•Assist with the preparation and coordination of Investigator Meetings, attend, and present at Investigator meetings as required.
•Participate in study training programs and maintain awareness of developments in relevant field of clinical research.
•Acts as the primary contact for site interactions and communications.
•Actively participate in planning, implementing and managing the start-up, execution and closeout activities of assigned studies.
•Ensure the timely and appropriate collection, review and submission of essential documents as required.
•Assist with the development of study manual, monitoring conventions, telephone scripts, tracking forms, and other study related documents.
•Conducts and assists with administrative activities as a member of the project team.
•Perform site management and in house study monitoring tasks for assigned sites with the sponsor and project manager, help to ensure optimal selection of Investigators and sites.
•Maintain required study documentation related to site communication and remote site management activities.
•Provide status reports to Project Manager and sponsor as required.
• Monitored investigational drug studies in phases I, II ,III and IV.
• Visited sites to assess the qualification of potential investigative sites, initiated studies, instructed site personnel on the proper conduct of studies, performed ongoing monitoring to assure site's adherence to ICH GCPs, protocol and all relevant regulations review data and ensured accuracy of data collected, and performed closeout visits.
• Performed billable work in accordance with company policies, procedures, and Standard Operating Procedures.
• Performed source document verification, retrieves Case Report Forms (CRFs) and performed query resolution in a timely manner and oversees drug accountability and safety at investigative sites.
• Mentored junior level CRAs and serves as a resource for new employees.
• Serve as a resource for and interact with other functional areas to resolve site issues and facilitated project timelines.
•Ensured accuracy of coded documents for central files, performed document scanning when applicable.
•Ensured the complete documentation and timely arrival of clinical supplies and study drugs for site visits, in conjunction with CRAs.
•Managed time, expenses and visit frequency per study guidelines.
•Responsible for the timely arrival of clinical supplies and study drugs at the sites.
•Ensured CRF pages are being processed, tracked and forwarded to Data Management on time.
•Ensured adherence to ICH GCP, applicable regulatory and legal requirements
• Responsible for up to date reports of study status in CTMS or client equivalent.
• Provided logistical support in developing and writing clinical trial documents and manuals.
• Assisted in evaluating and investigative sites and conducting co-monitoring visits
• Participated in monitoring study safety and handling data review and discrepancy resolution.
• Performed study initiation activities and reviewed protocols and regulatory issues.
• Documented accountability, stability and storage conditions of clinical trial materials according to sponsor's instructions.
•Ensured all personnel are trained and competent on all study procedures. •Ensured that all studies are carried out in strict accordance with the relevant protocols, SOPs and the specified standard of the GCPs. •Coordinated and ensured submission of documents to the IRB/IEC as appropriate for timely review.
• Served as site lead for all assigned Phase I clinical studies ensuring that studies are delivered according to Sponsor requirements on time and to high quality.
• Ensured all personnel are trained and competent on all study procedures.
• Ensured that all studies are carried out in strict accordance with the relevant protocols, SOPs and the specified standard of the GCPs.
• Coordinated and ensured submission of documents to the IRB/IEC as appropriate for timely review.
• Reviewed participant eligibility information to determine if protocol criterions are met and communicates with Investigators and PM regarding participant eligibility.
• Coordinated CRF activities as appropriate; ie: Overseen the completion of case report forms, CRF documentation and data queries.
• Ensured that biological samples are shipped as appropriate and as directed by the client, in a timely manner.
• Overseen coordination of receipt, inventory, accountability and disposal of clinical trial materials.
• Ensured that all protocol deviations or other unscheduled study events are properly documented and communicated.
• Dispensed and administered medications and vaccination to patients prior to and during deployments.
• Recorded vital signs and collected blood and urine samples to prepare for testing.
• Explained basic treatment procedures or physician instructions to patients or guardian.
• Provided follow-up care according to doctor instructions.
• Implemented patient care plan.
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