Clinical Study Coordinator

Position: Clinical Study Coordinator ("CSC")

Clinical Study Coordinator (“CSC”) responsible for the coordination, hands-on treatment (single site only), management and follow-up of patients with various conditions enrolled in various Company sponsored Phase III clinical studies at single or multiple clinical study sites using the Theralase medical laser system (“Product”), currently approved for the treatment of knee pain in Canada and the United States. 

Reports to: Director of Clinical Education, Training and Customer Support (“Director of CETCS”) 

Duties and Responsibilities:

  • Under the direction of the Director of CETCS and in compliance with a Research Ethics Board (“REB”), external consultants (biostatistician, Clinical Research Organizations (“CROs”)) and regulatory organizations (Health Canada, Food and Drug Administration (“FDA”) and Conformité Européenne (“CE”)), the CSC will be responsible for the coordination, hands-on treatment (single site only), management and follow-up of patients enrolled and treated in various Phase III clinical studies at single or multiple clinical study sites 
  • Ensure compliance with Standard Operating Procedures (“SOPs”) and clinical protocols by all patients and Principal Investigators (“PIs”) 
  • Ensure patient has been examined by the Director of CETCS according to the inclusion and exclusion criteria and has executed an Informed Consent Form (“ICF’), prior to being enrolled or treated in a Phase III clinical study 
  • Maintain adherence to Good Clinical Practices (“GCP”) and assist clinical study sites to remain in compliance with ICF and clinical study protocol 
  • Keep track of clinical study activities to assure compliance with all local, provincial, state, national and international regulatory and institutional polices 
  • Conduct random quality assurance audits to ensure compliance with GCP guidelines 
  • Monitor enrolment status of patients, collect and securely store all clinical data and record dropout / lost to follow-up details 
  • Provide a review and feedback of ease of administration of the clinical study protocols to the Director of CETCS to optimize SOPs and resolve patient dropout / lost to follow-up or data collection issues 
  • Prepare clinical study-related paperwork such as clinical protocol worksheets, Adverse Event (“AE”) reports, REB documents, procedural manuals and progress reports 
  • Discuss clinical study protocols with PIs and verify that each patient has a current signed ICF 
  • Coordinate and maintain in good working order Study Devices (control and active) at all clinical study sites by working with production to address and performance or calibration issues that arise 
  • In collaboration with Director of CETCS for external clinical study sites, coordinate and conduct Site Qualification Visit (“SQV”), Site Initiation Visit (“SIV”), PI training on the Study Device, scheduled and random clinical study site monitoring visits and close-out visit 
  • Ensure that AEs are properly documented and reported by the clinical study site, and when identified by the PI as Serious Adverse Events (“SAE”) and confirmed by the Sponsor, are reported per guidelines to the Study REB, regulatory authorities and to other clinical study sites 
  • Review all clinical study data and follow up with clinical study sites on abnormal data to check veracity 
  • Working with the Quality and Regulatory Affairs Coordinator, ensure that all regulatory documents are prepared and filed according to guidelines 
  • Monitor all patient visits and work with clinical study sites to ensure SOPs are consistent with clinical protocol requirements 
  • Review paper and/or electronic Case Report Forms (“CRF”) per regulatory guidelines and compare them against the patient’s medical record for completeness and accuracy 
  • Other duties as assigned by the Director of CETCS 

Skills and Qualifications Required: 

  • Ability to achieve and/or surpass Clinical Study Coordinator (“CSC”) strategic objectives in the timely and successful completion of Phase III clinical studies with the Product 
  • University B.Sc. degree in biological sciences 
  • 5+ years of proven work experience as a CSC 
  • Certified Clinical Research Coordinator (“CCRC”) 
  • Ability to read, analyze and interpret information from professional journals, technical procedures or governmental regulations 
  • Ability to clearly and effectively present information in verbal, written, digital and presentation format and respond to questions from PIs, REBs, CROs and other external consultants 
  • Knowledge of GCP and the regulatory submission requirements for medical devices to the US FDA, Health Canada and Conformité Européenne (“CE”) 
  • Ability to complete tasks independently, as well as function effectively in a team setting 
  • Demonstrate consistent professional conduct and meticulous attention to detail 
  • Must possess excellent verbal, written and interpersonal communication skills 
  • Self-disciplined, self-motivated, hardworking and professional in demeanor 
  • Proven ability to build positive relationships at all levels of an organization 
  • Polished individual who remains calm and focused under pressure 
  • Enthusiastic and energetic in the completion of their assigned tasks, meeting deadlines and delivering results 
  • Organized with the ability to prioritize in a multi-tasking environment with excellent attention to detail 
  • Self-starter with the ability to work independently under minimal supervision 
  • Strong personnel skills with proven ability to overcome objections and achieve objectives 
  • Demonstrated resilience, passion and commitment to deliver 
  • Enjoy working in a challenging and fast growth environment 
  • Positive, “Can-Do” attitude and strong belief in personal accountability 
  • Proactive interest and motivation in pursuing continual learning and self-development 
  • Strive to constantly improve and develop skills both personally and in assisting their colleagues to do the same 

Compensation:

$50,000 to $60,000 base, commensurate with experience + performance bonus + employee benefits (after 3 months) + stock options, subject to board of director approval. 

Theralase® is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Theralase® is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

 

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Clinical Study Coordinator Job Application