Indero
Location
Calgary, Alberta
The Senior CRA conducts site qualification, initiation, monitoring, and close-out visits to ensure clinical trials adhere to protocols and regulatory standards. They also build relationships with investigators, perform source data verification, and may mentor other CRAs while overseeing site metrics.
Candidates must hold a B.Sc. in a relevant field and possess at least 5 years of on-site clinical monitoring experience within the biotechnology, pharmaceutical, or CRO industry. Strong knowledge of ICH/GCP standards and experience in rheumatology are required, with dermatology experience considered an asset.
Senior Clinical Research Associate, Dermatology & Rheumatology, Alberta, Canada
The senior clinical research associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
You are a seasoned Clinical Research Associate (CRA) who thrives in autonomous environments and consistently meets high-quality standards and deadlines. You bring experience in dermatology and rheumatology, and you're eager to deepen your expertise in these therapeutic areas. You value working within a mid-sized CRO where your contributions are visible, appreciated, and have a direct impact.
The senior clinical research associate (CRA): Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines and applicable regulations Participates in investigators’ meetings Prepares site visit reports and follow-up letters to the investigator Builds productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets Performs source data verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate
Reviews and approves site visit reports. Tracks site visit and trip report metrics and escalates issues to project teams. Recommends potential solutions to identified issues and work with the project managers to find resolution. Supports the development of annotated site visit reports, clinical monitoring plans, and monitoring tools. Supports the preparation and development of materials related to the training of CRAs. Mentors CRAs. Conducts on-site quality control visits with CRAs.
Education B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience Experience At least 5 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry Rheumatology exposure Knowledge and skills Good knowledge of ICH/GCP standards and applicable regulatory requirements Strong verbal and written communication skills in English Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines Excellent judgement and problem-solving skills Travel to research sites approximately 65% of the time Excellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint) Experience in dermatology
Our company The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. Recruitment process: what to expect As part of the recruitment process for this position you will meet various team members at Indero The first interview will be conducted by Teams (30 minutes) and the second via video conference (1 hour)
A Global Clinical Leader In Dermatology and Rheumatology!
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero only accepts applicants who can legally work in Canada.
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