Clinical Trials Specialist

Job Title : Clinical Trials SpecialistHours : 35 HRS / week; 9 : 00-5 : 00, Monday-FridayStatus : Full TimeLevel : Minimum 2 Years ExperienceLocation : Toronto, ONPosition : Combination in-office and remote positionOzmosis promotes a strong team environment and is seeking a new valued member of our team.

If you have experience in oncology, clinical trials management, project management and would appreciate the opportunity to work in a setting that moves clinical research forward, we would be interested in hearing from you.

Ozmosis Research Inc. is an independent, entrepreneurial clinical trials management company in Canada operating as a social enterprise (not for profit).

We are a trusted partner for biotechnology and pharmaceutical companies as well as academic institutions and investigators, and we have an impressive track record of success in clinical research.

We provide our expertise to pharmaceutical and biotechnology companies to help them succeed with the design and implementation of their Phase I, II and III clinical trials.

We offer services provided by traditional CRO’s with a distinct advantage our clinical research and oncology experience and our network of contacts at leading centres in Canada, US, and Europe.

RESPONSIBILITIESThe Clinical Trials Specialist (CTS) participates in the development, coordination, data and project management of clinical trials from protocol development / review, approval through to activation, follow-up and trial closure.

The CTS is responsible for a wide variety of projects involving phase I, II, and III trials for various investigator-initiated sponsors, pharmaceutical, and biotechnology companies.

Principal responsibilities may include : Project managementCoordinating single and / or multicentre studiesProtocol development, writing, and amendmentsRegulatory complianceSite ManagementCommunication with various stakeholders including sites, staff, and sponsors at all levels.

Vendor ManagementUtilize quality assurance procedures to ensure that high quality data is obtained.Ensuring studies are conducted in accordance with ICH-GCP, Health Canada, FDA and US Federal Code, as well as other regulatory agencies.

QUALIFICATIONSEducationAt minimum, completion of a Bachelor's of Science degree or recognized equivalentExperienceAt least 2 years of experience in some or all of oncology, clinical trials management, project management, regulatory issues involving human subjectsProfessional Affiliations / MembershipsSoCRA or ACRP designation, preferredSkills & Functional / Technical CompetenciesExperience in project and site managementPossess initiative and good judgment with the ability to multi-taskAbility to work under pressure and attention to detailDemonstrated proficiency in English grammar, with excellent oral and written communication skillsExcellent organization, prioritization skills, and the ability to learn quickly and work independentlyAbility to perform duties in a professional and courteous manner and produce high quality work while meeting deadlinesAbility to work well as part of a teamKnowledge of applicable legislation and regulationsDemonstrated proficiency in MS Office Suite (Word, Excel and PowerPoint)Experience in Oncology and Medidata Rave an assetIf you have experience in oncology, clinical trials management, project management and would appreciate the opportunity to work in a setting that moves clinical research forward, we would be interested in hearing from you.