ROLES AND RESPONSIBILITIES OF SITE STAFF Site Investigator 1. Oversee the operations and implementation of the trial in their respective hospital 2. Recruit patients and ensure the proper implementation of the protocol in accordance to GCP guidelines 3. Ensure informed consent is obtained from every participating patient 4. Comply with data privacy, patient confidentiality and all other applicable requirements in the conduct of the clinical trial 5. Comply with safety reporting guidelines including reporting timelines 6. Responsible for obtaining institutional REC approval of the study in their respective hospital 7. Ensure proper documentation as required by the trial 8. Submit reports, protocol amendments, SUSAR and other required reports Co-Investigator (if any) 1. Execution of the clinical trial (helping in informed consent process, collecting samples for monitored laboratory tests) 2. Prepare data reports, technical specifications for needed supplies and other reports related to project completion 3. Assure acquisition of drugs and study materials in. the participating hospitals; maintain availability of trial materials, and keep inventory and tracking of supplies 4. Work closely with study site investigator and other members of the trial team 5. Assist study site investigator to administer medications to patients of the trial 6. Ensure the proper procedure and practice required of the protocol 7. Ensure patient confidentiality and data privacy is adhered to by all members of the trial team in their respective hospitals 8. Comply with safety reporting guidelines including reporting timelines 9. Ensure proper documentation as required by the trial 10. In-charge of monitoring and tracking of trial funds in their respective hospital Trial Physician 1. Oversee the operations and implementation of the trial in their respective hospital 2. Responsible for trial procedures such as: a. Recruitment b. Biometric/ ID Registration c. Randomization d. Vaccine administration e. Initial assessment for possible adverse events f. Assessment during follow-up 3. Oversee patient recruitment, informed consent, follow-up a. Provide general orientation regarding the vaccine trial b. Recruit patients and ensure the proper implementation of protocol in accordance with GCP guidelines c. Ensure informed consent is obtained from every participating patient d. Comply data privacy, patient confidentiality and all other applicable requirements in the conduct of a clinical trial e. Fully inform the subject of the nature and scope of the study, potential risks and benefits, and the study procedures and will answer all questions prior to requesting the subject’s signature on the ICF. Review and proceed with the signature of the ICF. 4. 5. 6. 7. 8. f. Collect and review demographics, medical history g. Perform a vital sign measurement: BP, HR, VS, body measurement (weight and height) h. Perform history- or symptom-based physical examination i. Review the inclusion and exclusion criteria and determine the subject’s eligibility to participate in this study. j. Collect urine sample for female subjects of childbearing potential and perform a urine dipstick pregnancy test. k. Provide appointments for the next visit and distribute post vaccination diary. l. Register the subject in the interactive web response system for randomization In charge of the in-site operations for the trial team Assure acquisition of vaccine and study materials in the participating hospitals; maintain availability of trial materials and keep inventory and tracking of supplies Comply to safety reporting guidelines including reporting timelines Responsible to obtain institutional REC approval of the study in their respective hospital Ensure proper documentation as required by the trial Trial Nurse 1. Responsible for trial procedures a. Recruitment b. Biometric/ ID Registration c. Registration of trial participants d. Nasopharyngeal swab e. Venipuncture (for IV Therapy Nurse) f. Vaccine Administration 2. Perform patient recruitment, informed consent, follow-up a. Recruit patients and ensure the proper implementation of protocol in accordance to GCP guidelines b. Fully inform the subject of the nature and scope of the study, potential risks and benefits, and the study procedures c. Perform a vital sign measurement: BP, HR, VS, body measurement (weight and height) d. Collect urine sample for female subjects of childbearing potential and perform a urine dipstick pregnancy test. e. Provide appointments for the next visit and distribute post vaccination diary. f. Schedule telephone contact for follow up g. Conduct active and passive follow up phone call 2. Assure acquisition of vaccine and study materials in the participating hospitals; maintain availability of trial materials and keep inventory and tracking of supplies 3. Maintain forms related to patient recruitment, informed consent, follow-up 3. In charge of non-laboratory equipment and forms on site Pharmacist 1. Ensure proper receipt and dispensing of study drugs/vaccines 2. Complete drug/vaccine accountability forms 3. Ensure supply of study drugs/vaccines in the site Trial Medical Technologist 1. Responsible for trial procedures such as: a. Venipuncture 2. 3. 4. 5. 6. 7. 8. b. Nasopharyngeal swab c. Biometric/ ID Registration Perform patient recruitment a. Collect urine sample for female subjects of childbearing potential and perform a urine dipstick pregnancy test. Processing of samples, proper storage of specimens and shipping, preferably with IATA certification Maintain forms related to laboratory procedures Maintain forms related to patient recruitment, informed consent, follow-up Maintain an inventory of study equipment In charge of laboratory equipment and forms on site Daily temperature monitoring of study refrigerator where samples are stored until shipment Research Assistant 1. Encoding trial data 2. Ensure accurate and timely clinical research data is entered in appropriate fields in the database 3. Checks with site staff that patient confidentiality and data privacy is maintained. 4. Process data needed and ensure data safety and confidentiality 5. Prepare trial hospital summaries and other site trial reports as required 6. Checks compliance in the implementation of proper procedure and practice required of the protocol 7. Responsible for trial procedures with the supervision of the Site Investigator a. Recruitment b. Registration of trial participants c. Biometric/ ID Registration 8. Assist in patient recruitment, informed consent (if with training), follow-up a. Execution of clinical trial: Transfers blood specimen from study site to laboratory, transfers study vaccine from study site to laboratory b. Assist study site investigator to administer vaccine to patients of trial c. Provide appointments for the next visit and distribute post vaccination diary. d. Schedule telephone contact for follow up e. Conduct active and passive follow up phone call 9. Coordinates the acquisition of vaccine and study materials in the participating hospitals; maintain availability of trial materials and keep inventory and tracking of supplies 10. Prepare data reports, technical specifications for needed supplies and other reports related to project completion 11. Complies to safety reporting guidelines including reporting timelines 12. Ensure proper documentation and record keeping as required by the trial 13. Work closely with study site investigator and other members of the trial tea 1. 2. 3. 4. 5. Administrative Assistant project completion Ensure accurate and timely clinical research data is entered in appropriate fields in the database Process data needed and ensure data safety and confidentiality Prepare trial hospital summaries and other site t 6. Encoding trial data 7. Preparing reports related torial reports as require 8. Monitors and tracks trial funds in their respective sites Commented [1]: (IATA certification specific to the person in-charge of sample shipment) Commented [2]: …were samples are stored until shipment. Commented [3]: How is this different from item #2 Commented [4]: Perhaps better if….”Checks compliance in the implementation of prcoedures…..” Commented [5]: ….with supervision of the PI. Commented [6]: Coordinates on acquisition…..
