RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:News: CEO ExitsHi CancerSlayer - I agree Shawn probably resigned. If he was let go Theralase was remiss in not finding an appropriate replacement. Judging by the duties and responsibilities listed in the ad the clinical study coordinator has a lot to do and I doubt that Shawn has kept up with it all since Sharath Jakkani left the company. I hope they hire someone soon. The CSC will be responsible for: 1) Primary - Implementing, coordinating and managing all CSSs in the timely completion of all clinical procedures, assessments and documents, in compliance with the clinical protocol and regulatory requirements 2) Secondary Daily management of CSSs to ensure the accurate and timely input of clinical assessments into the clinical studys Electronic Data Capture (EDC) database 3) Tertiary Summarize the EDC database into Theralase internal spreadsheets for reporting to senior management, the board of directors and corporate stakeholders 4) Quaternary - In collaboration with third-party audit organizations or independently, coordinate and ensure timely completion of Site Qualification Visit (SQV), Site Initiation Visit (SIV), CSS monitoring visits and close-out visit The CSC will ensure the accurate and timely completion of the EDC for future database lock, submission to the biostatistician team for analysis and subsequent submission to Health Canada and the Food and Drug Administration (FDA) for marketing regulatory approval. Duties and Responsibilities: In collaboration with Principal Investigators (PIs), CSS coordinators, CSS administrative staff, Clinical Research Organizations (CROs), third-party auditing organization and other third-party service providers, administrate and manage all aspects of Theralase sponsored clinical studies at multiple CSSs. Review the clinical study protocol, Informed Consent Form (ICF), Research Ethics Board (REB) documentation, EDC and patient files for each CSS to understand the current status of the clinical study. Maintain and keep current the clinical studys EDC database by analyzing and following-up all open queries (in-house or via audits conducted by CSC, CRO, regulatory authority and/or third-party auditing organization) with each CSS coordinator to ensure their timely closure (within 2 weeks of data collection). Author, review, distribute and update version controlled Standard Operating Procedures (SOPs) and adhere to SOP Good Clinical Practices (GCP). Assist CSSs to update and remain in compliance with version controlled clinical study protocols and ICFs. Keep track of study activities to assure compliance with clinical protocols and with all related local, municipal, provincial, national and international regulatory and institutional polices. Research, prepare and publish digitally e-training materials and review tests for study drug, study device and study treatment training for all CSS PIs, coordinators and third-party auditing organizations. Review and update e-training materials to mirror version controlled clinical study protocols and ICFs, as required. Provide log-in credentials for e-training sessions to CSS PIs, coordinators and third-party auditing organizations and for those individuals who do not fully understand the e-training materials, based on their test scores, contact them to more succinctly address their questions. Specify, manage and ensure timely completion of required updates to EDC master program with programming assistance provided by third-party organization. Monitor pending enrollment, enrolment, treatment and assessment status of patients at each CSS and timely completion of this clinical information in the EDC by the CSS coordinators. Provide feedback to CSS PIs and coordinators regarding inconsistent or confusing EDC clinical data for clarification. Record patient dropout / lost to follow-up / removal of informed consent patient details in EDC. Review clinical study protocol updates and ICFs, prior to implementation to ensure compliance with sample collection procedures and EDC data recordation. Discuss and verify compliance of clinical study protocol and ICF updates with PIs and CSS coordinators. Prepare clinical study-related documents and forms such as clinical protocol worksheets, Adverse Event (AE) reports, Institutional Review Board (IRB) / REB documents, procedural manuals and progress reports. Coordinate supply and re-supply of study drug, study device and study device consumables to all CSSs, as required. In collaboration with third-party audit organizations, coordinate and ensure timely completion of SQV, SIV, CSS monitoring visits and close-out visit. Ensure that AEs are properly documented in the EDC and followed by the PI and the CSS coordinators for timely resolution. Ensure that Severe AEs (SAEs) reported by the PI and confirmed by Theralase are reported per clinical study protocol procedures and documents to the respective REBs, regulatory authorities and to other CSSs, as required. Review all laboratory results and follow clinical protocol procedures and documents regarding abnormal results. Review all potential patient enrollments to ensure compliance with the clinical protocol, and after reviewing and providing their assessment to senior management, report back the sponsors decision on enrollment to the CSS. Prepare, manage and file all regulatory documents, required per clinical study protocol procedures and documents. Monitor all patient screening, treatment and assessment visits with CSSs to ensure clinical protocol procedures and documents are completed on a timely basis (within 2 weeks of data collection). Review and monitor the accurate completion of electronic Case Report Forms (eCRF) by comparing them to the patients confidential medical records during audits conducted personally or by third party CROs. Prepare and update Theralase internal spreadsheets on patient screening, study treatment, assessment status and study treatment success / failure analysis to provide senior management a weekly update of study performance to primary, secondary and tertiary clinical study objectives. Update finance and senior management on study treatment completion for financial payment of CSS invoices.
CancerSlayer wrote: Eoganacht wrote: If he was let go why didn't they have a replacement ready? The new guy is not a good fit for CEO of a company in the middle of a pivotal phase 2 trial. He looks like a good fit for the cold laser division and it would be great if they got that part of the business to pull its own weight. But as of right now, who's running the trial?
CancerSlayer wrote: A happy/confident/performing CEO wouldn't exit "prior" to his big payday (buyout)...
Hi Eoganacht...I guess you took my statement literally. I wasn't suggesting Shawn was a happy/etc. CEO...imo, he was quite the opposite & likely resigned is my guess. The concern is not only FDA/regulatory body communications, but who the heck is going to write a clear/concise release re: interim results/scientific updates or even a quarterly newsletter for that matter...hence the delay. I believe Dr. Mandel will have to carry much of Shawn's load in the interim?