American remote worker
The Clinical Research Associate is responsible for monitoring clinical study sites to ensure compliance with the clinical trial protocol, verifying the activities of clinical sites, performing on-site visits, reviewing forms for case report (CRF) and communicate with clinical research researchers. 75% monthly trips may be required.
- Assistance in the development and / or review of study-related material, including protocols, informed consent forms, monitoring plan, monitoring documents, etc.
- Participates in the identification and recruitment of investigators and assists in the development of subject recruitment strategies and materials.
- Ensures that all visits are carried out in accordance with FDA regulations and company standard operating procedures.
- Ensures adequate reporting / follow-up of adverse events, protocol deviations and subject status.
- Identifies areas requiring follow-up and improvement at each clinical study site and reports the results to the ARC manager.
- Serves as the point of contact for study site staff to answer questions and resolve study issues.
- Ensures the proper maintenance of essential documents required at the site. Help with configuration, maintenance and reconciliation of the master test file.
- Prepares and attends project team meetings and provides updates on project status and site specific performance.
- Works collaboratively and effectively in a project team environment.
- Bachelor’s degree, preferably in a scientific discipline or equivalent experience may be considered in place of the diploma
- Minimum of 1 to 2 years of on-site monitoring experience required
- Experience in clinical trials in oncology is preferred
- A first experience in CRO is preferable
- Demonstrated understanding of regulatory obligations for a Clinical Research Associate and relevant ICH guidelines
- 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
- Initiative and ability to work remotely with a high degree of independence
- Data management skills / proficiency with Microsoft Office
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with volunteer opportunities through our Emmes cares community engagement program. We offer a competitive benefit package focused on the health and needs of our growing workforce, including:
- 401k and profit sharing plan
- Work from home anywhere in the United States
- Casual dress code and work environment
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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 characteristics protected by law. .
Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. People with health concerns or sincere religious beliefs or practices that prevent them from getting the vaccine can apply for an exemption from the vaccine requirement.