Lead Clinical Research Associate working on the ECHO Program. The Duke Clinical Research Institute (DCRI) has been named the coordinating center for the ECHO Program as part of a $157-million federal initiative involved in studying how environmental factors affect childhood health.

Provide site management for observational research study sites in accordance with relevant SOPs, study specific procedures and regulations. Responsibility for protocol expertise with accountability for quality and timelines and the following site start-up activities:• Site identification• Negotiation of site agreements and budgets• Collection and review of regulatory documents for EC and RA submissions• Customization of informed consent• Remote and On Site… Show more Provide site management for observational research study sites in accordance with relevant SOPs, study specific procedures and regulations. Responsibility for protocol expertise with accountability for quality and timelines and the following site start-up activities:• Site identification• Negotiation of site agreements and budgets• Collection and review of regulatory documents for EC and RA submissions• Customization of informed consent• Remote and On Site managementAdditional responsibilities include review of eDC data. The ORS is accountable for site satisfaction and issue resolution or appropriate issue escalation. Currently acting as the Observational Research Lead for specific studies. Liaise directly with the sponsor to update them on the progress of the project. Conduct and facilitate specific start up activities, such as site identification, perform remote Qualification Visits, feasibilities, site selection activities, SRP collection and review and approval of essential study start up and amendment documents, ICF customization and approval, Ethic Committee and Regulatory Authority submissions, as well as coordinates SSU activities on small size studies. Extensive experience in preparation and negotiation of Clinical Site Agreements (CSAs) on a site level and acts as the main Contact on individual projects. Knowledgeable of ICH Guidelines, GCPs, local Regulatory Agency requirements and PAREXEL SOPs.Assisted in the development of the Observational Research Group SOPs. Designed several Observational Research document templates. Extensively trained to use all systems of the Citeline Clinical Trial database. Show less

Provide site management for observational research study sites in accordance with relevant SOPs, study specific procedures and regulations. Responsibility for protocol expertise with accountability for quality and timelines and the following site start-up activities:• Site identification• Negotiation of site agreements and budgets• Collection and review of regulatory documents for EC and RA submissions• Customization of informed consent• Remote and On Site… Show more Provide site management for observational research study sites in accordance with relevant SOPs, study specific procedures and regulations. Responsibility for protocol expertise with accountability for quality and timelines and the following site start-up activities:• Site identification• Negotiation of site agreements and budgets• Collection and review of regulatory documents for EC and RA submissions• Customization of informed consent• Remote and On Site managementAdditional responsibilities include review of eDC data. The ORS is accountable for site satisfaction and issue resolution or appropriate issue escalation. Currently acting as the Observational Research Lead for specific studies. Liaise directly with the sponsor to update them on the progress of the project. Conduct and facilitate specific start up activities, such as site identification, perform remote Qualification Visits, feasibilities, site selection activities, SRP collection and review and approval of essential study start up and amendment documents, ICF customization and approval, Ethic Committee and Regulatory Authority submissions, as well as coordinates SSU activities on small size studies. Extensive experience in preparation and negotiation of Clinical Site Agreements (CSAs) on a site level and acts as the main Contact on individual projects. Knowledgeable of ICH Guidelines, GCPs, local Regulatory Agency requirements and PAREXEL SOPs.Assisted in the development of the Observational Research Group SOPs. Designed several Observational Research document templates. Extensively trained to use all systems of the Citeline Clinical Trial database. Site Start Up Subject Matter Expert (SME). As a Site Start Up SME, I was part of the help desk team and coached colleagues on the system's uses and functions.Conducted the User Acceptance Testing (UAT) for the sponsor's EDC system to help determine that the specifications and requirements of the system were met and adhered to the protocol. Show less

