Senior Clinical Research Associate, CRA
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Job Description
Senior Clinical Research Associate overseeing study monitoring visits and ensuring adherence to protocols. Supporting clinical trials in a remote capacity from the United States.
Responsibilities:
- Performs all study monitoring visits and completes supporting visit reports, including applicable visits such as site/investigator qualification, site initiation, interim monitoring, remote monitoring, and close-out visits
- Trains investigator(s) and site staff on study protocol and all relevant study procedures
- Supports study start-up, conduct, and closeout activities.
- May assist in developing study related plans and documents including clinical protocol, clinical brochures/lFUs, development of CRFs, reviewing informed consent forms, monitoring plan, etc.
- May coordinate IRB/EC approvals
- Functions independently in the field and interacts professionally with all levels of medical and scientific professionals
- Identify early on any unsatisfactory results, operations or specific problems and take immediate action to appropriate groups including escalating and assisting in resolving any study related issues that arise during study conduct
- Assures adherence to GCP, study protocol, procedures, all applicable requirements, and regulations throughout the study monitoring visits
- Responsible for implementing and maintaining the effectiveness of the quality system
- Collect and review site regulatory and essential documents for accuracy and completion
- Maintain the study Trial Master File (TMF)/or eTMF and ensure the Investigator Site Files (ISFs) are current and maintained
- Perform Source Data Verification (SDV) and data cleaning in accordance with study monitoring plan
- Reviewing all study logs and documentation ensuring audit trail and chain of custody is maintained
- Performs Investigation Use Only (IUO) or Research Use Only (RUO) inventory and accountability, in accordance with study monitoring plan
- Facilitates return or destruction of any unused IUO/RUO material as required
- Serve as the primary point of contact for assigned sites and works with sites to resolve data queries and monitoring findings
- Maintains accurate and timely communications with sites and ensures records are filed in TMF/ISF
- Ensures TMF/ISF is audit ready
- Assists with site audit(s) and site quality management activities, as needed
- Tracks site progress against contractual agreements
- Contribute to organizational and departmental process development, improvement, and implementation
- May serve as Lead CRA or Lead monitor for assigned studies
- Works closely with other assigned CRAs to track monitoring deliverables and metrics in accordance with the study monitoring plan
Requirements:
- Bachelor's degree in biological sciences or medical specialty or higher, or equivalent credentials
- 5+ years direct clinical research experience at a sponsor, device manufacturer, IVD, companion diagnostics as a CRA/study monitor, or equivalent experience
- Experience with Electronic Data Capture (EDC) systems and eTMF systems
- Previous experience with Next Generation Sequencing (NGS), lmmunohistochemistry (IHC), and/or pathology
- Knowledge of International Council for Harmonisation (ICH)/GCP guidelines, 21 CFR (Code of Federal Regulations) part 812 (lnvestigational Device Exemption) (IDE)), and monitoring procedures/best practices (ICH E6(R2))
- Demonstrating strong written and verbal communication skills and presentation skills
- Track record demonstrating strong organizational and problem-solving skills
- Track record demonstrating a strong work ethic and ability to deliver tasks on time
- Proficient with Microsoft Office Suite including automation tools
Benefits:
- eligibility for bonus
- stock
- benefits
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