Research Coordinator II

University of Southern California•Los Angeles, CA

About The Position

USC Norris Comprehensive Cancer Center’s Clinical Investigations Support Office (CISO) is seeking a Research Coordinator II to lead and coordinate aspects of clinical research, 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 position is accountable to the Medical Director and Associate Director of CISO and 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 role includes reviewing protocols for feasibility and operational considerations, supporting study planning and staffing, guiding investigators and study personnel, monitoring protocol compliance, and assisting with audits and study reporting. The Coordinator manages patient consent and eligibility processes, schedules tests and follow-up, supports investigational drug accountability, coordinates research blood draws and specimen handling, and ensures study data and adverse events are appropriately documented and reported. The position also supports patient care coordination, communicates with treating physicians and hospital staff, and helps ensure trial activities are conducted according to protocol, institutional requirements, and applicable regulations. Minimum qualifications include a bachelor’s degree, two years of experience, and administrative or research experience. The job posting lists an hourly rate range of $34.86–$41.56. USC considers relevant experience, education, skills, and other factors when extending an offer.

Requirements

Bachelor’s degree.
Minimum two years of experience.
Administrative or research experience.
Strong medical background; prior experience as a Protocol Coordinator in clinical oncology research.
Knowledge of the medical environment and terminology.
Knowledge and understanding of federal, state, and institutional research regulations, Good Clinical Practices (GCP), and HIPPA regulations.
Proficiency with Microsoft Office applications.
Effective communication and writing skills.
Ability to multitask.
Ability to work independently with minimal supervision and as part of a team.
Ability to work effectively with many people and across different disciplines.
Completion of Human Subject Training, HIPPA, GCP, and Sexual Harassment online courses.
Completion of the Blood Bourne Pathogens online class and obtaining a shipping certificate.

Nice To Haves

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

Responsibilities

Review new protocols before committee approval for the necessity and feasibility of study tests, treatment and dose-modification considerations, and drug toxicities; provide feedback relevant to time, effort, and budget setup.
Assist with planning and staffing project operations based on proposed research activities and timelines; guide investigators, study personnel, and patients.
Communicate with study teams to support conduct of studies as written and assess protocol deviations and violations.
Participate in NCI, FDA, and pharmaceutical audits; follow applicable regulations, including Serious Adverse Event reporting requirements.
Enter Serious Adverse Events into iStar for IRB reporting and notify the Data Manager; interact with sponsoring pharmaceutical company monitors and auditors.
Enter patient registration data into the CAFE database and ensure patient therapy-response information is accurately entered at Off Treatment.
Help generate study results for investigators and provide assistance and input for publications; keep the Data Manager updated on patients’ On Study and Off Treatment/Off Study status.
Assist with training and demonstrating techniques or procedures to less experienced coordinators.
Determine patient eligibility after consent and ensure written informed consent uses the correct IRB-approved, stamped, and dated version; distribute and file consent copies as specified.
Answer patient questions about studies and toxicities; complete protocol-specific data-management forms and tools and file them in research folders.
Schedule required tests and appointments; calculate drug doses using body surface area and recalculate doses when toxicity-related modifications are needed.
Coordinate protocol follow-up, including appointments, admissions, tests, and procedures; communicate with outside physicians and obtain treatment records and laboratory results when applicable.
Ensure study toxicities are accurately recorded and report Serious Adverse Events promptly according to FDA guidelines, including within 24 hours.
Maintain investigational drug-log accuracy with the Research Pharmacist; transport drugs when required and return unused drugs within 24 hours; follow CISO procedures for oral-drug accountability.
Arrange Clinical Trials Unit admissions for required pharmacokinetic sampling; coordinate research blood draws, sample processing, storage, packing, transport, and shipment according to IATA and sponsor guidelines.
Ensure Quality of Life questionnaires are completed when appropriate and that source documents and other data needed for CRFs are obtained; complete CRFs for some studies when assigned.
Follow CISO standard operating procedures.
Discuss eligibility questions and patient concerns with physicians and investigators; serve as a liaison regarding medical problems and keep physicians informed of patient issues.
Discuss toxicities and protocol deviations or violations that may require protocol revision; ensure tumor measurements and response calculations are completed and that physicians sign Tumor Flow Sheets.
Screen potential participants on request, coordinate pre-study evaluations, determine final trial eligibility, assess psychosocial needs and baseline symptoms, and educate patients about possible toxicities and when to call for help.
Serve as the initial patient contact for problems, triage calls appropriately with the physician, assess patients for toxicity at visits, document and report adverse reactions, and ensure physician agreement and countersignature on Toxicity Assessment Forms.
Ensure drug doses are modified appropriately when necessary.
Serve as a resource for protocol questions and communicate patient problems or concerns to nurses, social workers, and home health coordinators.
Work with pharmacists and nurses to support safe and accurate administration of protocol agents; coordinate research specimens with hospital laboratories, the CTU, and destination laboratories.
Coordinate CTU admissions, complete standardized orders, obtain Principal Investigator signatures, and ensure sponsor-provided laboratory kits are delivered to the CTU.
Collaborate across clinical disciplines and clinics to recruit patients and conduct clinical trials; follow hospital regulations and guidelines and complete Research Order Forms after visits for billing.
Arrange peer coverage during illness, vacation, or meetings; contact the CISO Associate Director for assistance when coverage cannot be arranged.
Complete required training and certifications, including Human Subject Training, HIPPA, GCP, Sexual Harassment, Blood Bourne Pathogens, and shipping certification.
Perform other related duties as assigned or requested.