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Clinical Research Associate
2 months ago
We are seeking a Clinical Research Associate to support our client in their clinical research initiatives.
Position Title: Clinical Research Associate
Location: Remote
Employment Type: Contract
Compensation: $38.56/hr - $43.56/hr
Key Responsibilities:
- Assist in the evaluation and upkeep of study and site documentation, aiding in the management of document files and related quality assurance activities.
- Identify and analyze inconsistencies in study documentation by utilizing clinical protocol and Good Clinical Practice (GCP) knowledge, and develop strategies to prevent recurrence throughout study phases.
- Conduct internal reviews of relevant documentation and may assist during audits by regulatory authorities to ensure compliance with Good Documentation Practices, internal Standard Operating Procedures (SOPs), and applicable regulations.
- Evaluate existing processes, identify areas for improvement, and suggest solutions to enhance efficiency in tracking and reporting.
- Support the timely review, tracking, and processing of study, site, and vendor payments.
- Assist in reconciling and monitoring payment queue status and totals by cost center.
- Collaborate with cross-functional teams for general site payment issue resolution and support.
Preferred Qualifications:
- Experience with managing documents within a Trial Master File (TMF) is preferred.
- Familiarity with processing and tracking study, site, and vendor invoices and payments is advantageous.
- Strong verbal and written communication skills, attention to detail, and critical thinking abilities.
- Ability to work independently and manage time effectively.
- Proficiency in applying accounting and mathematical principles as required.
- Background in clinical research, with knowledge of the clinical study process, monitoring, GCP, and relevant regulations.
- Understanding of high compliance requirements and the importance of protecting the rights and well-being of human subjects during clinical studies.
Education and Experience:
- Bachelor's Degree or equivalent in a relevant field.
- 0-2 years of experience in a related role.
- Experience with TMF document management systems, Clinical Trial Management Systems (CTMS), and Coupa is preferred.
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