Clinical Research Assistant (SRI) - Evaluative Clinical Sciences - Temporary Part-time 2024-10449

(Temporary Part-time, mid October to mid March)

Hours: Approx 22.5 hours per week

The Sunnybrook Research Institute is seeking a Temporary Part-time Clinical Research Assistant for the Dermatology Department.

Job duties:

• Prepare/update PI CV on relevant platforms (e.g., WebCV, CIHR)

• Coordinate and monitor all study activities to ensure proper execution of assigned research studies and to ensure that study protocols are met.
• Prepare and maintain administrative logs and trackers, including but not limited to study protocols, REB Submissions, Data CRF, study visits, etc.

• Manage and maintain a controlled records management system for electronic trial master file and related clinical trials.

• Prepare and maintain administrative logs and trackers, including but not limited to study protocols, REB Submissions, Data CRF, study visits, etc.

• Liaise with PI, organizing study visits for participants.

• Prepare study and site level Regulatory Ethics submissions and attain Regulatory Ethics approval, including but not limited to Initial Ethics submissions, Renewal submissions, SAE Reports submission, Protocol Deviations submission, Study Advertisements submission, etc.

• Coordinate site training as applicable (i.e., Protocol related training, technical training, eCRF training, SIV etc.).

• Plan, implement, and coordinate all aspects of data collection and source documentation as per study protocol. Responsible for data entry using study databases.

• Facilitate the collection, filing and tracking of study visits, surveys documents and other related study documents, including monitoring reports.

• Coordinate subject visit schedules as per study protocol, executing all aspects of study visits (i.e., assessments, documentation of adverse events and medications, administer questionnaires, sample collection, and other related responsibilities as required).

Qualifications:

• Completed post-secondary degree in a science or healthcare related discipline, or equivalent work experience

• 1+ years’ work experience as a Clinical Research assistant or similar role (preferably with SRI experience)

• Certification in clinical research is an asset

• In-depth knowledge of the clinical research process, from study start up to close out

• knowledge of ICH guidelines and GCP including basic understanding of regulatory requirements

• Strong understanding of the regulatory process and establishing and maintaining clinical study source documents

• Advanced use of Microsoft Office Word, Excel, and PowerPoint

• Excellent problem solving, communication, multitasking and interpersonal skills

• Ability to work independently, in a fast-paced environment with a high degree of organization

• A self-motivated individual who is organized and responsible.
• Fast learner and motivated to provide great service and demonstrate initiative to improve the clinic flow and patient experience.
• Courteous and respectful towards patients and staff.
• High level of integrity and respectful of patient confidentiality.
• Excellent communication skills, both written and verbal.
• Strong computer skills
• interest to learn and continually improve upon medical knowledge to better assist patients.

Qualified candidates are invited to submit a cover letter and resume to shelley.racicot@sunnybrook.ca

We thank all candidates for their interest but only candidates selected for an interview will be contacted.

The Sunnybrook Research Institute is committed to providing accessible employment practices in compliance with the Accessibility for Ontarians with Disabilities Act (‘AODA’). If you require accommodation for disability during any stage of the recruitment process, please indicate this in your cover letter.

Sunnybrook Research Institute is strongly committed to inclusion and diversity within its community and welcomes all applicants including but not limited to visible minorities, all religions and ethnicities, persons with disabilities, LGBTQ persons, and all others who may contribute to the further diversification of ideas