Senior Clinical Research Associate

Who we are:

Response Biomedical Corp. has been transforming acute care diagnostic testing, with the central focus on improving patient outcomes and healthcare reform for over 20 years. Response Biomedical fosters a values-based culture, committed to making diversity and inclusion our way of doing business. We believe the people we work with including our partners, medical teams, and employees are the cornerstone of our success.

What we do:

Our RAMP platform is a global leader in diagnostic testing solutions for use in cardiovascular, infectious disease, sepsis, women’s health, arbovirus, and biodefense. We understand the stresses associated with rapid, accurate diagnosis when every minute counts, and are committed to collaborating with the teams that are dedicated to saving lives. We do this by providing lab-quality results within minutes that medical teams can trust while reducing the total cost of care.

Who we are looking for:

We are seeking a motivated, dynamic, solutions-focused, and creative individual to join our Clinical Team. This position will assist with the execution of clinical studies, including the development, initiation through to close out, including monitoring, of investigational sites to ensure compliance, and to assist with the study management activities for the purpose of improving patient outcomes and saving lives globally.

Key Responsibilities:

Clinical Investigations

• Assists with the development of study related documents including, but not limited to: Clinical Investigation Plans, Statistical Analysis Plans, Case Report Forms, Monitoring Plans, Data Handling Plans, Essential Document Development, etc.
• Coordinates, schedules, and conducts site qualifications, initiations and closeouts at sites.
• Assists in collection and review of site activation documentation.
• Establishes and maintains regular contact with investigative site personnel to ensure compliance and assessment of accrual rates.
• Tracks and reports the progress of assigned clinical study sites, i.e., screening, enrollment, data collection, and adverse event documentation.
• Coordinates, schedules, and conducts monitoring visits at investigational sites, both remote and in-person, to ensure compliance to the clinical protocol, regulations, and timely receipt of data including source data verification, writing monitoring reports and follow-up letters, and ensuring accurate device accountability.
• Assists in data management with query generation and resolution and reporting of adverse events.
• Assists with the development and implementation of site corrective actions as needed to address any compliance issues.
• Assists the Clinical Manager with writing the Clinical Reports and Study Summary Reports.
• Contributes to ongoing Standard Operating Procedure (SOP) development and review.
• Assists sites with audit preparedness.
• Leads ethics submissions, including but not limited to, initial submissions, the maintenance of annual renewals/continuing reviews, and submissions for amendments.
• Ensures ClinicalTrials.gov is up to date.

Marketing

• Assist with the review of claims made in marketing materials and collateral as it pertains to references made on clinical data and outcomes.
• Provide input as required into abstracts, manuscripts, and presentations.

Regulatory Support

• Aids with the IVDR activities that are annually assigned to Clinical Affairs, such as providing clinical data, literature, and references.
• Assists in the compilation of elements required for regulatory submissions as required.

Leadership

• Ability to oversee and mentor junior clinical team members.
• Ability to work with sites on the required training needed to participate in one of our clinical investigations.

Education, Work Experience, Knowledge, and Skills:

Formal Education:

• Minimum requirements: Associate or Bachelor’s Degree (e.g., Science, Business or Marketing) or combination of education and work experience in biotechnology to be considered.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook, Project). SOCRA and/or ACRP Certification preferred.

Work Experience:

• Minimum of five (5) or more years experience in a Clinical Research Associate (CRA) or Clinical Affairs role.
• Previous Sr. CRA experience is an asset.

Skills and Knowledge:

• Able to communicate effectively, both orally and in writing, with good interpersonal and diplomacy skills.
• Strong problem identification and objection resolution skills.
• Able to build and maintain lasting relationships with sites.
• High attention to detail and degree of accuracy.
• Able to work independently and in a team environment.
• Must have the ability to work in a fast-paced, dynamic environment.
• Strong work ethic and positive dynamic team attitude.
• Strong knowledge and understanding of Good Clinical Practices (GCP).
• Strong knowledge and understanding of the medical device regulations and compliance guidelines for clinical studies, particularly in Canada, the United States of America, and Europe.
• Travel is required and will vary – anticipated amount not to exceed 30%.

The starting salary for this position ranges from $80,000 to $90,000 annually, depending on the candidate's experience and qualifications. Our salary structure is aligned with market standards and is finalized considering factors such as job-related expertise, skills, education, and experience.

Please note that this position is only available to candidates who are authorized to work in Canada, and local hybrid candidates are preferred.

• We regret that relocation will not be provided.

• While we appreciate the interest of all applicants, only those candidates selected for interview will be contacted.

We're committed to a diverse and inclusive workplace. We welcome applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. All employment decisions are based on business needs, job requirements and individual qualifications.