Brentwood, Tennessee, United States
Accomplished Clinical Lead/Clinical Trial Manager with a certification in clinical research and 18+ years experience managing/monitoring phase I - IV clinical trials for large global clinical research organizations and sponsor pharmaceutical companies. Proven manager/monitor with experience in all phases of feasibility, pre-study site selection, site start-up, site initiation, routine monitoring and site close-out of clinical trials. Focused on meeting Sponsor requirements through creative problem solving with adherence to Good Clinical Practice and regulatory authority guidelines. Ability to manage multiple initiatives, meet deadlines, and adjust to changing business priorities quickly and effectively.
Pharmaceutical and Medical Device research and development consultant
• Review of protocols and other study documents • Monitoring clinical research sites' continued qualification for conduction and participation in clinical research (documented IRB initial and continued review and approval to conduction clinical research and review and approval to implement the Sponsor protocol(s); documented qualification of clinical research staff, facilities; documented initial and continual approval of the clinical research site from Sponsor, etc.) • Conducting site qualification visits, site initiation visits, interim monitoring visits and close-out visits • Recording the conduction of site visits in accordance with the monitoring plan and in accordance with appropriate visit report template(s) • Conducting non-in-person site reviews and recording in accordance with monitoring plan using the proper template • Conducing verbal communications, written communications and any other form of communication with clinical research sites in accordance with monitoring plan, using the proper template(s) • Attending all required meetings • 100% compliance, at all times, with required trainings • Accurate assessment and documentation of investigation products and other clinical supplies • Assisting in the subject recruitment and retention strategies • Proper and timely escalation of issues.
• Complete project activities associated with monitoring functions of Phase I-IV clinical research studies while demonstrating mastery and a deep understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations. • Provide clinical and technical support for Clinical Research Associates (CRA) I, II, and III and administrative staff • Perform management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures • Responsible for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assure timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol violations; ensure proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly review the status of the contents of the site regulatory binder; exhibits superior time management skills; may perform training visits with less experienced CRAs; and may perform assessment of less experienced CRAs during the sign-off visits • Complete and submit reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions. Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs • Update study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA, track Investigator payments/milestones • Document and track the resolution of all outstanding site-specific protocol-related issues from visit to visit
• Assist with protocol and CRF development and review • Develop informed consent forms • Conduct study feasibility and site selection activities • Assist with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials • Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities. • Conduct site management activities, including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits. • Write study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines • Ensure proper storage, dispensation and accountability of clinical supplies and study drug. • Follow up of drug safety issues and safety reports in timely manner • Input and maintain study information concerning subject status of financial reimbursement to sites • Mentor for Site Managers • Conduct on the job training and formal training to other CRAs and Clinical Trials Assistants • Collaborate with Regional Monitoring Manager or Clinical Operations Manager /study teams to resolve site issues • Review study visit reports, follow-up letters and site communication generated by other CRAs for timeliness, quality, consistency, and appropriate documentation and resolution of issues
• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines o Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies o Provides regular clinical status information to team members and project management o Performs billable work in accordance with PRA policies, procedures, and Standard Operating Procedures (SOPs) o Works closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff o Communicates common site trends to the Project Management Team • Performs investigative site file reconciliation; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and sponsor requirements o Performs source document verification, retrieves Case Report Forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites o Ensures Serious Adverse Event (SAE) reporting according to project specifications o Responds to requests from investigative sites in a timely fashion