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Clinical Trial Study Assistant
The main purpose of the position is to own and hands-on assist in the management of one or two clinical studies at level 1 or 2 of the HOYA Clinical Study House. • Set up / manage / maintain clinical study documentation: ensure receipt, completeness and accuracy of clinical and administrative documents • Assist in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports; • Prepare and maintain Trial Master File (TMF) • Assist in the coordination of study initiation documentation materials • Coordinate the ordering, receipt, distribution of investigational devices to investigator sites and maintain tracking of these devices at the sites • Development and maintenance of all study documentation • Day-to-day assistance in the management of CRO • Assist in Day-to-day monitoring of the study to ensure compliance, data quality and adherence to timeline. • Assisting in the organization of Clinical Team, Investigator and CRO Meetings • Assist Resolution of study related problems (e.g. enrolment speed, protocol deviations, serious adverse events) • Relationship management supporting teams • Assist with Management of study timelines EDUCATION: Bachelor degree physical sciences, engineering science, or a relevant field. Must be thoroughly familiar with ISO 14155 (GCP). EXPERIENCE: Preferably at least 1-2 years of experience in clinical studies in medical device industry. CRA experience a plus. SKILLS: Excellent interpersonal and written communication skills; pragmatic in problem solving; compliance mindset; systematic and disciplined. HOYA Surgical Optics is an equal opportunity employer. All qualified candidates are encouraged to apply. Local candidates only.

Company: HOYA Surgical Optics
Contact Person: Guy Hornbeck
Contact E-mail: guy.hornbeck@hoya.com
Phone: 408 654-2211
Address: 15335 Fairfield Ranch Road, Sutie 250
Chino Hills, CA +1709
USA
   


Clinical Trial Study Assistant
The main purpose of the position is to own and hands-on assist in the management of one or two clinical studies at level 1 or 2 of the HOYA Clinical Study House. • Set up / manage / maintain clinical study documentation: ensure receipt, completeness and accuracy of clinical and administrative documents • Assist in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports; • Prepare and maintain Trial Master File (TMF) • Assist in the coordination of study initiation documentation materials • Coordinate the ordering, receipt, distribution of investigational devices to investigator sites and maintain tracking of these devices at the sites • Development and maintenance of all study documentation • Day-to-day assistance in the management of CRO • Assist in Day-to-day monitoring of the study to ensure compliance, data quality and adherence to timeline. • Assisting in the organization of Clinical Team, Investigator and CRO Meetings • Assist Resolution of study related problems (e.g. enrolment speed, protocol deviations, serious adverse events) • Relationship management supporting teams • Assist with Management of study timelines EDUCATION: Bachelor degree physical sciences, engineering science, or a relevant field. Must be thoroughly familiar with ISO 14155 (GCP). EXPERIENCE: Preferably at least 1-2 years of experience in clinical studies in medical device industry. CRA experience a plus. SKILLS: Excellent interpersonal and written communication skills; pragmatic in problem solving; compliance mindset; systematic and disciplined. HOYA Surgical Optics is an equal opportunity employer. All qualified candidates are encouraged to apply. Local candidates only.

Company: HOYA Surgical Optics
Contact Person: Guy Hornbeck
Contact E-mail: guy.hornbeck@hoya.com
Phone: 408 654-2211
Address: 15335 Fairfield Ranch Road, Sutie 250
Chino Hills, CA +1709
USA
   


QA Director Job Posting
Population Health Research Institute is a vibrant and highly successful academic research institute which has over 40 clinician researchers and 300 research staff with full capabilities in all aspects of clinical research conduct. PHRI is located in Hamilton, Ontario, Canada and is affiliated with McMaster University and Hamilton Health Sciences. We are a research coordinating center which conducts high impact large, multi-center clinical trials and observational studies, many of which have changed medical practice. PHRI is the highest ranked research institute in Canada and was ranked no. 7 in the world in 2012. The PHRI publishes about 300 papers each year with a high proportion in leading clinical journals. As an academic research institute, PHRI’s environment is one that includes and requires, critical thought and analysis with evidence based decision making. With the traditional Quality Assurance structures of Standard Operating Procedures (SOPs), Audit and Corrective and Preventative Actions (CAPA) in place, PHRI as an organization is moving to quality systems approach. As such, the Quality Assurance Director requires clear understanding of goals and practices in academic research conduct and demonstrate an understanding of how to integrate scientific design and methodologies as integral components of quality and compliance. PHRI is a leader in promoting sensible guidelines and pragmatic clinical trials and is looking for a progressive Quality Assurance leader to continue to foster the adoption and implementation of these concepts. With the recent changes and revisions in guidelines toward quality and risk management, this is especially important to be active in influencing this change. The Quality Assurance Director will participate as part of the Executive team at PHRI, reporting to the Chief Operating Officer. This position will be required to maintain comprehensive and appropriate set of procedures; direct conduct of the audit program; assess and advise study leadership and PHRI Executive on level of compliance and risk with regulatory requirements and; implement quality assessment and plan at a study level. Key experience, traits and skills for the successful candidate will include: - Demonstrated Clinical research operations experience - Demonstrated Quality system / management - Experience in integrating quality objectives within operations. - Leadership for innovative quality practices; - Represent PHRI in engaging Pharma Industry partners in Quality System approach - Established leadership in progressive quality education and teaching; - Demonstrated understanding of intent of regulatory requirements to lead in compliance strategies based on risk assessments. - Lead teams in development of

Company: Population Health Research Institute
Contact Person: Susan Ercole
Contact E-mail: susan.ercole@phri.ca
Phone: 905-521-2100 ext 40335
Address: 237 Barton St. E
Hamilton, ON L8L 2X2
CANADA
   

 

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