Responsible for coordinating and managing CRA activities.. Oversaw appropriate planning and tracking of monitoring visits.. Reviewed site visit reports.. Development of site management related documents(manuals, templates, and tools).. Providing CRA specific guidance, training, and coaching.. Oversaw and managed site communications and site issues untilresolution.. Oversaw centralized and risk-based monitoring activities.. Managed study progress relative to enrollment and monitoring.. Developed subject recruitment and retention strategies. . Performed site management and monitoring activities.. Conducted routine visit types.. Assisted with study start up and site feasibility processes.. Served as the primary point of contact to all sites.. Made sure sites are always audit ready.

• Responsible for performing on-site and remote monitoring visits to ensure patient safety, GCP compliance and data integrity by confirming the site is conducting the study in accordance with the protocol, ICH guidelines, and applicable regulatory requirements• Assists with investigator identification, evaluation and selection activities, as requested• Communicate the progress and relevant information or escalate issues of the study to the appropriate study management team• Conducts source document verification, performs drug accountability and reviews the investigator site file during on-site monitoring visits as outlined in the study-specific monitoring plan• Responsible for building strong, collaborative relationship with investigators and staff at assigned clinical sites.• Delivers appropriate training to site staff and other relevant parties, as required. Assists with web based and face to face trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively run the clinical• Participate in global investigators and/or monitor meetings as appropriate. Facilitates investigator’s participation in global meetings and/or may assist the study staff with organizing local investigator Participates in other study meetings as required.• Maintain good relationship with sites and ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are• Ensure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP).• Work with the sites to ensure they address data queries in a timely Verifying that data entered in to the CRFs is consistent with patient medical notes and entered in real time.• Ensure Investigator and site staff receives safety reports.

Responsible for performing on-site and remote monitoring visits to ensure patient safety, GCP compliance and data integrity by confirming the site is conducting the study in accordance with the protocol, ICH guidelines, and applicable regulatory requirementsAssists with investigator identification, evaluation and selection activities, as requestedCommunicate the progress and relevant information or escalate issues of the study to the appropriate study management teamConducts source document verification, performs drug accountability and reviews the investigator site file during on-site monitoring visits as outlined in the study-specific monitoring planResponsible for building strong, collaborative relationship with investigators and staff at assigned clinical sites.Delivers appropriate training to site staff and other relevant parties, as required. Assists with web based and face to face trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively run the clinical