Ian Kelleher
Clinical Research Associate at Sarah Cannon- Claim this Profile
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Bio
Credentials
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15 Secrets Successful People Know about Time Management (getAbstract Summary)
LinkedInMay, 2023- Sep, 2024 -
How to Set Goals When Everything Feels Like a Priority
LinkedInAug, 2022- Sep, 2024
Experience
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Sarah Cannon
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United States
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Research Services
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300 - 400 Employee
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Clinical Research Associate
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Nov 2020 - Present
•Serve as the primary point of contact for investigational sites. •Perform Pre-Study Visits (PSVs), Site Initiation Visits (SIVs), Routine Monitoring Visits (RMVs), and Close- Out Visits (COVs) in accordance with ICH/GCP, study-specific requirements, monitoring plans (MPs), company SOPs, applicable regulatory requirements and defined quality and performance standards. •Review Case Report Forms (CRFs) and source documents to conduct source data verification (SDV) according to the MP… Show more •Serve as the primary point of contact for investigational sites. •Perform Pre-Study Visits (PSVs), Site Initiation Visits (SIVs), Routine Monitoring Visits (RMVs), and Close- Out Visits (COVs) in accordance with ICH/GCP, study-specific requirements, monitoring plans (MPs), company SOPs, applicable regulatory requirements and defined quality and performance standards. •Review Case Report Forms (CRFs) and source documents to conduct source data verification (SDV) according to the MP, protocol, ICH/GCP and region specific regulations. •Ensure inspection readiness by collecting and reviewing documents in the investigator site file (ISF) and submitting them to the Trial Master File (TMF). •Conduct investigational product accountability to ensure accuracy, proper storage, dispensation and reconciliation. •Update Clinical Trial Management System (CTMS) as required by CTMS user manual and project specific requirements. •Ensure site Institutional Review Board (IRB) approval is current and all IRB documentation is complete and accurate. •Demonstrates good knowledge of SOPs as well as technical systems (ie, CTMS, Electronic Data Capture [EDC], eTMF, central lab vendor system, etc.) as they relate to the project. •Ensure patient informed consent procedures at the site are executed and documented according to ICH/GCP and region specific regulatory requirements. •Maintain accurate and complete records for assigned sites including tracking of subject status, subject CRF review and verification, source document review, regulatory document review and collection, and investigational product accountability. •Accountable for attending study meetings and conducting follow-up on required action items assigned by the study team. •60%- 80% travel, including overnight stays, is required and may involve travel to meetings or attendance at conferences. In addition, weekend and evening travel and meeting attendance may be required depending upon the workload and nature of current programs.
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Clinical Research Coordinator
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Jul 2018 - Nov 2020
• Coordination of Phase I-IV Oncology Trials • Review protocol to ensure a knowledge base is built about the study and what procedures it entails. • Work with clinic scheduler to ensure patients are scheduled for Study Office Visits according to protocol Schedule of Assessments. • Ensure that Office Visits, lab orders, and research procedures are input accordingly into ONCO EMR, follow-up with nurse to add additional labs/procedures necessary per the protocol. • Pre-Screen patients… Show more • Coordination of Phase I-IV Oncology Trials • Review protocol to ensure a knowledge base is built about the study and what procedures it entails. • Work with clinic scheduler to ensure patients are scheduled for Study Office Visits according to protocol Schedule of Assessments. • Ensure that Office Visits, lab orders, and research procedures are input accordingly into ONCO EMR, follow-up with nurse to add additional labs/procedures necessary per the protocol. • Pre-Screen patients to determine eligibility of enrollment for clinical trials. Follow-up with patient if determined eligible and assess interest in the study. • Coordinate Informed Consent meetings between the patient and one of our physicians if eligibility and interest is met by the patient. • Attend Informed Consent Meetings with investigator and patient to provide any additional protocol specific information that the patient may need before signing consent. • Work with Research Nurse to ensure that they are informed of the Research Subject Visit and provide them with all documentation, lab materials, and medication needed for the visit. • Ensure correct source documentation is collected, acknowledged, and assessed by treating physician. • Complete patient study binder with necessary source documents. • Internal Monitoring of all CRFs in the EDC, Regulatory Documents, Informed Consents, Protocol Deviations, INDSRs, SAEs, IRB Approvals, Essential Documents, Credentials, Enrollments Logs, etc. • Input data into EDC for the patients enrolled on assigned trials, and address queries as they are generated to ensure data is clean and that EDC Data Input is met per sponsor guidelines. • Update Study Trackers, Patient Trackers, and Visit Trackers for the studies assigned to me. • Maintain excellent working knowledge of all assigned study protocols, ICH and GCP guidelines • Back-up Regulatory Affairs Specialist for Colorado Blood Cancer Institute.
