Research Coordinator II

University of Southern California•Los Angeles, CA

1d•$35 - $42

About The Position

USC Norris Comprehensive Cancer Center’s Clinical Investigations Support Office (CISO) is seeking a Research Coordinator II to serve as a lead in coordinating clinical research activities, including study recruitment, scheduling study-related tests, and following up with enrolled patients. The Coordinator works independently and collaborates with physicians, patients, peers, data managers, and other hospital personnel. The role is accountable to the Medical Director and Associate Director of CISO, as well as to the Principal Investigators with whom the Coordinator works. The Coordinator is expected to know and follow the policies and procedures of the hospital where they work. The position supports clinical research from protocol review and planning through patient enrollment, protocol compliance, safety reporting, specimen handling, data collection, and study closeout activities. It involves determining eligibility, obtaining and managing informed consent, coordinating clinical assessments and treatment, monitoring toxicities and adverse events, maintaining study documentation, and working with investigators, patients, hospital staff, research pharmacists, laboratories, and sponsors. The Coordinator may also assist with audits, study-result preparation and publication, and training less-experienced coordinators. The position requires a bachelor’s degree, at least two years of experience, and prior experience as a Protocol Coordinator in clinical oncology research. The hourly rate range is $34.86–$41.56. USC states that it considers factors including responsibilities, experience, education, skills, internal equity, applicable laws, funding, and market and organizational considerations when making an employment offer.

Requirements

Bachelor’s degree.
At least 2 years of experience; preferred experience is 3 years.
Prior experience as a Protocol Coordinator in clinical oncology research.
Strong medical background; foreign medical graduate is desirable.
Administrative or research experience.
Knowledge of the medical environment and medical terminology.
Knowledge and understanding of federal, state, and institutional research regulations, Good Clinical Practices (GCP), and HIPPA regulations.
Proficiency with MS Office applications.
Demonstrated effective communication and writing skills.
Ability to multitask.
Ability to work independently with minimal supervision and as part of a team.
Ability to work well with many people and across different disciplines.
Completion of Human Subject Training, HIPPA, GCP, and Sexual Harassment online courses.
Completion of Blood Bourne Pathogens online class and obtaining a shipping certificate.

Nice To Haves

Foreign medical graduate background.
Three years of experience.
Staff education and orientation experience.
Knowledge of Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS).

Responsibilities

Review new protocols before committee approval when requested, focusing on the feasibility and necessity of study tests, treatment and dose modification, toxicities, and effort needed for budget setup.
Assist with planning and staffing project operations based on research activities and timelines; provide guidance to investigators, study personnel, and patients.
Communicate with the study team to support conduct of the study according to the protocol and assess protocol deviations and violations.
Participate in NCI, FDA, and pharmaceutical audits; follow applicable regulations and report Serious Adverse Events promptly, including entering SAEs in iStar and notifying the Data Manager.
Interact with sponsor monitors and auditors.
Enter patient registration and treatment-response information into the CAFE database, keep the Data Manager informed of patient study status, and help generate study results and prepare publications when requested.
Assist with training and demonstrating techniques or procedures to less-experienced coordinators.
Determine patient eligibility after consent; obtain correct IRB-approved informed consent, answer patient questions, and distribute and file consent documents as specified.
Complete protocol-specific data-management forms and tools, maintain research folders, schedule required tests, and calculate drug doses based on body surface area, recalculating when toxicity-related dose modifications are required.
Ensure appointments, admissions, follow-up tests, procedures, treatment records, and outside laboratory results are coordinated and obtained in accordance with the protocol.
Record toxicities accurately and ensure Serious Adverse Events are reported according to FDA timelines.
Maintain investigational-drug logs with the Research Pharmacist; obtain and transport investigational drugs to LAC General Medical Center when needed, return unused drugs within 24 hours, and follow CISO procedures for oral drug accountability.
Coordinate clinical-trial-unit admissions and research blood draws; complete specimen request slips, process and store samples appropriately, and arrange compliant packing, transport, and shipping of research specimens.
Ensure Quality of Life questionnaires are completed when applicable and obtain and document source data needed for Clinical Research Forms; complete some forms when assigned and follow CISO standard operating procedures.
Discuss eligibility and patient concerns with physicians and investigators, act as a liaison regarding medical problems, communicate SAEs and other patient problems, and raise toxicities or protocol issues that may require revision.
Ensure tumor measurements are obtained, calculate responses, and obtain physician signatures on Tumor Flow Sheets.
Screen potential participants when requested, coordinate pre-study evaluations, assess baseline symptoms and psychosocial needs, educate patients about potential toxicities, and serve as an initial contact for study-related problems and questions.
See patients at visits to assess, document, and report adverse reactions; ensure the treating physician reviews and countersigns Toxicity Assessment Forms and that dose modifications are made when necessary.
Serve as a resource for protocol questions and communicate patient concerns to nurses, social workers, and home health coordinators.
Work with pharmacists and nurses to support safe and accurate administration of protocol agents; coordinate specimens with hospital and destination laboratories and coordinate CTU admissions, orders, PI signatures, and sponsor lab kits.
Collaborate with other disciplines and clinics to recruit patients and conduct clinical trials; follow hospital regulations and complete Research Order Forms after visits for billing.
Arrange peer coverage during absences and contact the CISO Associate Director for assistance when coverage cannot be arranged.
Complete required Human Subject Training, HIPPA, GCP, Sexual Harassment, Blood Bourne Pathogens, and shipping-certificate training.
Perform other related duties as assigned or requested.