Part-Time Study Documentation Associate, Early Phase (Canada)

Do you want to be a part of a global top 10 CRO? INC Research is a full-service contract research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we’ve continued to improve what we do. 


At INC Research Early Phase we pride ourselves on being the best in-class provider of Early Phase Clinical Development Services. With expertise in Abuse Liability, CNS, and Alcohol Interaction Assessments our highly trained staff offer us a competitive edge. Located in the heart of downtown Toronto our 36,000 square foot clinical research facility is a unique space which offers exciting opportunities for registered nurses, paramedics, physicians and other clinical research professionals. We look for highly motivated, “can-do” employees who don’t accept ordinary. 

We are currently looking to strengthen our growing team in Canada and are seeking a part time Study Documentation Associate to join our Early Phase business unit based in Toronto, ON. 

Core responsibilities: 
A brief summary of duties you will be involved in: 

• Reviews and understands study protocols and other protocol-related documents (Clinical Research Form (CRF), lab manual, etc.), specifically clinical conduct and events. 

• Identifies and develops source document templates to accurately capture clinical trial data per the approved study Protocol, SOPs, or Study Instruction Sheet. 

• Collaborates within and between teams to ensure source documents are established in accordance with clinic flow, CRF compatibility, and other study requirements. 

• Collaborates within and between teams during internal and external review of source documents ensuring review and finalization of documents are met within specified timelines. 

• Responsible for development and appropriate revision, approval, version, and access control of all source documents and form templates. 


Qualifications:


Skills and attributes: 
To succeed in this role you will need the following skills/experience: 

• College degree or equivalent education and experience. Up to 2 years of experience in clinical research. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. 

• Excellent attention to accuracy and detail. Ability to disseminate information. Strong verbal and written communication skills. Ability to perform several tasks simultaneously to meet deadlines. 

Why choose us: 
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry. 

We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here; and because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. This means we can take our careers wherever we want them, too. 

“We were ranked “Top CRO” to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).” 
What happens next: 

If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity. 

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. 

Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.