One month before the last newsletter was released. Theralase hired Anita Andoh for the clinical study coordinator position. The August 2021 advertisement for the position contains a lot of information about how Theralase manages the trial including information about
Also interesting, given the misapplication of the protocol in the treatment of the first 12 patients, is this responsibility: "
Discuss and verify compliance of clinical study protocol and ICF updates with PIs and CSS coordinators."
Clinical Study Coordinator
Theralase Technologies Inc. - Toronto, ON
$75,000 a year - Full-time, Temporary, Contract, Permanent
Clinical Study Coordinator (“CSC”)
Overview:
Theralase® Technologies Inc. (“Theralase®”) is a publicly traded Canadian federal corporation (TSXV: TLT; OTCQB: TLTFF), which consists of two divisions; specifically:
1) The Anti-Cancer Therapy (“ACT”) division, which is a clinical stage, pre-commercialization research and development division dedicated to the research and development of Photo Dynamic Compounds (“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers, bacteria and viruses, when light activated by proprietary medical laser systems.
2) The Cool Laser Therapy (“CLT”) division, which is a clinical stage, commercial division that designs, manufactures and distributes proprietary super-pulsed CLT medical lasers, primarily in Canada and the United States, for the treatment of knee pain, and in off-label use, treatment of numerous nerve, muscle and joint conditions. The CLT division also designs and manufactures the proprietary medical laser systems used to activate the PDCs in the ACT division.
Additional information is available at www.theralase.com and www.sedar.com
Description:
The successful candidate for the Clinical Study Coordinator (“CSC”) will have 5+ years of hands-on experience in the coordination, administration and management of multiple Clinical Study Sites (“CSSs”) in the successful completion of sponsored oncological clinical studies.
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 study’s 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 study’s 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 sponsor’s 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 patient’s 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.
Skills and Qualifications Required:
· University education with a bachelor’s or master’s degree in Biology, Biomedical Sciences or Biochemistry
· 5+ years of hands-on experience in the coordination, administration and management of multiple Clinical Study Sites (“CSSs”) in the successful completion of sponsored oncological clinical studies.
· Certified Clinical Research Coordinator (“CCRC”) (Preferred) or Clinical Research Associate (“CRA”) designation
Advanced skills in the Microsoft Office environment (Office, Excel, Outlook, Word, Power Point, Publisher)
Excellent oral, written and presentation communication skills in the English language
Able to maintain strict confidentiality of clinical records
High knowledge level of clinical study protocols
Proven ability to achieve strategic objectives
Self-disciplined, self-motivated and professional in demeanor
Polished individual who remains calm and focused under pressure and who rises to meet the challenge
Deadline orientated with an ability to meet tight deadlines
Organized, with an ability toprioritize in a multi-tasking environment with excellent attention to detail and accuracy
Enjoys working in a challenging and fast growth environment
Demonstrated flexibility and adaptability with an ability to learn from past performance and implement strategies to improve performance and achieve strategic objectives on time
· Able to accurately prepare and publish training materials for PIs, CSS coordinators, third-party audit organizations and/or other third-party service providers
· Able to research, analyze and summarize information from professional journals, technical procedures and/or governmental regulations to present that information in executive form for review by senior management
· Able to effectively, accurately and succinctly respond to questions from PIs, CSS coordinators, third-party audit organizations and other third-party service providers in a timely manner
· In-depth GCP training and knowledge of drug development process and the regulatory submission requirements for US FDA, Health Canada and the European Medical Association (“EMA”)
· Able to travel to the USA and within Canada for 2 to 5 day pre-arranged business trips, as required, subject to COVID-19 restrictions
Compensation:
Up to $75,000 base, commensurate with experience + performance bonus + employee benefits + stock options (subject to board of director’s approval)
Please send your resume for review and consideration.
Only candidates, who are being considered for the COO position will be contacted.
Benefits:
Extended health care
Vision care
Dental care
Expected start date: 2021-09-07
Job Types: Full-time, Contract, Permanent
Salary: Up to $75,000.00 per year
Additional pay:
Bonus pay
Benefits:
Casual dress
Dental care
Extended health care
On-site gym
On-site parking
Stock options
Vision care
Schedule:
8 hour shift
Monday to Friday
Overtime
COVID-19 considerations:
All employees and visitors are required to wear a mask when not in their offices or respective work stations. The office area, kitchen and washrooms are cleaned and sanitized 3 times a week
Education:
Bachelor's Degree (required)
Licence/Certification:
Certified Clinical Research Coordinator (required)
Work remotely:
No