Eupraxia is hiring - Lead Clinical Research Associate, Clinical Operations

About Us:

Eupraxia Pharmaceuticals Inc. is a publicly owned novel pharmaceutical company based in Victoria, British Columbia. We are drug delivery company that focusses on delivering the right therapeutics to the right area in the right dose to improve patient lives. Our lead product candidate is an extended-release steroid intended to provide long term pain relief for patients suffering with knee osteoarthritis and we are actively expanding our portfolio of products.

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We are looking for people that like to be part of a fast-paced, growing company that fosters creative spirit and integrated teamwork and are eligible to work within Canada.

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Job Description:?

The Lead Clinical Research Associate, Clinical Operations will oversee and ensure the appropriate operation and completion of clinical trials in selected sites.

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They will achieve this by assessing the trial site and applicable personnel on an ongoing basis, adhering to protocol regulatory requirements, good clinical practice regulations, and standard operating procedures.? They will also ensure compliance with the patient-consent processes, verifying the receipt, handling, accounting, storage conditions, and availability of clinical products under investigation. The CRA will routinely verify compliance and quality of collected data, and as necessary verify compliance with the procedures to apply in the event of serious adverse events and verify investigator records and checks for consistency with the contents of sponsor files.

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Key Responsibilities:

·???????? Gain an in-depth understanding of the study protocol and related procedures

·???????? Provide oversight of clinical monitoring activities performed by external vendors, including co-monitoring visits. Reviews and provides oversight of the clinical monitoring plan

·???????? Identifies objectives for scheduled monitoring visits; ensures planned visit objectives are achieved to meet protocol and SOP timelines.

·???????? Provides oversight of Reviews CRO-generated monitoring reports. Identify problems at sites; resolve issues and escalate as appropriate.

·???????? Assesses site qualification potential: reviews study requirements and pre-study evaluation reports.

·???????? Supports and/or leads audits/inspection activities as needed

·???????? Assume ambassadorial role to facilitate communication between sites and Eupraxia to increase value proposition to investigators.

·???????? Organize and make presentations at Investigator Meetings

·???????? Participates in the implementation of clinical studies; communicates with investigators and their staff; ensures compliance with terms and conditions; properly trains site personnel and writes initiation visit reports.

·???????? Supervises the conduct of clinical studies: acts as liaison between site personnel and the sponsor; performs monitoring in the field; ensures compliance with protocols, regulatory requirements, and good clinical practices; writes follow-up visit reports.

·???????? Ensures the quality of the project verifies materials and data integrity; assists site personnel with internal audits or regulatory inspections; and perform ongoing follow-up with the in-house project team.

·???????? Closes clinical studies verifies the integrity of investigator files; ensures availability of clinical and non-clinical materials; jointly reviews with investigators the obligations inherent at the end of the study and writes closure visit reports.

·???????? Maintaining awareness of overall developments in the field of clinical research.

·???????? Ensuring appropriate, comprehensive, and professional communications both internally and externally.

·???????? Actively participate in the Clinical, Regulatory, and associated business teams to build and sustain long-term working relationships across all functions.

·???????? Act as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement.

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Qualifications:

·???????? College nursing diploma or Bachelor of health sciences, nursing, biomedical sciences, pharmacy, pharmacology, or a related discipline.

·???????? Master’s degree in one of the aforementioned disciplines or another postgraduate degree1 (ideal).

·???????? SOCRA / CCRA certification.

·???????? Ability to work independently, coupled with management and organizational skills.

·???????? Meticulous and detail oriented.

·???????? Bilingual (English/French ideal).

·???????? Proficiency in the use of the Microsoft Office Suite and specialized software for electronic databases such as CRF2, INFORM3 , e-Clinical, TrialStat, OC-RDC, etc.

·???????? Understanding of the regulatory context, good clinical practices, and standard operating procedures

·???????? Availability to travel frequently.

·???????? Ability to interact productively and effectively influence others.

·???????? Ability to set and communicate goals, and to drive efforts, overcome obstacles and achieve results within budget and timeline specifications.

·???????? Interpersonal and communication abilities.

·???????? Team building and team-oriented approach.

·???????? Willing to contribute at all levels.

·???????? High ethical standards and integrity.

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Additional attributes:

·???????? Highly self-motivated?

·???????? Able to work independently and as part of a study team

·???????? Detailed oriented with a view to the overall scope of the project?

·???????? Organized

·???????? Accountable?

·???????? Self-directed learner

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Salary Range: ?90,000-105,000 annually

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This is an opportunity to work in a small, entrepreneurial, and highly motivating environment, with a strong emphasis on work/life balance and a supportive company culture. We offer a competitive salary, excellent benefits, and career development opportunities.

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How to Apply

Please send your CV and cover letter to [email protected] .

While only short-listed candidates will be notified, we thank each applicant for their submission.