Experience

GE Health Care

• Germany
• IT Services and IT Consulting
• 1 - 100 Employee

• Research Program Integrator(Consultant)

  • Jul 2022 - Present

  1. Project manages defined research activity, which includes GE and Investigator Sponsored studies, evaluations, reader studies and other activities defined to meet strategic research needs. 2. Ensures that the research activities abide by all defined cross-functional standards, meets the intent and letter of Phased Review Discipline, QMS, SOPs, GCP, and all compliance and regulatory requirements of the applicable regions. 3. Assists the clinical project teams in project related… Show more 1. Project manages defined research activity, which includes GE and Investigator Sponsored studies, evaluations, reader studies and other activities defined to meet strategic research needs. 2. Ensures that the research activities abide by all defined cross-functional standards, meets the intent and letter of Phased Review Discipline, QMS, SOPs, GCP, and all compliance and regulatory requirements of the applicable regions. 3. Assists the clinical project teams in project related activities, such as creating study binders, shipping study documents 4. Leads the cross-functional research activity team and project manages the activity to conduct assigned internal and external research activity and deliver the required deliverables per the business needs and defined study plan. This includes reporting of study progress and any applicable adverse events or deviations reporting. 5. Identifies early and raises/helps solve cross-functional execution challenges which may hinder the timely completion of research commitments 6. Partners with other Research groups and the Clinical Operations team to fuel and follow operational reporting requirements, ensure effective and efficient communication, and drive execution for the duration of the project including prioritization across the assigned projects in the research portfolio. 7. Partners with the product team/internal stakeholders for prioritization and changes to study details. 8. Develops research documents as required, including protocols, plans, informed consent forms, and required storage of research documents including managing. 9. Negotiates budget and contracts with external partners and processes payments. 10. Conducts and/or coordinates required training, initiation, monitoring and closure with study site and study team. Serves as QC to support review and approval of these activities for peer studies as required. 11. Maintains applicable study records in a timely and accurate fashion which may include Clinical Trials Show less 1. Project manages defined research activity, which includes GE and Investigator Sponsored studies, evaluations, reader studies and other activities defined to meet strategic research needs. 2. Ensures that the research activities abide by all defined cross-functional standards, meets the intent and letter of Phased Review Discipline, QMS, SOPs, GCP, and all compliance and regulatory requirements of the applicable regions. 3. Assists the clinical project teams in project related… Show more 1. Project manages defined research activity, which includes GE and Investigator Sponsored studies, evaluations, reader studies and other activities defined to meet strategic research needs. 2. Ensures that the research activities abide by all defined cross-functional standards, meets the intent and letter of Phased Review Discipline, QMS, SOPs, GCP, and all compliance and regulatory requirements of the applicable regions. 3. Assists the clinical project teams in project related activities, such as creating study binders, shipping study documents 4. Leads the cross-functional research activity team and project manages the activity to conduct assigned internal and external research activity and deliver the required deliverables per the business needs and defined study plan. This includes reporting of study progress and any applicable adverse events or deviations reporting. 5. Identifies early and raises/helps solve cross-functional execution challenges which may hinder the timely completion of research commitments 6. Partners with other Research groups and the Clinical Operations team to fuel and follow operational reporting requirements, ensure effective and efficient communication, and drive execution for the duration of the project including prioritization across the assigned projects in the research portfolio. 7. Partners with the product team/internal stakeholders for prioritization and changes to study details. 8. Develops research documents as required, including protocols, plans, informed consent forms, and required storage of research documents including managing. 9. Negotiates budget and contracts with external partners and processes payments. 10. Conducts and/or coordinates required training, initiation, monitoring and closure with study site and study team. Serves as QC to support review and approval of these activities for peer studies as required. 11. Maintains applicable study records in a timely and accurate fashion which may include Clinical Trials Show less



