This position requires a person with a strong medical background and an interest in clinical research. The role of the Research Coordinator I is a diverse one. This person works independently, yet is able to relate well with physicians, patients, peers, data managers, and other hospital personnel. The Coordinator is accountable to the Medical Director and Associate Director of CISO and to the Principal Investigators with whom he/she works. This person is familiar with and adheres to the policies and procedures of the hospital where working. The Coordinatorâs functions include but are not restricted to those listed below.Â Â Â Â Â
Specific Job Functions
A. Protocol Related
1. On request from supervisor, reviews in-house protocols prior to CIC approval, looking specifically at necessity and feasibility of required study tests, at areas pertaining to patient compliance, dose modification and at drug toxicities. At times will provide information regarding time or effort to facilitate budget set up. 2. Ensures that study is conducted as written so that scientific questions are answered. 3. Conducts ongoing assessment of protocol deviations and violations. 4. Participates in NCI, FDA and pharmaceutical audits and is knowledgeable of their regulations, especially concerning the reporting of Serious Adverse Events. Enters SAE into iStar for reporting to the IRB. Notifies Data Managers promptly of occurrence of SAE. 5. Interacts with the monitors/auditors from the sponsoring pharmaceutical companies.
B. Protocol Administration 1. Determines patient eligibility Â Â Â a. Schedules necessary tests. Â Â Â b. Ensures that written informed consent is obtained using correct version of the stamped Informed Â Â Â Consent. Answers patientâs questions regarding study and toxicities. Â Â Â c. Calculates correct dose of drug to be administered after determining the Body Surface Area (BSA). Â Â Â Subsequent dose modifications based on toxicity may be necessary and require recalculation. Â
2. Protocol Compliance a. Ensures correct date for return clinic appointment or hospital admission. b. Schedules or ensures that required tests and procedures for follow-up are done. c. If patient being seen at outside facility, corresponds with outside physician to ensure that protocol is followed and that tests and procedures are performed. Obtains treatment records from hospital or physician and obtains outside laboratory results. d. Ensures that study toxicities are recorded correctly and accurately. If Serious Adverse Events are experienced, follows FDA guidelines for prompt reporting within 24 hours.
e. If requested will also do data management, ie, CRF completion on certain protocols and patients.
f. Follows CISO SOPs
II. Patient Care Related
A. Physician/Investigator Interaction
1. Discusses patient eligibility questions and any patient concerns.
2. Is liaison between patient and physician in dealing with medical problems.
3. Notifies physician of Serious Adverse Event.Â Keep physician updated on patient problems.
4. Discusses toxicities, protocol deviations, or violations that may require a protocol revision.
5. Ensures that tumor measurements are obtained and calculates responses. Ensures that physician signs the Tumor Flow Sheet
6. Generates data for ongoing evaluation of study when requested.
B. Patient Interaction
1. On request, screens for potential protocol patients.
2. Coordinates pre-study evaluations and determines final eligibility to trial.
3. Follow ups with patients for any potential questions regarding the study and toxicities.
4. Assesses psychosocial needs to ensure patient compliance.
5. Conducts thorough pre-study assessment for determining baseline symptoms for Toxicity Assessment form.
6. Educates patient regarding possible toxicities and instructs patient to call if any questions or problems.Â Is the initial contact person for the patient for problems encountered. Will triage calls appropriately with the physician.
7. Sees patient at each visit for ongoing toxicity assessment; assesses, documents, and reports adverse reactions and ensures that treating physician countersigns the Toxicity Assessment Form. If necessary, ensures that the drug dose is modified appropriately.
8. Performs other related duties as assigned or requested.
Preferred Education: Bachelorâs Degree.Â Combined experience/education as substitute for minimum education.
Preferred Experience: 2 years
Preferred Field of Expertise: Knowledge of medical environment and terminology.
Applicant Attachments (Optional): Letters of reference
The University of Southern California strongly values diversity and is committed to equal opportunity in employment.Â Women and men, and members of all racial and ethnic groups, people with disabilities, and veterans are encouraged to apply.
The hourly rate range for this position is $29.98 - $35.75. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidateâs work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational consideration.
Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum educationMinimum Experience: 1 yearMinimum Field of Expertise: Administrative or research experience. Working knowledge of MS Office applications. Demonstrated effective communication and writing skills. Ability to multi-task and prioritize. Demonstrated ability to work as part of a team as well as independently.
USC is the leading private research university in Los Angeles—a global center for arts, technology and international business. With more than 47,500 students, we are located primarily in Los Angeles but also in various US and global satellite locations.
As the largest private employer in Los Angeles, responsible for $8 billion annually in economic activity in the region, we offer the opportunity to work in a dynamic and diverse environment, in careers that span a broad spectrum of talents and skills across a variety of academic and professional schools and administrative units. As a USC employee and member of the Trojan Family—the faculty, staff, students, and alumni who make USC a great place to work—you will enjoy excellent benefits, including a variety of well-being programs designed to help individuals achieve work-life balance.