Contract Clinical Research Associate
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Posted by PSICRO on the hiring system it uses for its careers page; applications go straight to the company.
Can I apply?
- Contract
- Remote from Canada
- Work permit not stated
Contract Clinical Research Associate role at PSI (listed as remote, Calgary, AB) doing site monitoring across clinical studies.
Requires 5+ years of independent on-site monitoring, including independent oncology and gastroenterology (IBD) trial monitoring.
Requires a Life Sciences degree or equivalent, Canadian location on the West Coast, and a valid driver's license.
Travel of up to 75% is required, which conflicts with the 'remote' label; confirm the location and travel expectations before applying.
From the posting
- workplace
ATS workplace type: remote
- locations
ATS location: Remote - Calgary, AB, Canada
- employment types
Contract Clinical Research Associate
- remote eligible countries
Located in Canada (West Coast)
- years experience min
5+ years of independent on-site monitoring experience
- education required
College/University degree in Life Sciences or an equivalent combination of education, training & experience
- job function
Conduct project-specific training of site investigators
- role family
Clinical Research Associate
- skills
Experience independently monitoring Oncology clinical trials required
- skills
Proficiency in MS Office applications
- actionable
Perform source data verification and follows up on data queries at site level
Job description
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together close to 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Job Description As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. You will:
- Act as the main line of communication between the project team, sponsor, and the site
- Build and maintain a good relationship with the site staff involved in the study conduct
- Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
- Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
- Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
- Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level
- Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites
- Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level
- Ensures quality (data integrity and compliance) at site level
- Conduct site audit preparation visits and resolve site audit findings
- Participate in study site audits and client onsite visits, as required
- Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse
- Conduct project-specific training of site investigators
- Support preparation of Investigator newsletters
- Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level
- Support preparation of draft regulatory and ethics committee submission packages
- Support collection of IP-RED packages at site/country level
- Facilitate review and reconciliation of the study TMF on country and site levels
Qualifications
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Located in Canada (West Coast)
- 5+ years of independent on-site monitoring experience
- Experience in all types of monitoring visits, in phases I-III
- Experience independently monitoring Oncology clinical trials required
- Experience independently monitoring Gastroenterology (IBD) clinical trials required
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel up to 75%
- Valid driver’s license
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