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Company Name : Actalent
Location : Miami, FL 33101
Position : Remote Clinical Research Associate
Job Description : Equivalent Experience
Job Description:
The Sr. CRA (SCRA) is a high-profile role within the department; using their experience as a knowledge resource to help other CRAs develop their skills. The SCRA will provide expert advice, mentorship and general direction to clinical monitoring team activities for designated projects, and to monitor specified sites to ensure quality and integrity of data, compliance with SCRI or client’s standard operating procedures (SOPs), clinical monitoring plan, ICH GCP, regulatory standards, ensuring study completion on time and within budget.
The SCRA is an essential member of a Development Innovations project team responsible for the execution of a clinical research project. The degree of responsibility given to a SCRA shall reflect his/her experience and the level of contribution, which he/she can make to that project.
Your duties:
You will report directly to Manager, CRA on general issues
You will report to the Project Manager or Project Lead for study specific issues
You will conduct all activities according to the defined project-specific quality and performance standards as well as applicable SOPs, ICH/GCP, and local requirements
You will contribute to the departmental on-site Quality Control program by setting a schedule of site assessment visits for the project with the Services Monitoring Management Team.
You will ensure awareness of project-specific quality and performance standards (within Services Monitoring Standards) and ensure that these are well documented, communicated, and understood.
You will be accompanied by Project Manager, Project Lead, or CRA Manager on selected visits (qualification, initiation, monitoring, and close out visits.)
You will support the development and delivery of department training days.
You will actively participate in training sessions and workshops, including presenting reports from any conferences attended.Mandatory:
Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement”
During your employment with Sarah Cannon you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
Qualifications:
Bachelor’s College Degree (4 year program)
Three years direct oncology monitoring experience in Phases l – lll
Performed all visit types (site evaluation/selection, initiation, routine monitoring, and close-out)
Proven leadership skills
It would be helpful if you had:
At least five years direct oncology monitoring experience in Phase l – lll in solid and liquid tumor types
Have performed all visit types (site evaluation/selection, initiation, routine monitoring, and close-out)
Proven leadership skills
Previous experience in a Sr. CRA role
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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