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Syneos Health
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United States
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Biotechnology Research
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700 & Above Employee
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Clinical Research Coordinator
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Nov 2017 - Jul 2018
• Coordination of Phase I-IV Oncology Trials • Review protocol to ensure a knowledge base is built about the study and what procedures it entails. • Work with clinic scheduler to ensure patients are scheduled for Study Office Visits according to protocol Schedule of Assessments. • Ensure that Office Visits, lab orders, and research procedures are input accordingly into ONCO EMR, follow-up with nurse to add additional labs/procedures necessary per the protocol. • Pre-Screen patients… Show more • Coordination of Phase I-IV Oncology Trials • Review protocol to ensure a knowledge base is built about the study and what procedures it entails. • Work with clinic scheduler to ensure patients are scheduled for Study Office Visits according to protocol Schedule of Assessments. • Ensure that Office Visits, lab orders, and research procedures are input accordingly into ONCO EMR, follow-up with nurse to add additional labs/procedures necessary per the protocol. • Pre-Screen patients to determine eligibility of enrollment for clinical trials. Follow-up with patient if determined eligible and assess interest in the study. • Coordinate Informed Consent meetings between the patient and one of our physicians if eligibility and interest is met by the patient. • Attend Informed Consent Meetings with investigator and patient to provide any additional protocol specific information that the patient may need before signing consent. • Work with Research Nurse to ensure that they are informed of the Research Subject Visit and provide them with all documentation, lab materials, and medication needed for the visit. • Ensure correct source documentation is collected, acknowledged, and assessed by treating physician. • Complete patient study binder with necessary source documents. • Internal Monitoring of all CRFs in the EDC, Regulatory Documents, Informed Consents, Protocol Deviations, INDSRs, SAEs, IRB Approvals, Essential Documents, Credentials, Enrollments Logs, etc. • Input data into EDC for the patients enrolled on assigned trials, and address queries as they are generated to ensure data is clean and that EDC Data Input is met per sponsor guidelines. • Update Study Trackers, Patient Trackers, and Visit Trackers for the studies assigned to me. • Maintain excellent working knowledge of all assigned study protocols, ICH and GCP guidelines • Back-up Regulatory Affairs Specialist for Colorado Blood Cancer Institute. Show less • Coordination of Phase I-IV Oncology Trials • Review protocol to ensure a knowledge base is built about the study and what procedures it entails. • Work with clinic scheduler to ensure patients are scheduled for Study Office Visits according to protocol Schedule of Assessments. • Ensure that Office Visits, lab orders, and research procedures are input accordingly into ONCO EMR, follow-up with nurse to add additional labs/procedures necessary per the protocol. • Pre-Screen patients… Show more • Coordination of Phase I-IV Oncology Trials • Review protocol to ensure a knowledge base is built about the study and what procedures it entails. • Work with clinic scheduler to ensure patients are scheduled for Study Office Visits according to protocol Schedule of Assessments. • Ensure that Office Visits, lab orders, and research procedures are input accordingly into ONCO EMR, follow-up with nurse to add additional labs/procedures necessary per the protocol. • Pre-Screen patients to determine eligibility of enrollment for clinical trials. Follow-up with patient if determined eligible and assess interest in the study. • Coordinate Informed Consent meetings between the patient and one of our physicians if eligibility and interest is met by the patient. • Attend Informed Consent Meetings with investigator and patient to provide any additional protocol specific information that the patient may need before signing consent. • Work with Research Nurse to ensure that they are informed of the Research Subject Visit and provide them with all documentation, lab materials, and medication needed for the visit. • Ensure correct source documentation is collected, acknowledged, and assessed by treating physician. • Complete patient study binder with necessary source documents. • Internal Monitoring of all CRFs in the EDC, Regulatory Documents, Informed Consents, Protocol Deviations, INDSRs, SAEs, IRB Approvals, Essential Documents, Credentials, Enrollments Logs, etc. • Input data into EDC for the patients enrolled on assigned trials, and address queries as they are generated to ensure data is clean and that EDC Data Input is met per sponsor guidelines. • Update Study Trackers, Patient Trackers, and Visit Trackers for the studies assigned to me. • Maintain excellent working knowledge of all assigned study protocols, ICH and GCP guidelines • Back-up Regulatory Affairs Specialist for Colorado Blood Cancer Institute. Show less
