Clinical Research Coordinator

2 months ago

Edmonton, Canada Pulse Medica Full time

**Clinical Research Coordinator**

Embark on an exciting journey at PulseMedica Take charge of coordinating the development of clinical research protocols and studies, regulatory path-to-market strategy, and FDA / Health Canada submissions for class II and III medical devices. Play a key role in designing and supporting clinical operations, and collaborating with stakeholders. Support the development of impactful publications and presentations, showcasing the clinical benefits of PulseMedica’s groundbreaking technologies. If you're a dynamic team player with a passion for clinical innovation, we want you on our team

**About Us**

**PulseMedica**, proudly **Great Place to Work Certified** for the third consecutive year, is a fast-growing, innovative medical device startup. We combine cutting-edge research, advanced technology, and production excellence to tackle ophthalmic diseases and disabilities. Our mission is to provide novel treatment options through state-of-the-art solutions, blending real-time classical computer vision, deep learning algorithms, 3D eye imaging, and high-precision laser surgery. With a commitment to revolutionizing ophthalmic treatments, we are dedicated to delivering exceptional outcomes that prevent blindness and disabilities caused by eye diseases. At PulseMedica, we foster a collaborative and supportive environment where talent thrives, and our team’s collective impact drives change in the field of eye care.

**The Opportunity**

**Responsibilities**:

- Support the development of pre-clinical and clinical research protocols and policies.
- Assist with planning and liaising with regulatory consultants for approvals from Health Canada, FDA, and European authorities, including 510(K) and De-Novo.
- Regularly engage with medical advisory board members, Key Opinion Leaders (KOLs), investigators, and representatives at clinical sites.
- Prepare comprehensive study documentation such as protocols, case report forms (CRFs), memos, correspondence, reports, and other required documents.
- Maintain data collection and analysis systems in support of research protocols, coordinating the collection and analysis of research data.
- Ensure timely collection of study documentation by obtaining and maintaining all necessary records according to procedures and regulations.
- Coordinate training and support for research site staff, oversee daily operations of research activities, and serve as a point of contact for internal staff and external stakeholders.
- Monitor the progress of research activities, maintain records, and prepare periodic and ad hoc reports for investigators, administrators, funding agencies, and regulatory bodies.
- Coordinate and support regular advisory board and steering committee meetings as required.
- Assist with project management for publications and presentations.
- Maintain a portfolio of conference presentations, publications, and white papers that illustrate the clinical benefits of PulseMedica’s technologies.
- Perform miscellaneous job-related duties as assigned, providing support for other programs as needed.

**Qualifications**:

- Bachelor’s degree in a scientific or health-related program is preferred.
- Minimum of 3 years experience in the medical device industry.
- Minimum of two (2) end-to-end ownerships and successful regulatory approval of class II and/or class III medical devices.
- Familiar with medical terminology, clinical medicine, pre-clinical and clinical trials, and Good Clinical Practice concepts.
- Professional demeanor with robust communication skills suitable for interactions with the public, physicians, health care professionals, and researchers.
- Ability to thrive both independently and as part of a dynamic team in a fast-paced environment.
- Ability to demonstrate strong interpersonal, customer service, and multi-tasking skills.
- Ability to be flexible, organized, detail-oriented, proactive, and demonstrate a tenacious follow-through approach.
- Ability to work effectively under pressure and manage multiple deadlines.

**Highly Desired Skills and Experience**:

- Minimum of 3 years experience in ophthalmology related industry.
- Proficiency in electronic health systems and databases used in research environments, or a willingness to learn and demonstrate proficiency.
- Knowledge of federal, state/province, and local regulations, including health data privacy policies and procedures.

**Duration**: Full-Time Permanent (40 hours per week)

**Salary**: Commensurate to experience and qualifications

**Location**: Edmonton (Hybrid)

**What you can expect from PulseMedica**:

- Competitive compensation, health, dental and vision benefits and the option to participate in our employee stock option plan
- Free on-site gym (Jackson’s Gym)
- A role that contributes to helping change people’s lives by enhancing their vision
- A unique opportunity to build, grow, and be part of a team that is going to revolutionize a multi-billion dollar

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