Note: The job is a remote job and is open to candidates in USA. Advanced Clinical is a successful and stable Molecular Diagnostics Sponsor seeking a Senior Clinical Research Associate to support Oncology Diagnostics studies. The role involves performing site start-up activities, conducting site monitoring visits, and managing ongoing site support and documentation related to clinical trials.
Responsibilities
- Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations
- Develop study-related documents with minimal Clinical Trial Manager guidance including protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required
- Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight
- Support the Clinical Data Management team in the design and content of case report forms, completion guidelines, including support and testing of an EDC
- Manage the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements
- Oversees clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information
- Train CROs, vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
- Develop new study monitoring plans, and monitor studies following study monitoring plans to identify protocol deviations or data discrepancies
- Perform study activities including consent participants for research studies, ethics board submissions, participant data and sample tracking using in-house and CRO databases, for studies
Skills
- 4 years of Regional/Site Monitoring experience
- Experience working on oncology trials
- Tech Savvy, ability to pick up new systems quickly
- Recent Study Start-Up, SIV visit experience a hard requirement
- Remote Monitoring experience a plus
- Experience working in google workplace a plus
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