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Pharmatech
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United States
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Pharmaceutical Manufacturing
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Project Associate
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Aug 2016 - Oct 2017
• Compose and distribute Investigator Site Regulatory Binders, updated Regulatory Documents, Selection/Decline Letters, Acknowledgement of Receipts, and Cover Letters to sites. • Submit (electronic and hard copy) documents to Trial Master File and ensure Trial Master File Metrics remain up to date. Follow-up with sites personally to obtain documents currently outstanding in the Trial Master File. • Run, review, and analyze Study Reports for accuracy and work with the study team to ensure… Show more • Compose and distribute Investigator Site Regulatory Binders, updated Regulatory Documents, Selection/Decline Letters, Acknowledgement of Receipts, and Cover Letters to sites. • Submit (electronic and hard copy) documents to Trial Master File and ensure Trial Master File Metrics remain up to date. Follow-up with sites personally to obtain documents currently outstanding in the Trial Master File. • Run, review, and analyze Study Reports for accuracy and work with the study team to ensure updates are completed correctly. • Track documents, shipments, Investigational Product, and supplies sent to site. Ensure that site has been sent the product and that they have also received them. • Internal Monitoring of all CRFs in the EDC, Regulatory Documents, Informed Consents, Protocol Deviations, INDSRs, SAEs, IRB Approvals, Essential Documents, Credentials, Enrollments Logs, etc. • Update the Master Data Hub and Study Team Roster for all changes to the site staff and study team. • Ensure that site staff training is up to date. Follow-up to provide access/login credentials to staff joining the study. • Resolve EDC queries and work with sites personally to ensure they are up to date with their Data Entry. • Ensure patient compliance remains high. Follow-up with site to ensure no adverse events have been had by patient during a period of non-compliance. • Update Central Laboratories when additional lab supplies are needed by the sites. • Submit and retrieve documents to IRB. Experienced in working with Schulman, WIRB, and CIRB Show less • Compose and distribute Investigator Site Regulatory Binders, updated Regulatory Documents, Selection/Decline Letters, Acknowledgement of Receipts, and Cover Letters to sites. • Submit (electronic and hard copy) documents to Trial Master File and ensure Trial Master File Metrics remain up to date. Follow-up with sites personally to obtain documents currently outstanding in the Trial Master File. • Run, review, and analyze Study Reports for accuracy and work with the study team to ensure… Show more • Compose and distribute Investigator Site Regulatory Binders, updated Regulatory Documents, Selection/Decline Letters, Acknowledgement of Receipts, and Cover Letters to sites. • Submit (electronic and hard copy) documents to Trial Master File and ensure Trial Master File Metrics remain up to date. Follow-up with sites personally to obtain documents currently outstanding in the Trial Master File. • Run, review, and analyze Study Reports for accuracy and work with the study team to ensure updates are completed correctly. • Track documents, shipments, Investigational Product, and supplies sent to site. Ensure that site has been sent the product and that they have also received them. • Internal Monitoring of all CRFs in the EDC, Regulatory Documents, Informed Consents, Protocol Deviations, INDSRs, SAEs, IRB Approvals, Essential Documents, Credentials, Enrollments Logs, etc. • Update the Master Data Hub and Study Team Roster for all changes to the site staff and study team. • Ensure that site staff training is up to date. Follow-up to provide access/login credentials to staff joining the study. • Resolve EDC queries and work with sites personally to ensure they are up to date with their Data Entry. • Ensure patient compliance remains high. Follow-up with site to ensure no adverse events have been had by patient during a period of non-compliance. • Update Central Laboratories when additional lab supplies are needed by the sites. • Submit and retrieve documents to IRB. Experienced in working with Schulman, WIRB, and CIRB Show less
