarding adverse drug reaction reports, and treatment complications; 10.
Perform research assessments and interventions under the direction of the Principal Investigator, where appropriate, with research patients; 11.
Ensure all protocol related activities outlines in the protocol are executed according to the study and regulatory guidelines; 12.
Ensure all study patients are entered and up-to-date in the clinical trials management system (CTMS); 13.
Under the direction of the Principal Investigator, act as a second coordinator reviewer of the protocol enrollment criteria, as needed by the enrolling Sub-Investigator and research staff; 20% B.
Administration/Training 1.
Assist if needed in designing of forms to be used for data collection, monitoring patient care and documenting research activities; 2.
Periodically review investigational drug logs and inventories with Investigational Drug Services (IDS) to assure appropriate documentation is maintained; 3.
Dissemination of information to site sub-investigators, clinic staff and nurses on their role in protocol participation; 4.
Discuss study timetables and calendars with patients to assure protocol compliance; 5.
Meet with site sub-investigators, and other personnel to discuss new protocols, patients and patient treatment issues and to assist the investigator with identifying potential study candidates; 6.
Participate in continuing education activities, presentation or seminars related to research and data management, cancer and other areas to gain knowledge to improve job performance; 7.
Participate in training of new staff as required by the team; 8.
Attend Investigator’s meetings as required; 10% C.
Communications 1.
Act as liaison between other hospital and clinic departments including Surgery, Radiology, Clinical Labs, Pathology, Clinical Research Center, and Sponsored Research; 2.
Act as liaison between study sponsors, regulatory agencies, including the FDA, NCI and IRB; 3.
Triage patient phone calls and refer to appropriate persons for resolutions of problems/ questions; 5% D.
Service Excellence 1.
Responsible for being customer-centered in all aspects of the aforementioned duties, and for continuously measuring, evaluating, and responding to the needs of customers; patients and their families/visitors, payers, physicians, and each other as internal suppliers of services.
Provision of service excellence requires: actively streamline processes to maximize customer satisfaction and provide timely and responsive services; providing courteous, helpful and sensitive service to customers; and listening to, informing and involving customers as partners in the delivery of service.
Use mouse to move to next section.
Use tab key within section.
SKILLS, KNOWLEDGE AND ABILITIES TASK REFERENCE IMPORTANCE 1.
Demonstrated clinical research experience, including working knowledge of good clinical practices for clinical research.
All Required 2.
Ability to work in more than one environment, travel to participating hospitals, and attend off site staff meetings, conferences and investigator meetings.
All Required 3.
Ability to work efficiently and complete tasks with a high degree of accuracy.
4.
Demonstrated organizational skills to handle multiple clinical research projects for efficiency and cost-effectiveness, including handling work delegated by more than one individual.
5.
Excellent English verbal and writing communication skills to convey and obtain information to and from investigators, patients, families, sponsors and co-workers.
6.
Effective interpersonal skills to interact professionally and diplomatically with patients, families, sponsors, co-workers, investigators and others.
7.
Demonstrated skill in prioritizing workflow to meet deadlines, often under pressure of conflicting demands, while maintaining accuracy and effectiveness of work.
8.
Demonstrated computer skills using Word, Excel, email and databases to create reports, correspondence and other documents as required.
All AllAll All All All Required RequiredRequired Required Required Required 9.
Ability to travel between multiple sites to provide coverage and assistance to staff and faculty as required.
10.
Valid California State Driver’s License and car to travel between research sites.
All AllRequired Required