Maryland USOncolgy and Hematology

• Clinical Research Coordinator

  • Aug 2020 - Feb 2022

  1.Responsible for screening potential patients which includes obtaining HIPAA authorization, informed consent for the study, reviewing medical records to determine eligibility, communication with the investigator and patient re: additional tests to be completed. 2. Prepare patient information for registration/randomization. 3. Notify the investigator and patient of assigned treatment and coordinate treatment start date. 4 Responsible for ordering and/or transporting study… Show more 1.Responsible for screening potential patients which includes obtaining HIPAA authorization, informed consent for the study, reviewing medical records to determine eligibility, communication with the investigator and patient re: additional tests to be completed. 2. Prepare patient information for registration/randomization. 3. Notify the investigator and patient of assigned treatment and coordinate treatment start date. 4 Responsible for ordering and/or transporting study drug, documentation of receipt and dispensing of the study drug on the Drug Accountability Record Forms (DARFs). 5. Responsible for calculating drug dosages per protocol requirements. 6. Responsible for obtaining required specimens per protocol and transport of said specimens to research office for processing and shipment. 7. Must monitor the patient throughout the active treatment phase of the study. This includes patient visits, providing investigators and clinic staff with treatment sheets/calendars of the required treatment per protocol. 8. Collaborate closely with the investigator and clinic staff in scheduling future appointments, explaining patient diaries and/or QOL questionnaires, reporting of adverse events, recognizing serious adverse events, and the need for dose modification. 2 9. Responsible for ensuring protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements. 10. Closely monitor the patient’s response to treatment. This is accomplished through communication with the investigator, tracking results of imaging scans as per RECIST guidelines as applicable and provide the investigator with information from the protocol explaining the appropriate response. 11. Inform and educate the investigator and/or clinic staff regarding study drug administration requirements, including required pre-medications, order of administration, monitoring time points, and the need for infusion start/stop times. Show less 1.Responsible for screening potential patients which includes obtaining HIPAA authorization, informed consent for the study, reviewing medical records to determine eligibility, communication with the investigator and patient re: additional tests to be completed. 2. Prepare patient information for registration/randomization. 3. Notify the investigator and patient of assigned treatment and coordinate treatment start date. 4 Responsible for ordering and/or transporting study… Show more 1.Responsible for screening potential patients which includes obtaining HIPAA authorization, informed consent for the study, reviewing medical records to determine eligibility, communication with the investigator and patient re: additional tests to be completed. 2. Prepare patient information for registration/randomization. 3. Notify the investigator and patient of assigned treatment and coordinate treatment start date. 4 Responsible for ordering and/or transporting study drug, documentation of receipt and dispensing of the study drug on the Drug Accountability Record Forms (DARFs). 5. Responsible for calculating drug dosages per protocol requirements. 6. Responsible for obtaining required specimens per protocol and transport of said specimens to research office for processing and shipment. 7. Must monitor the patient throughout the active treatment phase of the study. This includes patient visits, providing investigators and clinic staff with treatment sheets/calendars of the required treatment per protocol. 8. Collaborate closely with the investigator and clinic staff in scheduling future appointments, explaining patient diaries and/or QOL questionnaires, reporting of adverse events, recognizing serious adverse events, and the need for dose modification. 2 9. Responsible for ensuring protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements. 10. Closely monitor the patient’s response to treatment. This is accomplished through communication with the investigator, tracking results of imaging scans as per RECIST guidelines as applicable and provide the investigator with information from the protocol explaining the appropriate response. 11. Inform and educate the investigator and/or clinic staff regarding study drug administration requirements, including required pre-medications, order of administration, monitoring time points, and the need for infusion start/stop times. Show less



CBH Health, LLC.

• clinical research coordinator

  • Mar 2005 - Aug 2020

  • Oversee phase I through III clinical trials for chronically mentally ill research participants in accordance to GCP, FDA and IRB guidelines • Screen potential research participants. • Complete the informed consent process • Gather past and present medical and psychiatric history from subject, family, psychiatrist and old medical records. • Provide clinical care and perform assessments for research participants. • Collect and manage study data, including CBH generated forms… Show more • Oversee phase I through III clinical trials for chronically mentally ill research participants in accordance to GCP, FDA and IRB guidelines • Screen potential research participants. • Complete the informed consent process • Gather past and present medical and psychiatric history from subject, family, psychiatrist and old medical records. • Provide clinical care and perform assessments for research participants. • Collect and manage study data, including CBH generated forms, sponsor generated source and case report forms, study drug accountability and subject stipend records. • Ensure that the PI and sub-investigators complete necessary ratings, notes, procedures, and lab evaluations. • Monitor and discuss clinical results, medications, and any events regarding individual research participant with research team and principal investigator • Assign, label, dispense and collect investigational products. Perform study drug accountability. • Record and submit SAE to sponsor/CRO and IRB in a timely manner. • Responsible for maintaining communication between CBH Health, pharmaceutical company and other vendors involved with clinical trial • Maintain regulatory documents per FDA, Sponsor, IRB, and CBH guidelines. • Clinical research rater while with CBH Health: Health Outcome Assessments (HOA) (DS, RUD-Lite V2.4, QoL-AD, HUI), Cog State, DAD, PSP (Personal and Social Performance) as per protocol Show less • Oversee phase I through III clinical trials for chronically mentally ill research participants in accordance to GCP, FDA and IRB guidelines • Screen potential research participants. • Complete the informed consent process • Gather past and present medical and psychiatric history from subject, family, psychiatrist and old medical records. • Provide clinical care and perform assessments for research participants. • Collect and manage study data, including CBH generated forms… Show more • Oversee phase I through III clinical trials for chronically mentally ill research participants in accordance to GCP, FDA and IRB guidelines • Screen potential research participants. • Complete the informed consent process • Gather past and present medical and psychiatric history from subject, family, psychiatrist and old medical records. • Provide clinical care and perform assessments for research participants. • Collect and manage study data, including CBH generated forms, sponsor generated source and case report forms, study drug accountability and subject stipend records. • Ensure that the PI and sub-investigators complete necessary ratings, notes, procedures, and lab evaluations. • Monitor and discuss clinical results, medications, and any events regarding individual research participant with research team and principal investigator • Assign, label, dispense and collect investigational products. Perform study drug accountability. • Record and submit SAE to sponsor/CRO and IRB in a timely manner. • Responsible for maintaining communication between CBH Health, pharmaceutical company and other vendors involved with clinical trial • Maintain regulatory documents per FDA, Sponsor, IRB, and CBH guidelines. • Clinical research rater while with CBH Health: Health Outcome Assessments (HOA) (DS, RUD-Lite V2.4, QoL-AD, HUI), Cog State, DAD, PSP (Personal and Social Performance) as per protocol Show less



