The Emmes Company, LLC ("Emmes") is searching for a Home-BasedClinical Research AssociateIII with experience in vaccine research studies.
Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over eighthundred staff worldwide with offices located in Frederick, Maryland, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.
Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We provide statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.
The Clinical Research Associate in collaboration with 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 remote assessment of site activities, in addition to, onsite Investigator/site training, site qualification, initiation, interim, for cause, pharmacy and close out site monitoring visits. The Clinical Research Associate works closely with project team members to plan and support coordination of research at participating clinical sites. This goal is achieved by evaluating compliance with regulatory requirements, ICH guidelines, Standard Operating Procedures (SOPs), the study protocol and research objectives of the clinical trial. 75% travel each month is required. Travel may include international travel dependent upon project assignment.
- Possesses detailed and current knowledge of the study protocol, site monitoring plan, study manuals, Good Clinical Practices and Code of Federal Regulations and local country regulatory requirements
- Schedules and conducts site visits, including site qualification, initiation, interim, for cause, pharmacy and close out monitoring visits. Prepares and obtains required project approvals and ensures distribution of site visit reports within timelines, and tracks outstanding action items or tasks
- Collects, reviews, maintains and/or provides required regulatory documents to designated sponsor or project representative. Review includes assessment of completeness, accuracy and compliance with regulatory and local agency requirements
- Communicates and coordinates effectively with internal project staff members, site staff, sponsors, clients and other external colleagues
- Coordinates with project team and other study personnel to determine data collection requirements based on the protocol, and may test electronic (or paper) case report forms, or the Monitoring Status Report (MSR) as required
- Reviews, coordinates, contributes to and processes project documents and required reports, such as study protocol documents and consent forms, SAE, project and protocol deviation reports, accrual and other study status and/or study website reports
- Reviews and contributes to the development and/or modification of study and project materials, such as Manual of Operating Procedures (MOPs), Monitoring Plans, User Guides and Data Management Handbooks
- Works with sites during site monitoring visits to resolve protocol monitoring module discrepancies, as well as data discrepancies resulting from queries and Missing Forms & Values Reports
- Attends and participates in sponsor, project and functional group meetings
- Schedules and completes training in accordance with project needs and Emmes travel policies
- Bachelor's degree in a scientific discipline or equivalent experience; combination of training and experience will be taken under consideration
- Ability to travel domestically and internationally up to 75%
- Minimum of 4-6 years of clinical research/monitoring experience, specifically in vaccine research
- Demonstrated understanding of regulatory obligations for a Clinical Research Associate and relevant ICH guidelines
- Successful completion of ACRP CCRA or equivalent certification within one year of hire/transfer date
- Skilled in prioritization, problem-solving, organization, critical thinking, decision-making, time management and planning activities
- Self-motivated and high attention detail required
- Ability to collaborate with internal and external colleagues and work well in team-oriented setting
- Excellent oral and written communication; exceptional interpersonal skills
- Ability to work remotely with a high degree of independence
- Skilled in data management/computer proficient in Microsoft Office
Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.
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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 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.