4 Jobs in bethesda, md
intellectt is Hiring a Clinical Research Associate (CRA) Near Bethesda, MD
Location: Remote (MD, DC, VA)
Onsite/Remote: Remote with few site visits in Bethesda, MD
Summary: Manage clinical monitoring processes to ensure site compliance with regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Coordinate interim and closeout activities to meet study timelines and metrics. This is a contract traveling CRA position if necessary.
Primary Responsibilities
- Strong knowledge of oncology and phase 1 studies
- Review regulatory documents and monitor adherence to collection processes
- Write clinical monitoring plans, source documents, and study tools as needed
- Conduct interim and closeout site visits, document findings, re-train site staff, and implement corrective actions
- Ensure study documents (e.g., case report forms, source documents, adverse events) are complete and accurate
- Reconcile clinical supplies and drug accountability records
- Collaborate with data management to resolve data queries
- Prepare reports, letters, and other trial-related documents
- Implement and monitor processes for SAEs, safety documentation, and pregnancies
- Facilitate investigator site payments
- Maintain clinical trial tracking information and assist with audit/inspection responses
- Develop relationships with study personnel, manage study issues, and support milestone achievement
- Assist with auditing study files and document reconciliation
- Familiarity with medical terminology, protocol, clinical trial processes, regulatory requirements, and company SOPs
- Strong knowledge of oncology, preferred experience with NCI
- Understanding of ICH/GCP Guidelines and EDC processes
- Ability to establish rapport with site personnel and colleagues.
Job Summary
Contractor
Business Services
$69k-91k (estimate)
06/26/2024
12/21/2024
intellectt.com
ISELIN, NJ
200 - 500
2018
KIRAN MADALA
$5M - $10M
Business Services
Related Companies
About intellectt
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.
The job skills required for Clinical Research Associate (CRA) include Clinical Research, Clinical Trial, SOP, Clinical Monitoring, Oncology, Accountability, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Research Associate (CRA). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Research Associate (CRA). Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Research Associate (CRA) positions, which can be used as a reference in future career path planning. As a Clinical Research Associate (CRA), it can be promoted into senior positions as a Clinical Research Associate II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Research Associate (CRA). You can explore the career advancement for a Clinical Research Associate (CRA) below and select your interested title to get hiring information.
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