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Research Coordinator I
University of Southern California • Los Angeles, CA 90006 • Posted 3 days ago
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In-person • Full-time • $30.62-$35.56/hr • Entry Level
Job Highlights
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The Research Coordinator I at the University of Southern California's Keck School of Medicine is a key role responsible for coordinating clinical research activities. This position involves working independently while interacting with physicians, patients, peers, data managers, and other hospital personnel. The coordinator is accountable to the Medical Director and Associate Director of CISO, as well as the Principal Investigators, and is expected to adhere to hospital policies and procedures. Responsibilities include protocol review, ensuring study compliance, patient care coordination, and data management.
Responsibilities
- Reviews in-house protocols prior to CIC approval, focusing on study tests, patient compliance, dose modification, and drug toxicities.
- Ensures study is conducted as written to answer scientific questions.
- Conducts ongoing assessment of protocol deviations and violations.
- Participates in NCI, FDA, and pharmaceutical audits, adhering to their regulations.
- Interacts with monitors/auditors from sponsoring pharmaceutical companies.
- Determines patient eligibility, schedules necessary tests, and ensures informed consent.
- Ensures correct date for return clinic appointment or hospital admission.
- Schedules or ensures required tests and procedures for follow-up.
- Corresponds with outside physician to ensure protocol is followed.
- Ensures that study toxicities are recorded correctly and reports Serious Adverse Events.
- Follows CISO SOPs and discusses patient eligibility questions and concerns.
- Discusses toxicities, protocol deviations, or violations that may require a protocol revision.
- Generates data for ongoing evaluation of study when requested.
- Screens for potential protocol patients and coordinates pre-study evaluations.
- Follows up with patients for questions regarding the study and toxicities.
- Assesses psychosocial needs to ensure patient compliance.
- Educates patient regarding possible toxicities and is the initial contact for problems.
Qualifications
Required
- Bachelor's degree or equivalent combination of education and experience.
- 1 year of experience in administrative or research.
- 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 and independently.
Preferred
- 2 years of experience.
- Knowledge of medical environment and terminology.
About University of Southern California
The University of Southern California (USC) is a prestigious private research university in Los Angeles, offering a wide range of undergraduate and graduate programs in various disciplines such as arts, sciences, business, engineering, law, and healthcare. Known for its esteemed faculties and strong ties to the entertainment industry, USC boasts a global presence with partnerships and affiliations worldwide, providing students with academic collaborations and research opportunities. The university prioritizes diversity, inclusion, and access to education, continuously investing in research capabilities and infrastructure to maintain its reputation as a leading research institution.
Full Job Description
Research Coordinator IApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA---Health-Sciences-Campus/Research-Coordinator-I\_REQ20154990/apply) Keck School of Medicine Los Angeles, California
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 Coordinator's functions include but are not restricted to those listed below.
Specific Job Functions
I. Research
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
a. Schedules necessary tests.
b. Ensures that written informed consent is obtained using correct version of the stamped Informed Consent. Answers patient's questions regarding study and toxicities.
c. Calculates correct dose of drug to be administered after determining the Body Surface Area (BSA). Subsequent dose modifications based on toxicity may be necessary and require recalculation.
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. 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. 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 Qualifications
+ Preferred Education: Bachelor's Degree. Combined experience/education as substitute for minimum education.
+ Preferred Experience: 2 years
+ Supervises: N/A
+ Supervises- Nature of Work:
+ Preferred Field of Expertise: Knowledge of medical environment and terminology.
Special Instructions to Applicants
+ Applicant Attachments (Required): Cover Letter and Résumé
+ Applicant Attachments (Optional): Letters of reference
The hourly rate range for this position is $30.62 - $35.56. 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 candidate's 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.
The University of Southern California strongly values diversity and is committed to equal opportunity in employment. Women and men, and members of all racial and ethnic groups, people with disabilities, and veterans are encouraged to apply.
Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education Minimum Experience: 1 year Minimum 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.
REQ20154990 Posted Date: 09/15/2024
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 Coordinator's functions include but are not restricted to those listed below.
Specific Job Functions
I. Research
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
a. Schedules necessary tests.
b. Ensures that written informed consent is obtained using correct version of the stamped Informed Consent. Answers patient's questions regarding study and toxicities.
c. Calculates correct dose of drug to be administered after determining the Body Surface Area (BSA). Subsequent dose modifications based on toxicity may be necessary and require recalculation.
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. 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. 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 Qualifications
+ Preferred Education: Bachelor's Degree. Combined experience/education as substitute for minimum education.
+ Preferred Experience: 2 years
+ Supervises: N/A
+ Supervises- Nature of Work:
+ Preferred Field of Expertise: Knowledge of medical environment and terminology.
Special Instructions to Applicants
+ Applicant Attachments (Required): Cover Letter and Résumé
+ Applicant Attachments (Optional): Letters of reference
The hourly rate range for this position is $30.62 - $35.56. 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 candidate's 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.
The University of Southern California strongly values diversity and is committed to equal opportunity in employment. Women and men, and members of all racial and ethnic groups, people with disabilities, and veterans are encouraged to apply.
Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education Minimum Experience: 1 year Minimum 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.
REQ20154990 Posted Date: 09/15/2024
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