Remote worker in Canada
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 stands for Truth. Through decades of experience, we have learned that collaborative relationships thrive and that human health is good 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 set us apart as an organization: integrity, agility, passion for excellence, collaborative partnerships and curiosity intellectual. We are a trusted partner for clients who share our passion for improving public health in an ever-changing world of scientific research.
If you share our motivations and our passion for research, come join us! You will join a collaborative culture that empowers every Emmes employee – from entry level to senior executive – to contribute to our clients’ success by sharing ideas openly and honestly.
The Clinical Research Associate, in collaboration with the project teams, is responsible for planning, monitoring and coordinating clinical research studies at external study sites. As part of these activities, the Clinical Research Associate may also perform a remote assessment of site activities, in addition to on-site investigator / site training, site qualification, initiation, ‘interim, rationale, pharmacy and fence site surveillance visits. The Clinical Research Associate works closely with members of the project team to plan and support the coordination of research at participating clinical sites. This goal is achieved by assessing compliance with regulatory requirements, ICH guidelines, standard operating procedures (SOPs), study protocol, and clinical trial research objectives. 75% of trips per month are necessary. Travel may include international travel depending on the project assignment.
- Has detailed and current knowledge of study protocol, site monitoring plan, study manuals, good clinical practice and code of federal regulations and local regulatory requirements of the country
- Schedule and conduct site visits including site qualification, initiation, interim, cause, pharmacy, and close-out follow-up visits. Prepares and obtains required project approvals and ensures distribution of site visit reports on time, and tracks action items or outstanding tasks
- Collects, examines, maintains and / or provides required regulatory documents to the designated sponsor or project representative. The review includes assessment of completeness, accuracy and compliance with regulatory and local agency requirements
- Communicates and coordinates effectively with internal project staff, site staff, sponsors, clients and other external colleagues
- Coordinates with the project team and other study staff to determine data collection requirements based on protocol, and may test electronic (or paper) case report forms or report follow-up status (MSR) as needed
- Reviews, coordinates, contributes and processes required project documents and reports, such as study protocol documents and consent forms, SAE reports, project and protocol deviation reports, accumulation and d ” other reports on the status of the study and / or the study website
- Reviews and contributes to the development and / or modification of study and project documents, such as the operating procedures manual (MOP), monitoring plans, user guides and management manuals data
- Works with sites during site monitoring visits to resolve protocol monitoring module discrepancies, as well as data discrepancies resulting from queries and reports of missing forms and values
- Attends and participates in meetings of sponsors, projects and functional groups
- Plans and completes training in accordance with project needs and Emmes travel policies
- Bachelor’s degree in a scientific discipline or equivalent experience; a combination of education and experience will be taken into consideration
- Ability to travel at home and abroad up to 75%
- Minimum of 4 to 6 years of clinical research / surveillance experience.
- Demonstrated understanding of regulatory obligations for a Clinical Research Associate and relevant ICH guidelines
- Successful completion of the ACRP CCRA or equivalent certification within one year of the date of hire / transfer
- Skills in prioritization, problem solving, organization, critical thinking, decision making, time management and planning activities
- Personal motivation and great attention required
- Ability to collaborate with internal and external colleagues and to work well in a team
- Excellent oral and written communication; exceptional interpersonal skills
- Ability to work remotely with a high degree of independence
- Data management skills / proficiency with Microsoft Office
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The Emmes Company, LLC is an Equal Opportunity Affirmative Action Employer and does not discriminate in its selection and employment practices. All qualified applicants will be considered for employment regardless of race, color, religion, gender, national origin, political affiliation, sexual orientation, gender identity, marital status , disability, protected veteran status, genetic information, age or other legally protected characteristics. .