INSTITUTE FOR ASTHMA & ALLERGY, PC

• United States
• Medical Practices
• 1 - 100 Employee

• Clinical Research Coordinator

  • Aug 2015 - Sep 2019

  • Screened potential research participants. • Completed the informed consent process. • Collected and managed study data as required by the study protocol. • Participation in investigator meetings and academic/professional conferences. • Ensured all aspects involved in the proper conduct of a trial are in place prior to the enrollment of subjects under the direction of the research coordinator/manager. • Maintained regulatory documents per FDA, Sponsor, IRB, and company SOPs… Show more • Screened potential research participants. • Completed the informed consent process. • Collected and managed study data as required by the study protocol. • Participation in investigator meetings and academic/professional conferences. • Ensured all aspects involved in the proper conduct of a trial are in place prior to the enrollment of subjects under the direction of the research coordinator/manager. • Maintained regulatory documents per FDA, Sponsor, IRB, and company SOPs. • Coordinated the recruitment, scheduling, travel and admission of research study participants with clinical staff. • Created recruitment materials such as brochures, etc. • Created databases for tracking referrals, maintain list of referring physicians. • Contacted outside physician offices and institutions providing updated recruitment materials and information regarding available clinical trials. • Acted as a liaison between participants, participants’ relatives, and staff members; communicate participant’s questions, complaints, problems and concerns to appropriate staff members. • Created and maintain database of patient referrals and appointments using existing data. • Maintained pathology mailing log. • Created clinic schedule. • Followed up on patient appointments by sending reminder cards and placing reminder calls. • For clinical appointments, obtain all the records from patient’s physician including copies of scans. • Worked products and documents related to coordinating the recruitment, scheduling, travel and admission of research study participants with clinical staff. Worked products and documents related to acting as a liaison between participants, participants relatives, and staff members including communicating participant’s questions, complaints, problems and concerns to appropriate staff members. • Computer generated work including maintaining pathology mailing log; create and maintain database of patient screening appointments using existing data. Show less • Screened potential research participants. • Completed the informed consent process. • Collected and managed study data as required by the study protocol. • Participation in investigator meetings and academic/professional conferences. • Ensured all aspects involved in the proper conduct of a trial are in place prior to the enrollment of subjects under the direction of the research coordinator/manager. • Maintained regulatory documents per FDA, Sponsor, IRB, and company SOPs… Show more • Screened potential research participants. • Completed the informed consent process. • Collected and managed study data as required by the study protocol. • Participation in investigator meetings and academic/professional conferences. • Ensured all aspects involved in the proper conduct of a trial are in place prior to the enrollment of subjects under the direction of the research coordinator/manager. • Maintained regulatory documents per FDA, Sponsor, IRB, and company SOPs. • Coordinated the recruitment, scheduling, travel and admission of research study participants with clinical staff. • Created recruitment materials such as brochures, etc. • Created databases for tracking referrals, maintain list of referring physicians. • Contacted outside physician offices and institutions providing updated recruitment materials and information regarding available clinical trials. • Acted as a liaison between participants, participants’ relatives, and staff members; communicate participant’s questions, complaints, problems and concerns to appropriate staff members. • Created and maintain database of patient referrals and appointments using existing data. • Maintained pathology mailing log. • Created clinic schedule. • Followed up on patient appointments by sending reminder cards and placing reminder calls. • For clinical appointments, obtain all the records from patient’s physician including copies of scans. • Worked products and documents related to coordinating the recruitment, scheduling, travel and admission of research study participants with clinical staff. Worked products and documents related to acting as a liaison between participants, participants relatives, and staff members including communicating participant’s questions, complaints, problems and concerns to appropriate staff members. • Computer generated work including maintaining pathology mailing log; create and maintain database of patient screening appointments using existing data. Show less