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ICON plc
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Ireland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Clinical Trial Associate
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May 2015 - Aug 2016
• Compose and distribute Investigator Site Regulatory Binders, updated Regulatory Documents, Selection/Decline Letters, Acknowledgement of Receipts, and Cover Letters to sites. • Submit (electronic and hard copy) documents to Trial Master File and ensure Trial Master File Metrics remain up to date. Follow-up with sites personally to obtain documents currently outstanding in the Trial Master File. • Run, review, and analyze Study Reports for accuracy and work with the study team to ensure… Show more • Compose and distribute Investigator Site Regulatory Binders, updated Regulatory Documents, Selection/Decline Letters, Acknowledgement of Receipts, and Cover Letters to sites. • Submit (electronic and hard copy) documents to Trial Master File and ensure Trial Master File Metrics remain up to date. Follow-up with sites personally to obtain documents currently outstanding in the Trial Master File. • Run, review, and analyze Study Reports for accuracy and work with the study team to ensure updates are completed correctly. • Track documents, shipments, Investigational Product, and supplies sent to site. Ensure that site has been sent the product and that they have also received them. • Internal Monitoring of all CRFs in the EDC, Regulatory Documents, Informed Consents, Protocol Deviations, INDSRs, SAEs, IRB Approvals, Essential Documents, Credentials, Enrollments Logs, etc. • Work with multiple countries in LATAM, EU, and APAC to ensure overall study procedures and tasks are being accomplished. • Update the Master Data Hub and Study Team Roster for all changes to the site staff and study team. • Ensure that site staff training is up to date. Follow-up to provide access/login credentials to staff joining the study. • Ensure patient compliance remains high. Follow-up with site to ensure no adverse events have been had by patient during a period of non-compliance. • Update Central Laboratories when additional lab supplies are needed by the sites. • Submit and retrieve documents to IRB. Experienced in working with Schulman, WIRB, and CGIRB • Mentor to selected new employees also working on specific studies. Show less • Compose and distribute Investigator Site Regulatory Binders, updated Regulatory Documents, Selection/Decline Letters, Acknowledgement of Receipts, and Cover Letters to sites. • Submit (electronic and hard copy) documents to Trial Master File and ensure Trial Master File Metrics remain up to date. Follow-up with sites personally to obtain documents currently outstanding in the Trial Master File. • Run, review, and analyze Study Reports for accuracy and work with the study team to ensure… Show more • Compose and distribute Investigator Site Regulatory Binders, updated Regulatory Documents, Selection/Decline Letters, Acknowledgement of Receipts, and Cover Letters to sites. • Submit (electronic and hard copy) documents to Trial Master File and ensure Trial Master File Metrics remain up to date. Follow-up with sites personally to obtain documents currently outstanding in the Trial Master File. • Run, review, and analyze Study Reports for accuracy and work with the study team to ensure updates are completed correctly. • Track documents, shipments, Investigational Product, and supplies sent to site. Ensure that site has been sent the product and that they have also received them. • Internal Monitoring of all CRFs in the EDC, Regulatory Documents, Informed Consents, Protocol Deviations, INDSRs, SAEs, IRB Approvals, Essential Documents, Credentials, Enrollments Logs, etc. • Work with multiple countries in LATAM, EU, and APAC to ensure overall study procedures and tasks are being accomplished. • Update the Master Data Hub and Study Team Roster for all changes to the site staff and study team. • Ensure that site staff training is up to date. Follow-up to provide access/login credentials to staff joining the study. • Ensure patient compliance remains high. Follow-up with site to ensure no adverse events have been had by patient during a period of non-compliance. • Update Central Laboratories when additional lab supplies are needed by the sites. • Submit and retrieve documents to IRB. Experienced in working with Schulman, WIRB, and CGIRB • Mentor to selected new employees also working on specific studies. Show less
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Education
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2010 - 2014
North Carolina State University
Bachelor of Science - BS, Human Biology -
2006 - 2010
Northwest Guilford High School
Undergraduate, General Studies
Community
