Home-Based CRA Manager
Canada Remote Worker
The Emmes Company, LLC (“Emmes) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.
Our “Character Achieves Results” culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.
If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients’ success by sharing ideas openly and honestly.
The CRA Manager in collaboration with project team leaders is responsible for planning, monitoring and coordinating clinical research studies at external study sites. As part of these activities, the CRA Manager will oversee the CRAs for which they are assigned. The CRA Manager ensures monitoring metrics are adhered to and all monitoring deliverables are provided with high quality and consistent with SOPs and project Plans. This position may be home or office-based in any Emmes location. Travel is not expected to be more than 25%.
- Coordinates all monitoring aspects in the execution and support of clinical trial activities
- Supervises and ensures CRA team members are compliant with SOPs, sponsor and regulatory agency expectations for site monitoring activities
- Participates on internal, site and sponsor teleconferences and meetings to address monitoring activities outlined in statements of work
- Critically reviews study protocols, study documents, monitoring reports and Sponsor required plans for communication, monitoring and other required plans
- Implements full scope and risk-based monitoring programs
- Develops and implements tracking systems for key monitoring activities and evaluates defined milestones for these activities
- Reviews and approves travel, expense report and timesheets
- Conducts co-monitoring activities (feasibility, qualification or selection, interim, close out visits, for cause and other visits) as required
- Participates as a team leader in project planning, implementation, problem solving, tracking milestones and deliverables
- Liaises with the Sponsor and the study team
- Leads in the development of key monitoring deliverables such as clinical monitoring plans and site visit report templates
- Helps to identify, train, and mentor new CRAs and monitoring staff
- May prepare monitoring budgets and statements of work for existing and new proposals
- Participates in corporate initiatives as requested
- Minimum of a Bachelor’s degree and a background in clinical research, public health, biological sciences, or other related fields
- Minimum of 5 years of monitoring experience in clinical trials
- Proven supervisory skills and excellent verbal and written communication skills
- Ability to independently plan, lead and summarize conference calls or meetings with project staff, clinical staff, vendors and sponsor representatives
- Prior experience in any of the areas of ophthalmology, transplantation, neurology, vaccine and infectious diseases, cancer, maternal/child health and substance abuse preferred
- ACRP CCRA or equivalent certification preferred
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Emmes is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.Apply Now