Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we're hoping you're here for the latter.
Who are we?
We Are PRA.
We are 15,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.
Who are you?
You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Clinical Trial Associate, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you're more than an employee number. A place you love working.
Still here? Good. Because if this is you, we'd really like to meet you.
What will you be doing? As a Clinical Trial Associate , you will assists the Clinical Project Managers in the conduct of trials and may be responsible for managing startup activities, vendor communication or other project activities as assigned. He/She performs work within established protocols under general supervision.
Assists with preparation of all external and internal documentation, for assigned trials, to ensure such documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocol, under close supervision
Assists Clinical Project Manager in site management activities which could include review of monitoring report, tracking of site visits, communication with monitors and sites, and other activities as assigned
Maintains and tracks revisions to all documentation for accuracy, including patient Informed Consent Forms and Case Report Forms
Assists the Clinical Project Manager in ensuring compliance with Clinical Study Protocol and provides timely updates to assigned Clinical Project Manager to confirm compliance
Organizes and prepares study files related to study tracking and reporting and submits them to the Trial Master File within established guidelines
May participate in the training of CRO teams, investigators and staff as needed regarding assigned logistics of the clinical trial
Tracks delivery and receipt of required supplies and materials to study sites and provides regular status updates
May mentor more junior Clinical Operations Staff or participate in the on boarding of new personnel
Performs other duties as assigned
What do you need to have? Education: Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional
0 2 years of related experience
Prior experience using computerized information systems.
Read, write, and speak fluent English; fluent in host country language required
Clinical trials support or pharmaceutical industry experience preferred.
Experience with PC-Windows, word processing, and electronic spreadsheets preferred.
Office based or clinical employment experience preferred.
Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
To qualify, applicants must be legally authorized to work in Canada and should not require, now or in the future, sponsorship for employment visa status. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
PRA Health Sciences