This position requires someone who is bilingual (Korean/English) 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
Assists investigators or other staff with research studies in subject recruitment, data collection, scheduling of study-related activities and follow-up of enrolled subjects.
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.
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