Conduct and facilitate specific start up activities, such as site identification, perform remote Qualification Visits, feasibilities, site selection activities, SRP collection and review and approval of essential study start up and amendment documents, ICF customization and approval, Ethic Committee and Regulatory Authority submissions, as well as coordinates SSU activities on small size studies. Experience in preparation and negotiation of Clinical Site Agreements (CSAs) on a site level and… Show more Conduct and facilitate specific start up activities, such as site identification, perform remote Qualification Visits, feasibilities, site selection activities, SRP collection and review and approval of essential study start up and amendment documents, ICF customization and approval, Ethic Committee and Regulatory Authority submissions, as well as coordinates SSU activities on small size studies. Experience in preparation and negotiation of Clinical Site Agreements (CSAs) on a site level and acts as the main CTS Contact on individual projects. Knowledgeable of ICH Guidelines, GCPs, local Regulatory Agency requirements and PAREXEL SOPs.Kaizen SRP Specialist Subject Matter Expert (SME) Show less

Participated in Phase Phase Il - IV Clinical studiesCoordinating on over seventy clinical research trials following the guidelines set forth by the FDAManaged and supervised other coordinators. Established a Standard Operating Procedures manualDesigned a spreadsheet that tracks every study and status of each subject in the trialNegotiating budgets for each new study.Maintain regulatory documentationTraining all new Clinical Research Coordinators in SOP, GCP and ICH… Show more Participated in Phase Phase Il - IV Clinical studiesCoordinating on over seventy clinical research trials following the guidelines set forth by the FDAManaged and supervised other coordinators. Established a Standard Operating Procedures manualDesigned a spreadsheet that tracks every study and status of each subject in the trialNegotiating budgets for each new study.Maintain regulatory documentationTraining all new Clinical Research Coordinators in SOP, GCP and ICH guidelinesAssisting in the design of the organization's information packagePerforming database searches to recruit potential subjects for participation in a clinical trialConsistently ranked in the top five in the country in the recruitment of subjects for each trialReporting directly to the Medical Director of the companyObtain informed consent following Good Clinical Practice Conduct of clinical research procedures and patient care visits according to clinical trial protocols. Perform patient screening, randomization of screened subject according to clinical trial protocols.Perform drug accountability and reconciled counts with CRF, Source data, and dispensing logs.Completes all study documentation forms and other clinical trial specific documents, including detailed source documentation [case report form (CRF) or electronic case report form (eCRF)].Assure subjects receive appropriate medical evaluation and care, alerting the Principal Investigator of serious adverse events.Facilitates sponsor or CRO monitoring visits (site initiation, interim and close out visits) and is responsible for the completion of study queries.Attend sponsor Investigator meetings and clinical trial conference as needed for clinical trials.Assists in completing all necessary regulatory documentation and maintaining regulatory files for assigned trials where applicable.Maintain study trial master files (TMF) according to SOP.Monitor fellow CRCs study files before monitoring visits. Show less

Responsible for all laboratory specimen processing and shippingPerformed data entry on studies via paper and computerCoordinated clinical research trials following the guidelines set forth by the FDAObtain informed consent following Good Clinical Practice Conduct of clinical research procedures and patient care visits according to clinical trial protocols. Perform patient screening, randomization of screened subject according to clinical trial protocols.Perform drug… Show more Responsible for all laboratory specimen processing and shippingPerformed data entry on studies via paper and computerCoordinated clinical research trials following the guidelines set forth by the FDAObtain informed consent following Good Clinical Practice Conduct of clinical research procedures and patient care visits according to clinical trial protocols. Perform patient screening, randomization of screened subject according to clinical trial protocols.Perform drug accountability and reconciled counts with CRF, Source data, and dispensing logs.Completes all study documentation forms and other clinical trial specific documents, including detailed source documentation [case report form (CRF) or electronic case report form (eCRF)].Assure subjects receive appropriate medical evaluation and care, alerting the Principal Investigator of serious adverse events.Facilitates sponsor or CRO monitoring visits (site initiation, interim and close out visits) and is responsible for the completion of study queries.Attend sponsor Investigator meetings and clinical trial conference as needed for clinical trials.Assists in completing all necessary regulatory documentation and maintaining regulatory files for assigned trials where applicable.Maintain study trial master files (TMF) according to SOP. Show less