Research Associate, Patient-Centered Outcomes

Ardea Outcomes is seeking a Research Associate to join our growing team. The role will report directly to the Director of Patient-Centered Outcomes and work closely with other members of the Research Department. This position will be remote within Canada, and the candidate will be based out of their designated home office.

About Ardea Outcomes

Ardea Outcomes is a purpose-led boutique contract research organization focused on improving health outcomes through patient-centered research. We work with pharmaceutical companies, patient advocacy groups, and academic experts to elevate the patient voice in clinical research, moving from "what's the matter" to "what matters most" for patients and caregivers through Goal Attainment Scaling (GAS). 

Our offerings include end-to-end research services and digital products:

• GAS Training and support for Raters and Clinicians
• Protocol and GAS study plan development
• Licensing and support for our patent-pending GAS software, GoalNav ®
• GAS clinical data management and data analytics services
• Medical writing and results dissemination at conferences and key industry events

Ardea Outcomes works to a high standard of excellence with top pharmaceutical companies in the clinical development and post-market space.

Our Culture

Founded in 2000, Ardea Outcomes is a globally recognized, remote-first company registered in Halifax, Nova Scotia, with employees spanning the country. We are a small, multidisciplinary team focused on our values of achieving impact through excellence and collaboration. 

Job Overview

The Research Associate role works on global clinical trials and patient-centered studies across multiple disease areas. Leveraging their skills and experience, the Research Associate will have the opportunity to work on cutting-edge research with multinational pharmaceutical companies, med-tech companies, patient advocacy groups, non-profits, and academic centers. This pivotal role is entrusted with spearheading qualitative research endeavors and contributing to the intricacies of our clinical trial operations. From meticulously planning and executing research activities to conducting in-depth data analysis, this position requires a keen eye for detail and a profound understanding of qualitative research methodologies. Collaboration with internal and external stakeholders is fundamental to ensure regulatory compliance and contribute to enhancing our Goal Attainment Scaling (GAS) research practices.

Purpose Driven Position

The Research Associate is a linchpin for our collective success, particularly in qualitative research. Their expertise in this domain is paramount for maintaining the integrity and rigor of our research projects. Through effective communication and collaboration with clients, stakeholders, and internal teams, they ensure that qualitative research activities are executed seamlessly, fostering trust and facilitating project success. Furthermore, their commitment to staying abreast of industry trends and driving improvements in qualitative research practices underscores their indispensable role in advancing our organization's mission and objectives to make an impact through Goal Attainment Scaling.

What You'll be Doing

General Conduct of Research

• Plan, prepare, and gain IRB approval of study documents for qualitative research studies.  
• Conduct literature reviews and summarize research findings into scientific outputs.
• Perform data collection through qualitative interviews, focus groups, and surveys.
• Perform quantitative and qualitative analysis of data to interpret and summarize research outputs into required graphs, tables, and figures using the appropriate software tools and coding languages.
• Create and deliver high-impact reports, presentations, and research outputs such as manuscripts, abstracts, and posters. 
• Generate and review required study documentation following company quality, regulatory, and sponsor requirements.

Clinical Research Execution

• Assist with preparing Goal Attainment Scaling (GAS) study documents for clinical trials, including protocols, GAS study plans, statistical analysis plans, training plans and materials, IRB documents, and other required documents.
• Execute project planning and risk management in areas of duty according to Ardea Outcomes, sponsors, and regulatory guidelines, ensuring tasks are completed on time and within budget.
• Effectively communicate with clients, key stakeholders, sites, collaborators, and internal project teams throughout the project lifecycle.
• Develop and execute training functions for studies, including training materials (presentations, participant materials, newsletters, and manuals), site onboards, training system module development, execute webinars, review goals/data, and support site personnel.
• Conduct assigned study activities strictly following applicable plans, processes, and regulatory standards.
• Recommend and drive continuous improvement of processes, systems, and tools to enhance Ardea Outcomes' clinical research services/products and increase efficiency.
• Review methods and documents within the department to ensure scientific alignment and success of projects and escalate to leadership as needed.

What We Are Looking For

• A Master's degree in epidemiology, psychology, outcomes research, sociology, or related areas is required.
• At least 2 years of relevant research experience in qualitative research methods, data collection, and qualitative data analysis.
• Experience using qualitative software (such as NVivo or Atlas.ti) is preferred.
• Experience executing quantitative analysis and knowledge of statistical programming is an asset.
• Experience working in a relevant industry or contract research organization is an asset.
• Knowledge of ICH GCP, 21 CFR Part 11 compliance, or experience working in a highly regulated industry would be an asset but is not required.
• A passion or a willingness to learn about Patient-Centered Outcomes research.
• Strong IT literacy is required.
• Strong organization and project planning skills; ability to work on multiple tasks simultaneously.
• Strong written and verbal communication in English is required.
• Strong judgment, analytical, interpretative, and problem-solving skills.
• Ability and willingness to rapidly learn and develop skills.

Why You'll Love Working at Ardea Outcomes:

We offer competitive compensation packages to match your skills and experience, including extensive vacation, holidays, and sick time off. Group health and dental benefit contributions, home office setup, and professional development opportunities are also part of our core offering.

We want to thank all applicants for their interest. Please note only those selected for an interview will be contacted.

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