Senior Clinical Research Associate

March 15

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ResearchEd

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ResearchEd is an education policy research nonprofit providing objective analysis, deep insights, and detailed recommendations for education institutions and research organizations seeking to support equitable student outcomes and promote community and economic development through education. ResearchEd conducts student-centered work, particularly focusing on underserved groups, and provides research, data capacity building support, and advocacy. Their mission is to empower action in education, aiming for equitable access to education as a catalyst for community success and social justice.

education research • public policy • community college • rural education • Postsecondary Data Partnership

11 - 50 employees

Founded 2020

📚 Education

🤝 Non-profit

🌍 Social Impact

📋 Description

• Monitor clinical trial programs and manage regional clinical trial sites to support biological and pharmaceutical developmental programs in a manner consistent with relevant regulations including ICH/GCP and PhRMA guidelines along with Catalyst Clinical Research’s applicable SOPs and working practices. • Collaborate with an assigned clinical research team to provide input on site selection, study initiation procedures, conflict resolution, and audit responses. • Travels up to 80% within an assigned territory. • Conduct site evaluations, study initiations, routine monitoring, site close-outs, and FDA audit preparations. • Develop territory to broaden selection of research study sites. • Effectively communicate with site study staff and Catalyst clinical research personnel to report study site status. • Assist with Investigator Meetings planning/presentations, data collection, and FDA submission preparations. • Maintain a home office if working remotely.

🎯 Requirements

• Bachelor’s degree in a science or health-related discipline or equivalent of 7 years industry experience. • Minimum of 5 years’ experience in clinical research with direct site monitoring experience with a sponsor company or CRO and 3 years of recent oncology clinical trial experience. • Strong knowledge of clinical trial monitoring, regulatory compliance, clinical research methodology and all applicable regulations and guidelines. • Strong organizational and time management skills and the ability to work independently. • Excellent communication and interpersonal skills. • Flexibility and ability to travel routinely to meet project requirements. • Strong knowledge of standard computer applications.