General Summary

MolecuLight Inc. is a Medical device company in Toronto, specializing in point-of-care diagnostic imaging, developing a handheld optical imaging platform. MolecuLight’s products are imaging systems with primary applications in bacterial imaging and measurements for wound care. We are currently seeking a skilled and experienced Clinical Trial Associate to join our team.

Accountability

The Clinical Trial Associate has principal responsibility for supporting clinical trials data management, including capturing and recording clinical trials data, monitoring and promoting the quality and integrity of data, preparing summary reports and assisting with scientific content (posters, publications, marketing material).

Data management is performed in accordance with trial protocol, procedures, guidelines and professional standards of practice. All data must be complete, accurate, and timely and must be in compliance with applicable ICH-GCP, FDA and US federal code, Tri-Council regulations, and other applicable international regulations. The Clinical Trial Associate must be able to interpret the applicable regulations in order to ensure compliance. Quality assurance procedures developed within an ISO 13485:2016 certified Quality Management System are utilized to ensure high quality data is obtained.

The Clinical Trial Associate is also responsible for supporting medical device testing both in-house and in clinical setting following by facilitating feedback meetings for team review.

The Clinical Trial Associate role is located onsite at the Toronto offices and will require travel within the GTA. Some travel within Canada or US may be required (<10%).

Duties and Responsibilities

• Coordinates and monitors multiple clinical trials including the monitoring of the progress and deadlines of trial activities, developing and maintaining records of trial activities, and establishing and maintaining operating policies and procedures, including quality assurance.
• Prepares, monitors and maintains study documents and other trial files; coordinates research activities pertaining to each study including subject recruitment, or scheduling for enrollment for internal studies.
• Performs clinical activities such as obtaining consent, imaging patients, and documenting data.
• Builds and maintains solid and professional relationships with site staff
• Synthesizes, interprets and presents research-related information in written reports and manuscripts. Performs literature review.
• Provides an understanding of trial design and clinical research ethics processes.
• Conducts device testing and compiles data and feedback for team evaluation.
• Assists in scientific communication activities, including poster preparation, scientific publications and marketing projects.
• Works within all regulatory frameworks including Good Clinical Practice (GCP), ICH Guidelines, ISO 14155 requirements and ISO 13485:2016 certified Quality Management System
• Serves organizational and division objectives, supports team members and may have additional duties assigned.

Education and Experience

Bachelor’s Degree in life sciences; Master’s Degree an asset

Minimum experience of 2 years in clinical research

Experience using statistical analysis and data management software; statistical training is an asset.

Data management and analysis experience

Scientific communication experience such as scientific poster creation and publication writing

Key Attributes (experience, skills and technical knowledge)

Excellent oral and written communication skills

Excellent planning and organizational skills with effective time management

Meticulous attention to detail

Excellent interpersonal skills

Independent and capable of working with minimal supervision

Ability to chair meetings

Initiative and problem-solving skills

Thorough understanding of clinical research principles and processes. Ability to input into process initiatives, and procedures related to Good Clinical Practices (GCP).

Good understanding of FDA, Health Canada, and EU Directive regulations, as well as ICH Guidelines and ISO 14155 requirements as they related to Good Clinical Practice

Proficient knowledge of Microsoft Office Programs, Clinical Database Management

Business acumen

Disclaimer

The above information on this job description and specification has been designed to indicate the general nature and level of work performed by employees within this job. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

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